Sharon Worcester

BOSTON – A family-focused diabetes self-management education program was feasible, well received, and more effective in African American patients with type 2 diabetes who brought along a household family member than among those who participated alone, according to findings from a randomized study.

In 21 participants who were randomized to attend the diabetes self-management education (DSME) program with a household family member or companion (HFMC), and who completed the study, significant reductions were seen at 3 months in body mass index, blood pressure, and cholesterol levels, but the same was not true among 27 participants who attended alone, Natasha Greene, Ph.D., reported at the annual scientific sessions of the American Diabetes Association.

BMI among those who brought an HFMC was reduced from 37.4 to 36.6, while those who attended alone experienced a reduction from 36 to 35.7. Mean systolic blood pressure was reduced from 154.2 mm Hg to 139.5 mm Hg, and from 146.3 mm Hg to 140.2 mm Hg in the groups, respectively. Mean diastolic blood pressure was reduced from 75 mm Hg to 69 mm Hg, and increased from 72.2 mm Hg to 73.5 mm Hg in the groups, respectively, said Dr. Greene of North Carolina Central University, Durham.

Mean total cholesterol was reduced from 175.7 mg/dL to 164.1 mg/dL, and increased from 167.2 mg/dL to 171.3 mg/dL and low density lipoprotein cholesterol was reduced from 106 mg/dL to 96.3 mg/dL, and increased from 95 mg/dL to 99 mg/dL in the groups, respectively, she said, noting that hemoglobin A1c levels improved, but not significantly, in either group.

“DSME interventions have drastically increased over the last 10 years. Most interventions have been successful, but statistically significant outcomes either weakened after 6-12 months or completely disappeared,” Dr. Greene said, adding that it is “therefore essential to develop some interventions that have sustainable outcomes, especially in African Americans.”

African Americans continue to experience higher rates of diabetes prevalence, complications, and premature age-adjusted deaths, compared with non-Hispanic European Americans, she explained.

“Moreover, African Americans report difficulty following recommendations because the regimens interfere with work, family life, beliefs, family food preferences, and the socialization of the African Americans within their environment,” she said.

The DSME program developed for this study thus focused on family interactions within the African American family in the context of health and nutrition. The curriculum was conceptually based on the family interaction theory, “loose adaptation” of a number of published curricula, and the clinical experiences of the investigators, including a family nurse practitioner, a family psychologist, and a licensed dietitian, Dr. Greene noted.

Four community lay persons and two dietitians were trained to implement the intervention, which included three classes related to diabetes, one on exercise, and four related to nutrition; all classes addressed family interactions, including communication, problem solving, and negotiation skills that would encourage a goal of health behaviors for the entire family.

Patients who participated were over age 40 years (mean of 58.9 years), and had been diagnosed at least 1 year prior to the program. Those in the experimental group were encouraged to select an HFMC who influenced the household diet and other health-related behaviors, and the experimental and control group participants did not differ significantly with respect to any baseline variables.

Classes lasted 1.5 hours each week for 8 weeks, and were held at local community churches; 70% of those in the experimental group and 81% in the control group attended at least six of the eight classes.

The trainers had high “intervention fidelity,” completing the class objectives 90% of the time, and they reported high satisfaction and ease with program implementation. Participants thought the intervention was fun, Dr. Greene said. “Their retention and attendance showed it,” she said, noting that 92% of those enrolled completed the study.

Further, participants consistently rated the program as highly acceptable, either agreeing or strongly agreeing that each class had content that was understandable, useful, and informative, and that the trainer was knowledgeable and the class was interactive.

The program was successful and unique in that it taught participants to think about healthy behaviors and improve communication and negotiation at home, Dr. Greene said.

“We incorporated the family and their interpersonal interactions into the intervention by asking them to think about it and work it out in favor of a healthy change for all,” she said, noting that future studies should investigate sustainability of the program in a larger sample and the possibility of increasing the intervention strength through goal-setting and numerous other measures at the end of each class.

The National Institutes of Health–National Institute on Minority and Health Disparities supported the study.

BOSTON – A family-focused diabetes self-management education program was feasible, well received, and more effective in African American patients with type 2 diabetes who brought along a household family member than among those who participated alone, according to findings from a randomized study.

In 21 participants who were randomized to attend the diabetes self-management education (DSME) program with a household family member or companion (HFMC), and who completed the study, significant reductions were seen at 3 months in body mass index, blood pressure, and cholesterol levels, but the same was not true among 27 participants who attended alone, Natasha Greene, Ph.D., reported at the annual scientific sessions of the American Diabetes Association.

BMI among those who brought an HFMC was reduced from 37.4 to 36.6, while those who attended alone experienced a reduction from 36 to 35.7. Mean systolic blood pressure was reduced from 154.2 mm Hg to 139.5 mm Hg, and from 146.3 mm Hg to 140.2 mm Hg in the groups, respectively. Mean diastolic blood pressure was reduced from 75 mm Hg to 69 mm Hg, and increased from 72.2 mm Hg to 73.5 mm Hg in the groups, respectively, said Dr. Greene of North Carolina Central University, Durham.

Mean total cholesterol was reduced from 175.7 mg/dL to 164.1 mg/dL, and increased from 167.2 mg/dL to 171.3 mg/dL and low density lipoprotein cholesterol was reduced from 106 mg/dL to 96.3 mg/dL, and increased from 95 mg/dL to 99 mg/dL in the groups, respectively, she said, noting that hemoglobin A1c levels improved, but not significantly, in either group.

“DSME interventions have drastically increased over the last 10 years. Most interventions have been successful, but statistically significant outcomes either weakened after 6-12 months or completely disappeared,” Dr. Greene said, adding that it is “therefore essential to develop some interventions that have sustainable outcomes, especially in African Americans.”

African Americans continue to experience higher rates of diabetes prevalence, complications, and premature age-adjusted deaths, compared with non-Hispanic European Americans, she explained.

“Moreover, African Americans report difficulty following recommendations because the regimens interfere with work, family life, beliefs, family food preferences, and the socialization of the African Americans within their environment,” she said.

The DSME program developed for this study thus focused on family interactions within the African American family in the context of health and nutrition. The curriculum was conceptually based on the family interaction theory, “loose adaptation” of a number of published curricula, and the clinical experiences of the investigators, including a family nurse practitioner, a family psychologist, and a licensed dietitian, Dr. Greene noted.

Four community lay persons and two dietitians were trained to implement the intervention, which included three classes related to diabetes, one on exercise, and four related to nutrition; all classes addressed family interactions, including communication, problem solving, and negotiation skills that would encourage a goal of health behaviors for the entire family.

Patients who participated were over age 40 years (mean of 58.9 years), and had been diagnosed at least 1 year prior to the program. Those in the experimental group were encouraged to select an HFMC who influenced the household diet and other health-related behaviors, and the experimental and control group participants did not differ significantly with respect to any baseline variables.

Classes lasted 1.5 hours each week for 8 weeks, and were held at local community churches; 70% of those in the experimental group and 81% in the control group attended at least six of the eight classes.

The trainers had high “intervention fidelity,” completing the class objectives 90% of the time, and they reported high satisfaction and ease with program implementation. Participants thought the intervention was fun, Dr. Greene said. “Their retention and attendance showed it,” she said, noting that 92% of those enrolled completed the study.

Further, participants consistently rated the program as highly acceptable, either agreeing or strongly agreeing that each class had content that was understandable, useful, and informative, and that the trainer was knowledgeable and the class was interactive.

The program was successful and unique in that it taught participants to think about healthy behaviors and improve communication and negotiation at home, Dr. Greene said.

“We incorporated the family and their interpersonal interactions into the intervention by asking them to think about it and work it out in favor of a healthy change for all,” she said, noting that future studies should investigate sustainability of the program in a larger sample and the possibility of increasing the intervention strength through goal-setting and numerous other measures at the end of each class.

The National Institutes of Health–National Institute on Minority and Health Disparities supported the study.

BOSTON – A family-focused diabetes self-management education program was feasible, well received, and more effective in African American patients with type 2 diabetes who brought along a household family member than among those who participated alone, according to findings from a randomized study.

In 21 participants who were randomized to attend the diabetes self-management education (DSME) program with a household family member or companion (HFMC), and who completed the study, significant reductions were seen at 3 months in body mass index, blood pressure, and cholesterol levels, but the same was not true among 27 participants who attended alone, Natasha Greene, Ph.D., reported at the annual scientific sessions of the American Diabetes Association.

BMI among those who brought an HFMC was reduced from 37.4 to 36.6, while those who attended alone experienced a reduction from 36 to 35.7. Mean systolic blood pressure was reduced from 154.2 mm Hg to 139.5 mm Hg, and from 146.3 mm Hg to 140.2 mm Hg in the groups, respectively. Mean diastolic blood pressure was reduced from 75 mm Hg to 69 mm Hg, and increased from 72.2 mm Hg to 73.5 mm Hg in the groups, respectively, said Dr. Greene of North Carolina Central University, Durham.

Mean total cholesterol was reduced from 175.7 mg/dL to 164.1 mg/dL, and increased from 167.2 mg/dL to 171.3 mg/dL and low density lipoprotein cholesterol was reduced from 106 mg/dL to 96.3 mg/dL, and increased from 95 mg/dL to 99 mg/dL in the groups, respectively, she said, noting that hemoglobin A1c levels improved, but not significantly, in either group.

“DSME interventions have drastically increased over the last 10 years. Most interventions have been successful, but statistically significant outcomes either weakened after 6-12 months or completely disappeared,” Dr. Greene said, adding that it is “therefore essential to develop some interventions that have sustainable outcomes, especially in African Americans.”

African Americans continue to experience higher rates of diabetes prevalence, complications, and premature age-adjusted deaths, compared with non-Hispanic European Americans, she explained.

“Moreover, African Americans report difficulty following recommendations because the regimens interfere with work, family life, beliefs, family food preferences, and the socialization of the African Americans within their environment,” she said.

The DSME program developed for this study thus focused on family interactions within the African American family in the context of health and nutrition. The curriculum was conceptually based on the family interaction theory, “loose adaptation” of a number of published curricula, and the clinical experiences of the investigators, including a family nurse practitioner, a family psychologist, and a licensed dietitian, Dr. Greene noted.

Four community lay persons and two dietitians were trained to implement the intervention, which included three classes related to diabetes, one on exercise, and four related to nutrition; all classes addressed family interactions, including communication, problem solving, and negotiation skills that would encourage a goal of health behaviors for the entire family.

Patients who participated were over age 40 years (mean of 58.9 years), and had been diagnosed at least 1 year prior to the program. Those in the experimental group were encouraged to select an HFMC who influenced the household diet and other health-related behaviors, and the experimental and control group participants did not differ significantly with respect to any baseline variables.

Classes lasted 1.5 hours each week for 8 weeks, and were held at local community churches; 70% of those in the experimental group and 81% in the control group attended at least six of the eight classes.

The trainers had high “intervention fidelity,” completing the class objectives 90% of the time, and they reported high satisfaction and ease with program implementation. Participants thought the intervention was fun, Dr. Greene said. “Their retention and attendance showed it,” she said, noting that 92% of those enrolled completed the study.

Further, participants consistently rated the program as highly acceptable, either agreeing or strongly agreeing that each class had content that was understandable, useful, and informative, and that the trainer was knowledgeable and the class was interactive.

The program was successful and unique in that it taught participants to think about healthy behaviors and improve communication and negotiation at home, Dr. Greene said.

“We incorporated the family and their interpersonal interactions into the intervention by asking them to think about it and work it out in favor of a healthy change for all,” she said, noting that future studies should investigate sustainability of the program in a larger sample and the possibility of increasing the intervention strength through goal-setting and numerous other measures at the end of each class.

The National Institutes of Health–National Institute on Minority and Health Disparities supported the study.

BOSTON – A family-focused diabetes self-management education program was feasible, well received, and more effective in African American patients with type 2 diabetes who brought along a household family member than among those who participated alone, according to findings from a randomized study.

In 21 participants who were randomized to attend the diabetes self-management education (DSME) program with a household family member or companion (HFMC), and who completed the study, significant reductions were seen at 3 months in body mass index, blood pressure, and cholesterol levels, but the same was not true among 27 participants who attended alone, Natasha Greene, Ph.D., reported at the annual scientific sessions of the American Diabetes Association.

BMI among those who brought an HFMC was reduced from 37.4 to 36.6, while those who attended alone experienced a reduction from 36 to 35.7. Mean systolic blood pressure was reduced from 154.2 mm Hg to 139.5 mm Hg, and from 146.3 mm Hg to 140.2 mm Hg in the groups, respectively. Mean diastolic blood pressure was reduced from 75 mm Hg to 69 mm Hg, and increased from 72.2 mm Hg to 73.5 mm Hg in the groups, respectively, said Dr. Greene of North Carolina Central University, Durham.

Mean total cholesterol was reduced from 175.7 mg/dL to 164.1 mg/dL, and increased from 167.2 mg/dL to 171.3 mg/dL and low density lipoprotein cholesterol was reduced from 106 mg/dL to 96.3 mg/dL, and increased from 95 mg/dL to 99 mg/dL in the groups, respectively, she said, noting that hemoglobin A1c levels improved, but not significantly, in either group.

“DSME interventions have drastically increased over the last 10 years. Most interventions have been successful, but statistically significant outcomes either weakened after 6-12 months or completely disappeared,” Dr. Greene said, adding that it is “therefore essential to develop some interventions that have sustainable outcomes, especially in African Americans.”

African Americans continue to experience higher rates of diabetes prevalence, complications, and premature age-adjusted deaths, compared with non-Hispanic European Americans, she explained.

“Moreover, African Americans report difficulty following recommendations because the regimens interfere with work, family life, beliefs, family food preferences, and the socialization of the African Americans within their environment,” she said.

The DSME program developed for this study thus focused on family interactions within the African American family in the context of health and nutrition. The curriculum was conceptually based on the family interaction theory, “loose adaptation” of a number of published curricula, and the clinical experiences of the investigators, including a family nurse practitioner, a family psychologist, and a licensed dietitian, Dr. Greene noted.

Four community lay persons and two dietitians were trained to implement the intervention, which included three classes related to diabetes, one on exercise, and four related to nutrition; all classes addressed family interactions, including communication, problem solving, and negotiation skills that would encourage a goal of health behaviors for the entire family.

Patients who participated were over age 40 years (mean of 58.9 years), and had been diagnosed at least 1 year prior to the program. Those in the experimental group were encouraged to select an HFMC who influenced the household diet and other health-related behaviors, and the experimental and control group participants did not differ significantly with respect to any baseline variables.

Classes lasted 1.5 hours each week for 8 weeks, and were held at local community churches; 70% of those in the experimental group and 81% in the control group attended at least six of the eight classes.

The trainers had high “intervention fidelity,” completing the class objectives 90% of the time, and they reported high satisfaction and ease with program implementation. Participants thought the intervention was fun, Dr. Greene said. “Their retention and attendance showed it,” she said, noting that 92% of those enrolled completed the study.

Further, participants consistently rated the program as highly acceptable, either agreeing or strongly agreeing that each class had content that was understandable, useful, and informative, and that the trainer was knowledgeable and the class was interactive.

The program was successful and unique in that it taught participants to think about healthy behaviors and improve communication and negotiation at home, Dr. Greene said.

“We incorporated the family and their interpersonal interactions into the intervention by asking them to think about it and work it out in favor of a healthy change for all,” she said, noting that future studies should investigate sustainability of the program in a larger sample and the possibility of increasing the intervention strength through goal-setting and numerous other measures at the end of each class.

The National Institutes of Health–National Institute on Minority and Health Disparities supported the study.

sworcester@frontlinemedcom.com

BOSTON – A family-focused diabetes self-management education program was feasible, well received, and more effective in African American patients with type 2 diabetes who brought along a household family member than among those who participated alone, according to findings from a randomized study.

In 21 participants who were randomized to attend the diabetes self-management education (DSME) program with a household family member or companion (HFMC), and who completed the study, significant reductions were seen at 3 months in body mass index, blood pressure, and cholesterol levels, but the same was not true among 27 participants who attended alone, Natasha Greene, Ph.D., reported at the annual scientific sessions of the American Diabetes Association.

BMI among those who brought an HFMC was reduced from 37.4 to 36.6, while those who attended alone experienced a reduction from 36 to 35.7. Mean systolic blood pressure was reduced from 154.2 mm Hg to 139.5 mm Hg, and from 146.3 mm Hg to 140.2 mm Hg in the groups, respectively. Mean diastolic blood pressure was reduced from 75 mm Hg to 69 mm Hg, and increased from 72.2 mm Hg to 73.5 mm Hg in the groups, respectively, said Dr. Greene of North Carolina Central University, Durham.

Mean total cholesterol was reduced from 175.7 mg/dL to 164.1 mg/dL, and increased from 167.2 mg/dL to 171.3 mg/dL and low density lipoprotein cholesterol was reduced from 106 mg/dL to 96.3 mg/dL, and increased from 95 mg/dL to 99 mg/dL in the groups, respectively, she said, noting that hemoglobin A1c levels improved, but not significantly, in either group.

“DSME interventions have drastically increased over the last 10 years. Most interventions have been successful, but statistically significant outcomes either weakened after 6-12 months or completely disappeared,” Dr. Greene said, adding that it is “therefore essential to develop some interventions that have sustainable outcomes, especially in African Americans.”

African Americans continue to experience higher rates of diabetes prevalence, complications, and premature age-adjusted deaths, compared with non-Hispanic European Americans, she explained.

“Moreover, African Americans report difficulty following recommendations because the regimens interfere with work, family life, beliefs, family food preferences, and the socialization of the African Americans within their environment,” she said.

The DSME program developed for this study thus focused on family interactions within the African American family in the context of health and nutrition. The curriculum was conceptually based on the family interaction theory, “loose adaptation” of a number of published curricula, and the clinical experiences of the investigators, including a family nurse practitioner, a family psychologist, and a licensed dietitian, Dr. Greene noted.

Four community lay persons and two dietitians were trained to implement the intervention, which included three classes related to diabetes, one on exercise, and four related to nutrition; all classes addressed family interactions, including communication, problem solving, and negotiation skills that would encourage a goal of health behaviors for the entire family.

Patients who participated were over age 40 years (mean of 58.9 years), and had been diagnosed at least 1 year prior to the program. Those in the experimental group were encouraged to select an HFMC who influenced the household diet and other health-related behaviors, and the experimental and control group participants did not differ significantly with respect to any baseline variables.

Classes lasted 1.5 hours each week for 8 weeks, and were held at local community churches; 70% of those in the experimental group and 81% in the control group attended at least six of the eight classes.

The trainers had high “intervention fidelity,” completing the class objectives 90% of the time, and they reported high satisfaction and ease with program implementation. Participants thought the intervention was fun, Dr. Greene said. “Their retention and attendance showed it,” she said, noting that 92% of those enrolled completed the study.

Further, participants consistently rated the program as highly acceptable, either agreeing or strongly agreeing that each class had content that was understandable, useful, and informative, and that the trainer was knowledgeable and the class was interactive.

The program was successful and unique in that it taught participants to think about healthy behaviors and improve communication and negotiation at home, Dr. Greene said.

“We incorporated the family and their interpersonal interactions into the intervention by asking them to think about it and work it out in favor of a healthy change for all,” she said, noting that future studies should investigate sustainability of the program in a larger sample and the possibility of increasing the intervention strength through goal-setting and numerous other measures at the end of each class.

The National Institutes of Health–National Institute on Minority and Health Disparities supported the study.

sworcester@frontlinemedcom.com

BOSTON – A family-focused diabetes self-management education program was feasible, well received, and more effective in African American patients with type 2 diabetes who brought along a household family member than among those who participated alone, according to findings from a randomized study.

In 21 participants who were randomized to attend the diabetes self-management education (DSME) program with a household family member or companion (HFMC), and who completed the study, significant reductions were seen at 3 months in body mass index, blood pressure, and cholesterol levels, but the same was not true among 27 participants who attended alone, Natasha Greene, Ph.D., reported at the annual scientific sessions of the American Diabetes Association.

BMI among those who brought an HFMC was reduced from 37.4 to 36.6, while those who attended alone experienced a reduction from 36 to 35.7. Mean systolic blood pressure was reduced from 154.2 mm Hg to 139.5 mm Hg, and from 146.3 mm Hg to 140.2 mm Hg in the groups, respectively. Mean diastolic blood pressure was reduced from 75 mm Hg to 69 mm Hg, and increased from 72.2 mm Hg to 73.5 mm Hg in the groups, respectively, said Dr. Greene of North Carolina Central University, Durham.

Mean total cholesterol was reduced from 175.7 mg/dL to 164.1 mg/dL, and increased from 167.2 mg/dL to 171.3 mg/dL and low density lipoprotein cholesterol was reduced from 106 mg/dL to 96.3 mg/dL, and increased from 95 mg/dL to 99 mg/dL in the groups, respectively, she said, noting that hemoglobin A1c levels improved, but not significantly, in either group.

“DSME interventions have drastically increased over the last 10 years. Most interventions have been successful, but statistically significant outcomes either weakened after 6-12 months or completely disappeared,” Dr. Greene said, adding that it is “therefore essential to develop some interventions that have sustainable outcomes, especially in African Americans.”

African Americans continue to experience higher rates of diabetes prevalence, complications, and premature age-adjusted deaths, compared with non-Hispanic European Americans, she explained.

“Moreover, African Americans report difficulty following recommendations because the regimens interfere with work, family life, beliefs, family food preferences, and the socialization of the African Americans within their environment,” she said.

The DSME program developed for this study thus focused on family interactions within the African American family in the context of health and nutrition. The curriculum was conceptually based on the family interaction theory, “loose adaptation” of a number of published curricula, and the clinical experiences of the investigators, including a family nurse practitioner, a family psychologist, and a licensed dietitian, Dr. Greene noted.

Four community lay persons and two dietitians were trained to implement the intervention, which included three classes related to diabetes, one on exercise, and four related to nutrition; all classes addressed family interactions, including communication, problem solving, and negotiation skills that would encourage a goal of health behaviors for the entire family.

Patients who participated were over age 40 years (mean of 58.9 years), and had been diagnosed at least 1 year prior to the program. Those in the experimental group were encouraged to select an HFMC who influenced the household diet and other health-related behaviors, and the experimental and control group participants did not differ significantly with respect to any baseline variables.

Classes lasted 1.5 hours each week for 8 weeks, and were held at local community churches; 70% of those in the experimental group and 81% in the control group attended at least six of the eight classes.

The trainers had high “intervention fidelity,” completing the class objectives 90% of the time, and they reported high satisfaction and ease with program implementation. Participants thought the intervention was fun, Dr. Greene said. “Their retention and attendance showed it,” she said, noting that 92% of those enrolled completed the study.

Further, participants consistently rated the program as highly acceptable, either agreeing or strongly agreeing that each class had content that was understandable, useful, and informative, and that the trainer was knowledgeable and the class was interactive.

The program was successful and unique in that it taught participants to think about healthy behaviors and improve communication and negotiation at home, Dr. Greene said.

“We incorporated the family and their interpersonal interactions into the intervention by asking them to think about it and work it out in favor of a healthy change for all,” she said, noting that future studies should investigate sustainability of the program in a larger sample and the possibility of increasing the intervention strength through goal-setting and numerous other measures at the end of each class.

The National Institutes of Health–National Institute on Minority and Health Disparities supported the study.

sworcester@frontlinemedcom.com

BOSTON – Adding a dipeptidyl peptidase-4 (DPP-4) inhibitor to metformin in patients with type 2 diabetes was associated with an increased, earlier need for treatment intensification, compared with adding a sulfonylurea in a large, retrospective, population-based study in the United Kingdom.

Conversely, adding a thiazolidinedione as a second-line glucose-lowering agent resulted in the most durable glycemic response, Jil Mamza reported at the annual scientific sessions of the American Diabetes Association.

Unadjusted survival analysis showed that 23% of 3,080 patients treated with second-line DDP-4 agents experienced treatment failure at 1 year, compared with 15% of 15,508 on a sulfonylurea, and 8% of 1,582 on a thiazolidinedione. The corresponding failure rates at 2 years were 38%, 26% and 12%, said Mr. Mamza, a clinical researcher and doctoral student at the University of Nottingham, Derby, England.

After multivariate adjustment, adding a DPP-4 inhibitor was associated with an increased hazard of intensification of therapy (adjusted hazard ratio, 1.58), while adding a thiazolidinedione was associated with a reduced hazard (adjusted HR, 0.45).

Several baseline factors were also shown to be associated an increased hazard of intensification, including hemoglobin A_1c level, diabetes duration, gender, smoking status, and the use of lipid-lowering medications, he said.

Patients included in this study were adults with a mean age of 60 years and a mean disease duration of 3 years from the The Health Initiative Network (THIN) database of United Kingdom general practice patients. All those included had added a second oral glucose lowering therapy (GLT) to metformin between 2007 and 2014.

Time to dual therapy failure was defined as time to treatment substitution or intensification with a third agent at an HbA_1c level greater than 58 mmol/mol.

The durability of glycemic response for different second-line treatments was previously unclear. These findings suggest that DPP-4 agents provide the least durable response, compared with sulfonylureas and thiazolidinediones as second-line GLTs, Dr. Mamza said.

Mr. Mamza reported having no disclosures.

sworcester@frontlinemedcom.com

BOSTON – Adding a dipeptidyl peptidase-4 (DPP-4) inhibitor to metformin in patients with type 2 diabetes was associated with an increased, earlier need for treatment intensification, compared with adding a sulfonylurea in a large, retrospective, population-based study in the United Kingdom.

Conversely, adding a thiazolidinedione as a second-line glucose-lowering agent resulted in the most durable glycemic response, Jil Mamza reported at the annual scientific sessions of the American Diabetes Association.

Unadjusted survival analysis showed that 23% of 3,080 patients treated with second-line DDP-4 agents experienced treatment failure at 1 year, compared with 15% of 15,508 on a sulfonylurea, and 8% of 1,582 on a thiazolidinedione. The corresponding failure rates at 2 years were 38%, 26% and 12%, said Mr. Mamza, a clinical researcher and doctoral student at the University of Nottingham, Derby, England.

After multivariate adjustment, adding a DPP-4 inhibitor was associated with an increased hazard of intensification of therapy (adjusted hazard ratio, 1.58), while adding a thiazolidinedione was associated with a reduced hazard (adjusted HR, 0.45).

Several baseline factors were also shown to be associated an increased hazard of intensification, including hemoglobin A_1c level, diabetes duration, gender, smoking status, and the use of lipid-lowering medications, he said.

Patients included in this study were adults with a mean age of 60 years and a mean disease duration of 3 years from the The Health Initiative Network (THIN) database of United Kingdom general practice patients. All those included had added a second oral glucose lowering therapy (GLT) to metformin between 2007 and 2014.

Time to dual therapy failure was defined as time to treatment substitution or intensification with a third agent at an HbA_1c level greater than 58 mmol/mol.

The durability of glycemic response for different second-line treatments was previously unclear. These findings suggest that DPP-4 agents provide the least durable response, compared with sulfonylureas and thiazolidinediones as second-line GLTs, Dr. Mamza said.

Mr. Mamza reported having no disclosures.

sworcester@frontlinemedcom.com

BOSTON – Adding a dipeptidyl peptidase-4 (DPP-4) inhibitor to metformin in patients with type 2 diabetes was associated with an increased, earlier need for treatment intensification, compared with adding a sulfonylurea in a large, retrospective, population-based study in the United Kingdom.

Conversely, adding a thiazolidinedione as a second-line glucose-lowering agent resulted in the most durable glycemic response, Jil Mamza reported at the annual scientific sessions of the American Diabetes Association.

Unadjusted survival analysis showed that 23% of 3,080 patients treated with second-line DDP-4 agents experienced treatment failure at 1 year, compared with 15% of 15,508 on a sulfonylurea, and 8% of 1,582 on a thiazolidinedione. The corresponding failure rates at 2 years were 38%, 26% and 12%, said Mr. Mamza, a clinical researcher and doctoral student at the University of Nottingham, Derby, England.

After multivariate adjustment, adding a DPP-4 inhibitor was associated with an increased hazard of intensification of therapy (adjusted hazard ratio, 1.58), while adding a thiazolidinedione was associated with a reduced hazard (adjusted HR, 0.45).

Several baseline factors were also shown to be associated an increased hazard of intensification, including hemoglobin A_1c level, diabetes duration, gender, smoking status, and the use of lipid-lowering medications, he said.

Patients included in this study were adults with a mean age of 60 years and a mean disease duration of 3 years from the The Health Initiative Network (THIN) database of United Kingdom general practice patients. All those included had added a second oral glucose lowering therapy (GLT) to metformin between 2007 and 2014.

Time to dual therapy failure was defined as time to treatment substitution or intensification with a third agent at an HbA_1c level greater than 58 mmol/mol.

The durability of glycemic response for different second-line treatments was previously unclear. These findings suggest that DPP-4 agents provide the least durable response, compared with sulfonylureas and thiazolidinediones as second-line GLTs, Dr. Mamza said.

Mr. Mamza reported having no disclosures.

sworcester@frontlinemedcom.com

BOSTON – Maintaining or improving cardiorespiratory fitness during the year following an intensive lifestyle intervention contributed to the prevention of advanced chronic kidney disease over 4 years among participants in Look AHEAD, according to findings from a substudy of that randomized clinical trial.

During the first 4 years of follow-up in 4,906 of the 5,145 original study subjects, the incidence of advanced chronic kidney disease – after adjustment for age, race, ethnicity, and disease-related baseline covariates – was reduced by nearly 60% in those who received the intervention in the original study, compared with those who received diabetes support and education (hazard ratio, 0.59), Dr. Margareta I. Hellgren reported at the annual scientific sessions of the American Diabetes Association.

At 1-year follow-up, fitness level was unchanged in 77% of the lifestyle intervention group patients, compared with 58% of those in the diabetes support and education group, and in a model that used the same covariates, plus 1-year fitness change, and which included annually updated weight, blood pressure, and hemoglobin A1c, both intervention group participation and unchanged or improved fitness predicted lower incidence of advanced CKD over 4 years (HR, 0.69, 0.49, respectively), said Dr. Hellgren of the University of Gothenburg, Sweden.

The multicenter Look AHEAD trial included overweight adults with type 2 diabetes who were followed for about 10 years. The findings, which were published in 2013, showed no difference between intensive lifestyle intervention – including physical activity and reduced calorie intake – and diabetes support and education for reducing the incidence of cardiovascular events (the primary outcome measure), but did demonstrate a benefit with intensive lifestyle intervention for a number of secondary outcomes, including nephropathy.

A secondary analysis published in The Lancet in 2014 showed that the incidence of advanced kidney disease was reduced by 31% over 8 years in those in the intervention group, compared with those in the diabetes care and intervention group – an effect that was partly attributable to reductions in body weight, HbA1c, and systolic blood pressure, she noted.

The outcome of the current substudy was very high risk kidney disease (classified according to the Kidney Disease Improving Global Outcomes Guidelines), which is an important cause of disability and high costs and is associated with high mortality, Dr. Hellgren said.

Study subjects had a mean age of 58.6 years at baseline, 59% were women, and 66% were non-Hispanic whites. Known diabetes duration was 6.7 years.

Fitness assessment was based on estimated metabolic equivalents (METs) during a graded treadmill exercise test at baseline and at 1 year. A significant association was seen between baseline fitness and class of chronic kidney disease, Dr. Hellgren said, noting that 31% of those with the lowest fitness level had abnormal kidney function, compared with 14% of those with the highest level.

“Physical fitness at baseline was positively associated with kidney function. Maintaining or improving fitness during the first year was associated with lower incidence of very high risk kidney disease in both intervention groups, with a 51% reduction overall,” she said, adding that the lifestyle intervention effect was only partially attenuated after accounting for fitness change and annually updated wight, blood pressure, and HbA1c, which suggests that an additional unknown mechanism is responsible for the benefits of intervention.

The National Institute of Diabetes and Digestive and Kidney Diseases sponsored Look AHEAD. Dr. Hellgren reported having no disclosures.

sworcester@frontlinemedcom.com

BOSTON – Maintaining or improving cardiorespiratory fitness during the year following an intensive lifestyle intervention contributed to the prevention of advanced chronic kidney disease over 4 years among participants in Look AHEAD, according to findings from a substudy of that randomized clinical trial.

During the first 4 years of follow-up in 4,906 of the 5,145 original study subjects, the incidence of advanced chronic kidney disease – after adjustment for age, race, ethnicity, and disease-related baseline covariates – was reduced by nearly 60% in those who received the intervention in the original study, compared with those who received diabetes support and education (hazard ratio, 0.59), Dr. Margareta I. Hellgren reported at the annual scientific sessions of the American Diabetes Association.

At 1-year follow-up, fitness level was unchanged in 77% of the lifestyle intervention group patients, compared with 58% of those in the diabetes support and education group, and in a model that used the same covariates, plus 1-year fitness change, and which included annually updated weight, blood pressure, and hemoglobin A1c, both intervention group participation and unchanged or improved fitness predicted lower incidence of advanced CKD over 4 years (HR, 0.69, 0.49, respectively), said Dr. Hellgren of the University of Gothenburg, Sweden.

The multicenter Look AHEAD trial included overweight adults with type 2 diabetes who were followed for about 10 years. The findings, which were published in 2013, showed no difference between intensive lifestyle intervention – including physical activity and reduced calorie intake – and diabetes support and education for reducing the incidence of cardiovascular events (the primary outcome measure), but did demonstrate a benefit with intensive lifestyle intervention for a number of secondary outcomes, including nephropathy.

A secondary analysis published in The Lancet in 2014 showed that the incidence of advanced kidney disease was reduced by 31% over 8 years in those in the intervention group, compared with those in the diabetes care and intervention group – an effect that was partly attributable to reductions in body weight, HbA1c, and systolic blood pressure, she noted.

The outcome of the current substudy was very high risk kidney disease (classified according to the Kidney Disease Improving Global Outcomes Guidelines), which is an important cause of disability and high costs and is associated with high mortality, Dr. Hellgren said.

Study subjects had a mean age of 58.6 years at baseline, 59% were women, and 66% were non-Hispanic whites. Known diabetes duration was 6.7 years.

Fitness assessment was based on estimated metabolic equivalents (METs) during a graded treadmill exercise test at baseline and at 1 year. A significant association was seen between baseline fitness and class of chronic kidney disease, Dr. Hellgren said, noting that 31% of those with the lowest fitness level had abnormal kidney function, compared with 14% of those with the highest level.

“Physical fitness at baseline was positively associated with kidney function. Maintaining or improving fitness during the first year was associated with lower incidence of very high risk kidney disease in both intervention groups, with a 51% reduction overall,” she said, adding that the lifestyle intervention effect was only partially attenuated after accounting for fitness change and annually updated wight, blood pressure, and HbA1c, which suggests that an additional unknown mechanism is responsible for the benefits of intervention.

The National Institute of Diabetes and Digestive and Kidney Diseases sponsored Look AHEAD. Dr. Hellgren reported having no disclosures.

sworcester@frontlinemedcom.com

BOSTON – Maintaining or improving cardiorespiratory fitness during the year following an intensive lifestyle intervention contributed to the prevention of advanced chronic kidney disease over 4 years among participants in Look AHEAD, according to findings from a substudy of that randomized clinical trial.

During the first 4 years of follow-up in 4,906 of the 5,145 original study subjects, the incidence of advanced chronic kidney disease – after adjustment for age, race, ethnicity, and disease-related baseline covariates – was reduced by nearly 60% in those who received the intervention in the original study, compared with those who received diabetes support and education (hazard ratio, 0.59), Dr. Margareta I. Hellgren reported at the annual scientific sessions of the American Diabetes Association.

At 1-year follow-up, fitness level was unchanged in 77% of the lifestyle intervention group patients, compared with 58% of those in the diabetes support and education group, and in a model that used the same covariates, plus 1-year fitness change, and which included annually updated weight, blood pressure, and hemoglobin A1c, both intervention group participation and unchanged or improved fitness predicted lower incidence of advanced CKD over 4 years (HR, 0.69, 0.49, respectively), said Dr. Hellgren of the University of Gothenburg, Sweden.

The multicenter Look AHEAD trial included overweight adults with type 2 diabetes who were followed for about 10 years. The findings, which were published in 2013, showed no difference between intensive lifestyle intervention – including physical activity and reduced calorie intake – and diabetes support and education for reducing the incidence of cardiovascular events (the primary outcome measure), but did demonstrate a benefit with intensive lifestyle intervention for a number of secondary outcomes, including nephropathy.

A secondary analysis published in The Lancet in 2014 showed that the incidence of advanced kidney disease was reduced by 31% over 8 years in those in the intervention group, compared with those in the diabetes care and intervention group – an effect that was partly attributable to reductions in body weight, HbA1c, and systolic blood pressure, she noted.

The outcome of the current substudy was very high risk kidney disease (classified according to the Kidney Disease Improving Global Outcomes Guidelines), which is an important cause of disability and high costs and is associated with high mortality, Dr. Hellgren said.

Study subjects had a mean age of 58.6 years at baseline, 59% were women, and 66% were non-Hispanic whites. Known diabetes duration was 6.7 years.

Fitness assessment was based on estimated metabolic equivalents (METs) during a graded treadmill exercise test at baseline and at 1 year. A significant association was seen between baseline fitness and class of chronic kidney disease, Dr. Hellgren said, noting that 31% of those with the lowest fitness level had abnormal kidney function, compared with 14% of those with the highest level.

“Physical fitness at baseline was positively associated with kidney function. Maintaining or improving fitness during the first year was associated with lower incidence of very high risk kidney disease in both intervention groups, with a 51% reduction overall,” she said, adding that the lifestyle intervention effect was only partially attenuated after accounting for fitness change and annually updated wight, blood pressure, and HbA1c, which suggests that an additional unknown mechanism is responsible for the benefits of intervention.

The National Institute of Diabetes and Digestive and Kidney Diseases sponsored Look AHEAD. Dr. Hellgren reported having no disclosures.

sworcester@frontlinemedcom.com

BOSTON – Psychosocial stress is an independent risk factor for excess weight gain among women with gestational diabetes mellitus, findings from the Gestational Diabetes Effects on Moms (GEM) study suggest.

Among nearly 1,300 women in the cluster randomized trial conducted within Kaiser Permanent Northern California, perceived stress near the time of gestational diabetes diagnosis at around 32 weeks’ gestation was significantly associated with a risk of excess gestational weight gain.

After adjusting for gestational and maternal age at the time of gestational diabetes diagnosis, education level, pregravid body mass index, and race/ethnicity, an upper-quartile score on the Perceived Stress Scale (PSS), compared with a lower score, was associated with a 54% increased odds of weight gain that exceeded Institute of Medicine recommendations (odds ratio, 1.54), Ai Kubo, Ph.D., of Kaiser Permanente in Oakland, Calif., reported at the annual scientific sessions of the American Diabetes Association.

A significant trend between PSS score and gestational weight gain was seen, and the association was not attenuated by inclusion of other lifestyle variables, including diet and physical activity, Dr. Kubo said, noting that no association was seen between PSS and the odds of gaining weight at a level below the IOM recommendations.

Dr. Kubo and her colleagues examined the relationship between stress and weight gain using baseline data from the GEM study. Subjects were women who delivered a term singleton at greater than 37 weeks’ gestation. Total gestational weight gain (about 20 pounds on average) and prepregnancy body mass index were obtained from electronic health records. Weight gain was categorized according to 2009 IOM recommendations.

Women with lower socioeconomic status tended to be in the highest stress group, and although there was no significant differences in prepregnancy weight between the highest and lowest stress groups, more of those with BMIs over 35 were in the highest stress group, she noted.

“Excess gestational weight gain has become an important public health concern,” Dr. Kubo said, noting that nearly 60% of women exceed IOM recommendations for weight gain, which increases the risk of adverse health outcomes, including obesity, in both women and their offspring.

Gestational diabetes mellitus occurs in about 8% of all pregnant women and also increases the risk of adverse outcomes in both mothers and offspring, she said.

The current findings suggest that stress reduction interventions may be warranted in women with gestational diabetes mellitus to optimize weight gain and possibly reduce the risks to both mother and offspring, she said, noting that the study is limited by a lack of assessment regarding the timing of stress relative to weight gain and gestational diabetes diagnosis.

“For future studies, use of a [non–gestational diabetes] population, and assessment of stress at the beginning of the pregnancy or even prior to the pregnancy would help us better understand the role of psychosocial stress on weight gain during pregnancy,” she said.

Dr. Kubo reported having no disclosures.

sworcester@frontlinemedcom.com

BOSTON – Psychosocial stress is an independent risk factor for excess weight gain among women with gestational diabetes mellitus, findings from the Gestational Diabetes Effects on Moms (GEM) study suggest.

Among nearly 1,300 women in the cluster randomized trial conducted within Kaiser Permanent Northern California, perceived stress near the time of gestational diabetes diagnosis at around 32 weeks’ gestation was significantly associated with a risk of excess gestational weight gain.

After adjusting for gestational and maternal age at the time of gestational diabetes diagnosis, education level, pregravid body mass index, and race/ethnicity, an upper-quartile score on the Perceived Stress Scale (PSS), compared with a lower score, was associated with a 54% increased odds of weight gain that exceeded Institute of Medicine recommendations (odds ratio, 1.54), Ai Kubo, Ph.D., of Kaiser Permanente in Oakland, Calif., reported at the annual scientific sessions of the American Diabetes Association.

A significant trend between PSS score and gestational weight gain was seen, and the association was not attenuated by inclusion of other lifestyle variables, including diet and physical activity, Dr. Kubo said, noting that no association was seen between PSS and the odds of gaining weight at a level below the IOM recommendations.

Dr. Kubo and her colleagues examined the relationship between stress and weight gain using baseline data from the GEM study. Subjects were women who delivered a term singleton at greater than 37 weeks’ gestation. Total gestational weight gain (about 20 pounds on average) and prepregnancy body mass index were obtained from electronic health records. Weight gain was categorized according to 2009 IOM recommendations.

Women with lower socioeconomic status tended to be in the highest stress group, and although there was no significant differences in prepregnancy weight between the highest and lowest stress groups, more of those with BMIs over 35 were in the highest stress group, she noted.

“Excess gestational weight gain has become an important public health concern,” Dr. Kubo said, noting that nearly 60% of women exceed IOM recommendations for weight gain, which increases the risk of adverse health outcomes, including obesity, in both women and their offspring.

Gestational diabetes mellitus occurs in about 8% of all pregnant women and also increases the risk of adverse outcomes in both mothers and offspring, she said.

The current findings suggest that stress reduction interventions may be warranted in women with gestational diabetes mellitus to optimize weight gain and possibly reduce the risks to both mother and offspring, she said, noting that the study is limited by a lack of assessment regarding the timing of stress relative to weight gain and gestational diabetes diagnosis.

“For future studies, use of a [non–gestational diabetes] population, and assessment of stress at the beginning of the pregnancy or even prior to the pregnancy would help us better understand the role of psychosocial stress on weight gain during pregnancy,” she said.

Dr. Kubo reported having no disclosures.

sworcester@frontlinemedcom.com

BOSTON – Psychosocial stress is an independent risk factor for excess weight gain among women with gestational diabetes mellitus, findings from the Gestational Diabetes Effects on Moms (GEM) study suggest.

Among nearly 1,300 women in the cluster randomized trial conducted within Kaiser Permanent Northern California, perceived stress near the time of gestational diabetes diagnosis at around 32 weeks’ gestation was significantly associated with a risk of excess gestational weight gain.

After adjusting for gestational and maternal age at the time of gestational diabetes diagnosis, education level, pregravid body mass index, and race/ethnicity, an upper-quartile score on the Perceived Stress Scale (PSS), compared with a lower score, was associated with a 54% increased odds of weight gain that exceeded Institute of Medicine recommendations (odds ratio, 1.54), Ai Kubo, Ph.D., of Kaiser Permanente in Oakland, Calif., reported at the annual scientific sessions of the American Diabetes Association.

A significant trend between PSS score and gestational weight gain was seen, and the association was not attenuated by inclusion of other lifestyle variables, including diet and physical activity, Dr. Kubo said, noting that no association was seen between PSS and the odds of gaining weight at a level below the IOM recommendations.

Dr. Kubo and her colleagues examined the relationship between stress and weight gain using baseline data from the GEM study. Subjects were women who delivered a term singleton at greater than 37 weeks’ gestation. Total gestational weight gain (about 20 pounds on average) and prepregnancy body mass index were obtained from electronic health records. Weight gain was categorized according to 2009 IOM recommendations.

Women with lower socioeconomic status tended to be in the highest stress group, and although there was no significant differences in prepregnancy weight between the highest and lowest stress groups, more of those with BMIs over 35 were in the highest stress group, she noted.

“Excess gestational weight gain has become an important public health concern,” Dr. Kubo said, noting that nearly 60% of women exceed IOM recommendations for weight gain, which increases the risk of adverse health outcomes, including obesity, in both women and their offspring.

Gestational diabetes mellitus occurs in about 8% of all pregnant women and also increases the risk of adverse outcomes in both mothers and offspring, she said.

The current findings suggest that stress reduction interventions may be warranted in women with gestational diabetes mellitus to optimize weight gain and possibly reduce the risks to both mother and offspring, she said, noting that the study is limited by a lack of assessment regarding the timing of stress relative to weight gain and gestational diabetes diagnosis.

“For future studies, use of a [non–gestational diabetes] population, and assessment of stress at the beginning of the pregnancy or even prior to the pregnancy would help us better understand the role of psychosocial stress on weight gain during pregnancy,” she said.

Dr. Kubo reported having no disclosures.

sworcester@frontlinemedcom.com

BOSTON – Most children diagnosed with type 1 diabetes who develop celiac disease test positive for celiac autoimmunity at the time of their first screen; thus annual rescreening is necessary only in those with a positive first screen and in those who develop celiac disease symptoms, findings from a retrospective records review suggest.

Of 758 children with new-onset type 1 diabetes between August 2007 and March 2012, 69 had celiac autoimmunity, and 96.1% of those were already positive on their first screen, Dr. Rebecca L. Schaub, a pediatric endocrinologist in San Antonio, Texas, reported at the annual scientific sessions of the American Diabetes Association.

Of the children with celiac autoimmunity, 28 underwent small bowel biopsy. Biopsy was strongly recommended in 12 others, but their families refused; some families elected to initiate a gluten-free diet without a biopsy. In children with only minor elevations in titer levels, physicians did not recommend biopsy, Dr. Schaub said.

The probability of biopsy being performed became more likely with increasing tissue transglutaminase (tTG) antibody titers levels, but age, race/ethnicity, and sex did not significantly affect the likelihood of biopsy, she noted.

Celiac disease was diagnosed in 15 children (2% of the overall study population, which is lower than in some other studies), including 54% of those who underwent small bowel biopsy, and 21% of those with celiac autoimmunity.

Only one child who was seronegative at diagnosis later tested positive for celiac autoimmunity and celiac disease on repeat testing, Dr. Schaub said, noting that celiac disease occurred significantly more often in non-Hispanic white children (2.9%), than in Hispanic children (0.7%) or African American children (0%).

Of note, those with autoimmunity had lower body mass index, compared with those without celiac autoimmunity – a finding that did not change when those with celiac disease were excluded from the analysis, said Dr. Schaub.

On multivariate analysis, only tTG levels and race/ethnicity were independent predictors of celiac disease.

A little more than a third (34.8%) of those with celiac autoimmunity at onset of type 1 diabetes became seronegative at 18 months. Many of those patients had very mildly elevated titers, Dr. Schaub said.

The age at onset of type 1 diabetes among the children included in the study was 9.8 years (range of 6 months to 18 years; 61% were between ages 7 and 11 years), and most (58.6%) were non-Hispanic white children, 20.9% were Hispanic, 15.6% were African American, 3.9% were Asian, and 3.7% were mixed race.

Most of the children (95%) underwent tTG immunoglobulin A testing (or tTG immunoglobulin G testing if IgA was deficient) within 3 months of diabetes onset. Repeat screens were conducted in 35.6% of the children; 270 had follow-up screens at more than 18 months after diabetes diagnosis, and 70 had a repeat screens at 36 months or more after diagnosis.

Celiac disease is known to occur more often in patients with type 1 diabetes, Dr. Schaub said, explaining that reported incidence ranges from 1% to 10%, compared with 0.3% to 1% in the general population.

Untreated celiac disease can result in poor growth, difficult glycemic control – including problematic hyperglycemia – and long-term complications including an increased risk of intestinal lymphoproliferative disorder, she said.

A recent paper in Diabetes Care showed that celiac disease is an independent risk factor for the development of nephropathy and retinopathy in patients with type 1 diabetes, she added.

However, current guidelines are inconsistent. For example, current ADA guidelines call for screening at diagnosis, but they state that the effectiveness and optimal frequency of repeat screening remains unclear in asymptomatic patients; some others recommend screening at diagnosis, and repeat screening every 1-2 years thereafter.

The findings suggest that while some children without celiac autoimmunity at the time of type 1 diabetes diagnosis may require annual rescreening, such rescreening “might not be a good use of resources” in those who are asymptomatic, she said, noting that race, tTG titers, and some other factors such as genetics might play a role in recommendations for biopsy.

Also, the findings of lower BMI in children with celiac autoimmunity “certainly warrant further investigation,” she concluded.

Dr. Schaub reported having no disclosures.

BOSTON – Most children diagnosed with type 1 diabetes who develop celiac disease test positive for celiac autoimmunity at the time of their first screen; thus annual rescreening is necessary only in those with a positive first screen and in those who develop celiac disease symptoms, findings from a retrospective records review suggest.

Of 758 children with new-onset type 1 diabetes between August 2007 and March 2012, 69 had celiac autoimmunity, and 96.1% of those were already positive on their first screen, Dr. Rebecca L. Schaub, a pediatric endocrinologist in San Antonio, Texas, reported at the annual scientific sessions of the American Diabetes Association.

Of the children with celiac autoimmunity, 28 underwent small bowel biopsy. Biopsy was strongly recommended in 12 others, but their families refused; some families elected to initiate a gluten-free diet without a biopsy. In children with only minor elevations in titer levels, physicians did not recommend biopsy, Dr. Schaub said.

The probability of biopsy being performed became more likely with increasing tissue transglutaminase (tTG) antibody titers levels, but age, race/ethnicity, and sex did not significantly affect the likelihood of biopsy, she noted.

Celiac disease was diagnosed in 15 children (2% of the overall study population, which is lower than in some other studies), including 54% of those who underwent small bowel biopsy, and 21% of those with celiac autoimmunity.

Only one child who was seronegative at diagnosis later tested positive for celiac autoimmunity and celiac disease on repeat testing, Dr. Schaub said, noting that celiac disease occurred significantly more often in non-Hispanic white children (2.9%), than in Hispanic children (0.7%) or African American children (0%).

Of note, those with autoimmunity had lower body mass index, compared with those without celiac autoimmunity – a finding that did not change when those with celiac disease were excluded from the analysis, said Dr. Schaub.

On multivariate analysis, only tTG levels and race/ethnicity were independent predictors of celiac disease.

A little more than a third (34.8%) of those with celiac autoimmunity at onset of type 1 diabetes became seronegative at 18 months. Many of those patients had very mildly elevated titers, Dr. Schaub said.

The age at onset of type 1 diabetes among the children included in the study was 9.8 years (range of 6 months to 18 years; 61% were between ages 7 and 11 years), and most (58.6%) were non-Hispanic white children, 20.9% were Hispanic, 15.6% were African American, 3.9% were Asian, and 3.7% were mixed race.

Most of the children (95%) underwent tTG immunoglobulin A testing (or tTG immunoglobulin G testing if IgA was deficient) within 3 months of diabetes onset. Repeat screens were conducted in 35.6% of the children; 270 had follow-up screens at more than 18 months after diabetes diagnosis, and 70 had a repeat screens at 36 months or more after diagnosis.

Celiac disease is known to occur more often in patients with type 1 diabetes, Dr. Schaub said, explaining that reported incidence ranges from 1% to 10%, compared with 0.3% to 1% in the general population.

Untreated celiac disease can result in poor growth, difficult glycemic control – including problematic hyperglycemia – and long-term complications including an increased risk of intestinal lymphoproliferative disorder, she said.

A recent paper in Diabetes Care showed that celiac disease is an independent risk factor for the development of nephropathy and retinopathy in patients with type 1 diabetes, she added.

However, current guidelines are inconsistent. For example, current ADA guidelines call for screening at diagnosis, but they state that the effectiveness and optimal frequency of repeat screening remains unclear in asymptomatic patients; some others recommend screening at diagnosis, and repeat screening every 1-2 years thereafter.

The findings suggest that while some children without celiac autoimmunity at the time of type 1 diabetes diagnosis may require annual rescreening, such rescreening “might not be a good use of resources” in those who are asymptomatic, she said, noting that race, tTG titers, and some other factors such as genetics might play a role in recommendations for biopsy.

Also, the findings of lower BMI in children with celiac autoimmunity “certainly warrant further investigation,” she concluded.

Dr. Schaub reported having no disclosures.

BOSTON – Most children diagnosed with type 1 diabetes who develop celiac disease test positive for celiac autoimmunity at the time of their first screen; thus annual rescreening is necessary only in those with a positive first screen and in those who develop celiac disease symptoms, findings from a retrospective records review suggest.

Of 758 children with new-onset type 1 diabetes between August 2007 and March 2012, 69 had celiac autoimmunity, and 96.1% of those were already positive on their first screen, Dr. Rebecca L. Schaub, a pediatric endocrinologist in San Antonio, Texas, reported at the annual scientific sessions of the American Diabetes Association.

Of the children with celiac autoimmunity, 28 underwent small bowel biopsy. Biopsy was strongly recommended in 12 others, but their families refused; some families elected to initiate a gluten-free diet without a biopsy. In children with only minor elevations in titer levels, physicians did not recommend biopsy, Dr. Schaub said.

The probability of biopsy being performed became more likely with increasing tissue transglutaminase (tTG) antibody titers levels, but age, race/ethnicity, and sex did not significantly affect the likelihood of biopsy, she noted.

Celiac disease was diagnosed in 15 children (2% of the overall study population, which is lower than in some other studies), including 54% of those who underwent small bowel biopsy, and 21% of those with celiac autoimmunity.

Only one child who was seronegative at diagnosis later tested positive for celiac autoimmunity and celiac disease on repeat testing, Dr. Schaub said, noting that celiac disease occurred significantly more often in non-Hispanic white children (2.9%), than in Hispanic children (0.7%) or African American children (0%).

Of note, those with autoimmunity had lower body mass index, compared with those without celiac autoimmunity – a finding that did not change when those with celiac disease were excluded from the analysis, said Dr. Schaub.

On multivariate analysis, only tTG levels and race/ethnicity were independent predictors of celiac disease.

A little more than a third (34.8%) of those with celiac autoimmunity at onset of type 1 diabetes became seronegative at 18 months. Many of those patients had very mildly elevated titers, Dr. Schaub said.

The age at onset of type 1 diabetes among the children included in the study was 9.8 years (range of 6 months to 18 years; 61% were between ages 7 and 11 years), and most (58.6%) were non-Hispanic white children, 20.9% were Hispanic, 15.6% were African American, 3.9% were Asian, and 3.7% were mixed race.

Most of the children (95%) underwent tTG immunoglobulin A testing (or tTG immunoglobulin G testing if IgA was deficient) within 3 months of diabetes onset. Repeat screens were conducted in 35.6% of the children; 270 had follow-up screens at more than 18 months after diabetes diagnosis, and 70 had a repeat screens at 36 months or more after diagnosis.

Celiac disease is known to occur more often in patients with type 1 diabetes, Dr. Schaub said, explaining that reported incidence ranges from 1% to 10%, compared with 0.3% to 1% in the general population.

Untreated celiac disease can result in poor growth, difficult glycemic control – including problematic hyperglycemia – and long-term complications including an increased risk of intestinal lymphoproliferative disorder, she said.

A recent paper in Diabetes Care showed that celiac disease is an independent risk factor for the development of nephropathy and retinopathy in patients with type 1 diabetes, she added.

However, current guidelines are inconsistent. For example, current ADA guidelines call for screening at diagnosis, but they state that the effectiveness and optimal frequency of repeat screening remains unclear in asymptomatic patients; some others recommend screening at diagnosis, and repeat screening every 1-2 years thereafter.

The findings suggest that while some children without celiac autoimmunity at the time of type 1 diabetes diagnosis may require annual rescreening, such rescreening “might not be a good use of resources” in those who are asymptomatic, she said, noting that race, tTG titers, and some other factors such as genetics might play a role in recommendations for biopsy.

Also, the findings of lower BMI in children with celiac autoimmunity “certainly warrant further investigation,” she concluded.

Dr. Schaub reported having no disclosures.

BOSTON – Most children diagnosed with type 1 diabetes who develop celiac disease test positive for celiac autoimmunity at the time of their first screen; thus annual rescreening is necessary only in those with a positive first screen and in those who develop celiac disease symptoms, findings from a retrospective records review suggest.

Of 758 children with new-onset type 1 diabetes between August 2007 and March 2012, 69 had celiac autoimmunity, and 96.1% of those were already positive on their first screen, Dr. Rebecca L. Schaub, a pediatric endocrinologist in San Antonio, Texas, reported at the annual scientific sessions of the American Diabetes Association.

Of the children with celiac autoimmunity, 28 underwent small bowel biopsy. Biopsy was strongly recommended in 12 others, but their families refused; some families elected to initiate a gluten-free diet without a biopsy. In children with only minor elevations in titer levels, physicians did not recommend biopsy, Dr. Schaub said.

The probability of biopsy being performed became more likely with increasing tissue transglutaminase (tTG) antibody titers levels, but age, race/ethnicity, and sex did not significantly affect the likelihood of biopsy, she noted.

Celiac disease was diagnosed in 15 children (2% of the overall study population, which is lower than in some other studies), including 54% of those who underwent small bowel biopsy, and 21% of those with celiac autoimmunity.

Only one child who was seronegative at diagnosis later tested positive for celiac autoimmunity and celiac disease on repeat testing, Dr. Schaub said, noting that celiac disease occurred significantly more often in non-Hispanic white children (2.9%), than in Hispanic children (0.7%) or African American children (0%).

Of note, those with autoimmunity had lower body mass index, compared with those without celiac autoimmunity – a finding that did not change when those with celiac disease were excluded from the analysis, said Dr. Schaub.

On multivariate analysis, only tTG levels and race/ethnicity were independent predictors of celiac disease.

A little more than a third (34.8%) of those with celiac autoimmunity at onset of type 1 diabetes became seronegative at 18 months. Many of those patients had very mildly elevated titers, Dr. Schaub said.

The age at onset of type 1 diabetes among the children included in the study was 9.8 years (range of 6 months to 18 years; 61% were between ages 7 and 11 years), and most (58.6%) were non-Hispanic white children, 20.9% were Hispanic, 15.6% were African American, 3.9% were Asian, and 3.7% were mixed race.

Most of the children (95%) underwent tTG immunoglobulin A testing (or tTG immunoglobulin G testing if IgA was deficient) within 3 months of diabetes onset. Repeat screens were conducted in 35.6% of the children; 270 had follow-up screens at more than 18 months after diabetes diagnosis, and 70 had a repeat screens at 36 months or more after diagnosis.

Celiac disease is known to occur more often in patients with type 1 diabetes, Dr. Schaub said, explaining that reported incidence ranges from 1% to 10%, compared with 0.3% to 1% in the general population.

Untreated celiac disease can result in poor growth, difficult glycemic control – including problematic hyperglycemia – and long-term complications including an increased risk of intestinal lymphoproliferative disorder, she said.

A recent paper in Diabetes Care showed that celiac disease is an independent risk factor for the development of nephropathy and retinopathy in patients with type 1 diabetes, she added.

However, current guidelines are inconsistent. For example, current ADA guidelines call for screening at diagnosis, but they state that the effectiveness and optimal frequency of repeat screening remains unclear in asymptomatic patients; some others recommend screening at diagnosis, and repeat screening every 1-2 years thereafter.

The findings suggest that while some children without celiac autoimmunity at the time of type 1 diabetes diagnosis may require annual rescreening, such rescreening “might not be a good use of resources” in those who are asymptomatic, she said, noting that race, tTG titers, and some other factors such as genetics might play a role in recommendations for biopsy.

Also, the findings of lower BMI in children with celiac autoimmunity “certainly warrant further investigation,” she concluded.

Dr. Schaub reported having no disclosures.

sworcester@frontlinemedcom.com

BOSTON – Most children diagnosed with type 1 diabetes who develop celiac disease test positive for celiac autoimmunity at the time of their first screen; thus annual rescreening is necessary only in those with a positive first screen and in those who develop celiac disease symptoms, findings from a retrospective records review suggest.

Of 758 children with new-onset type 1 diabetes between August 2007 and March 2012, 69 had celiac autoimmunity, and 96.1% of those were already positive on their first screen, Dr. Rebecca L. Schaub, a pediatric endocrinologist in San Antonio, Texas, reported at the annual scientific sessions of the American Diabetes Association.

Of the children with celiac autoimmunity, 28 underwent small bowel biopsy. Biopsy was strongly recommended in 12 others, but their families refused; some families elected to initiate a gluten-free diet without a biopsy. In children with only minor elevations in titer levels, physicians did not recommend biopsy, Dr. Schaub said.

The probability of biopsy being performed became more likely with increasing tissue transglutaminase (tTG) antibody titers levels, but age, race/ethnicity, and sex did not significantly affect the likelihood of biopsy, she noted.

Celiac disease was diagnosed in 15 children (2% of the overall study population, which is lower than in some other studies), including 54% of those who underwent small bowel biopsy, and 21% of those with celiac autoimmunity.

Only one child who was seronegative at diagnosis later tested positive for celiac autoimmunity and celiac disease on repeat testing, Dr. Schaub said, noting that celiac disease occurred significantly more often in non-Hispanic white children (2.9%), than in Hispanic children (0.7%) or African American children (0%).

Of note, those with autoimmunity had lower body mass index, compared with those without celiac autoimmunity – a finding that did not change when those with celiac disease were excluded from the analysis, said Dr. Schaub.

On multivariate analysis, only tTG levels and race/ethnicity were independent predictors of celiac disease.

A little more than a third (34.8%) of those with celiac autoimmunity at onset of type 1 diabetes became seronegative at 18 months. Many of those patients had very mildly elevated titers, Dr. Schaub said.

The age at onset of type 1 diabetes among the children included in the study was 9.8 years (range of 6 months to 18 years; 61% were between ages 7 and 11 years), and most (58.6%) were non-Hispanic white children, 20.9% were Hispanic, 15.6% were African American, 3.9% were Asian, and 3.7% were mixed race.

Most of the children (95%) underwent tTG immunoglobulin A testing (or tTG immunoglobulin G testing if IgA was deficient) within 3 months of diabetes onset. Repeat screens were conducted in 35.6% of the children; 270 had follow-up screens at more than 18 months after diabetes diagnosis, and 70 had a repeat screens at 36 months or more after diagnosis.

Celiac disease is known to occur more often in patients with type 1 diabetes, Dr. Schaub said, explaining that reported incidence ranges from 1% to 10%, compared with 0.3% to 1% in the general population.

Untreated celiac disease can result in poor growth, difficult glycemic control – including problematic hyperglycemia – and long-term complications including an increased risk of intestinal lymphoproliferative disorder, she said.

A recent paper in Diabetes Care showed that celiac disease is an independent risk factor for the development of nephropathy and retinopathy in patients with type 1 diabetes, she added.

However, current guidelines are inconsistent. For example, current ADA guidelines call for screening at diagnosis, but they state that the effectiveness and optimal frequency of repeat screening remains unclear in asymptomatic patients; some others recommend screening at diagnosis, and repeat screening every 1-2 years thereafter.

The findings suggest that while some children without celiac autoimmunity at the time of type 1 diabetes diagnosis may require annual rescreening, such rescreening “might not be a good use of resources” in those who are asymptomatic, she said, noting that race, tTG titers, and some other factors such as genetics might play a role in recommendations for biopsy.

Also, the findings of lower BMI in children with celiac autoimmunity “certainly warrant further investigation,” she concluded.

Dr. Schaub reported having no disclosures.

sworcester@frontlinemedcom.com

BOSTON – Most children diagnosed with type 1 diabetes who develop celiac disease test positive for celiac autoimmunity at the time of their first screen; thus annual rescreening is necessary only in those with a positive first screen and in those who develop celiac disease symptoms, findings from a retrospective records review suggest.

Of 758 children with new-onset type 1 diabetes between August 2007 and March 2012, 69 had celiac autoimmunity, and 96.1% of those were already positive on their first screen, Dr. Rebecca L. Schaub, a pediatric endocrinologist in San Antonio, Texas, reported at the annual scientific sessions of the American Diabetes Association.

Of the children with celiac autoimmunity, 28 underwent small bowel biopsy. Biopsy was strongly recommended in 12 others, but their families refused; some families elected to initiate a gluten-free diet without a biopsy. In children with only minor elevations in titer levels, physicians did not recommend biopsy, Dr. Schaub said.

The probability of biopsy being performed became more likely with increasing tissue transglutaminase (tTG) antibody titers levels, but age, race/ethnicity, and sex did not significantly affect the likelihood of biopsy, she noted.

Celiac disease was diagnosed in 15 children (2% of the overall study population, which is lower than in some other studies), including 54% of those who underwent small bowel biopsy, and 21% of those with celiac autoimmunity.

Only one child who was seronegative at diagnosis later tested positive for celiac autoimmunity and celiac disease on repeat testing, Dr. Schaub said, noting that celiac disease occurred significantly more often in non-Hispanic white children (2.9%), than in Hispanic children (0.7%) or African American children (0%).

Of note, those with autoimmunity had lower body mass index, compared with those without celiac autoimmunity – a finding that did not change when those with celiac disease were excluded from the analysis, said Dr. Schaub.

On multivariate analysis, only tTG levels and race/ethnicity were independent predictors of celiac disease.

A little more than a third (34.8%) of those with celiac autoimmunity at onset of type 1 diabetes became seronegative at 18 months. Many of those patients had very mildly elevated titers, Dr. Schaub said.

The age at onset of type 1 diabetes among the children included in the study was 9.8 years (range of 6 months to 18 years; 61% were between ages 7 and 11 years), and most (58.6%) were non-Hispanic white children, 20.9% were Hispanic, 15.6% were African American, 3.9% were Asian, and 3.7% were mixed race.

Most of the children (95%) underwent tTG immunoglobulin A testing (or tTG immunoglobulin G testing if IgA was deficient) within 3 months of diabetes onset. Repeat screens were conducted in 35.6% of the children; 270 had follow-up screens at more than 18 months after diabetes diagnosis, and 70 had a repeat screens at 36 months or more after diagnosis.

Celiac disease is known to occur more often in patients with type 1 diabetes, Dr. Schaub said, explaining that reported incidence ranges from 1% to 10%, compared with 0.3% to 1% in the general population.

Untreated celiac disease can result in poor growth, difficult glycemic control – including problematic hyperglycemia – and long-term complications including an increased risk of intestinal lymphoproliferative disorder, she said.

A recent paper in Diabetes Care showed that celiac disease is an independent risk factor for the development of nephropathy and retinopathy in patients with type 1 diabetes, she added.

However, current guidelines are inconsistent. For example, current ADA guidelines call for screening at diagnosis, but they state that the effectiveness and optimal frequency of repeat screening remains unclear in asymptomatic patients; some others recommend screening at diagnosis, and repeat screening every 1-2 years thereafter.

The findings suggest that while some children without celiac autoimmunity at the time of type 1 diabetes diagnosis may require annual rescreening, such rescreening “might not be a good use of resources” in those who are asymptomatic, she said, noting that race, tTG titers, and some other factors such as genetics might play a role in recommendations for biopsy.

Also, the findings of lower BMI in children with celiac autoimmunity “certainly warrant further investigation,” she concluded.

Dr. Schaub reported having no disclosures.

sworcester@frontlinemedcom.com

DENVER – Inhaled corticosteroid plus long-acting beta₂-agonist therapy is overused in patients with mild COPD, based on a post hoc analysis of two pivotal phase III studies.

At entry in the phase III TONADO studies, nearly 40% of patients who were classified as having GOLD A or B disease were receiving ICS maintenance therapy either alone, in free combination, or as fixed-dose combination therapy, Dr. Henrik Watz of the Pulmonary Research Institute at Lung Clinic Grosshansdorf, Airway Research Center North, Grosshansdorf, Germany, and his colleagues reported at an international conference of the American Thoracic Society.

Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines recommend that use of inhaled corticosteroids (ICS) and long-acting beta₂-agonist (LABA) therapy be restricted to patients with severe or very severe COPD (category C or D disease) with frequent exacerbations.

The post-hoc analysis “confirms previous reports highlighting that treatment regimens containing ICS therapy are being used early in the management of patients with COPD, which may not be appropriate based on current GOLD recommendations. Furthermore, consistent improvements in lung function with tiotropium plus olodaterol versus the monocomponents were demonstrated in GOLD A, B, C, and D, regardless of previous ICS use,” Dr. Watz and his associates concluded.

The replicate TONADO studies (TONADO 1 and 2) were multicenter, randomized, double-blind, active-controlled studies evaluating the once-daily long-acting muscarinic agent (LAMA) tiotropium and the LABA olodaterol. The 5,162 patients were randomized to once-daily treatment with inhaled tiotropium plus olodaterol (Respimat FDC), to tiotropium, or to olodaterol for 52 weeks.

Of the study participants, 2,132 had GOLD A/B disease, and 3,030 had GOLD C/D disease, based on exacerbation history and lung function. All had postbronchodilator forced expiratory volume in 1 second (FEV₁) that was less than 80% of predicted normal, and FEV₁/forced vital capacity of less than 70%. All were current or exsmokers with a history of more than 10 pack-years.

At study entry, 7.2% of the GOLD A/B patients were treated with ICS without a LABA, and 31.1% were receiving ICS and a LABA. Of the GOLD C/D patients, 8.8% were receiving ICS without a LABA and 45% were receiving ICS with a LABA.

During the study, those who received both tiotropium and olodaterol had significant improvements in lung function, compared with those receiving only tiotropium. Among patients who had previously used ICS and received both drugs, the FEV₁ area under the curve at 0-3 hours was 0.310 L for GOLD A/B patients and 0.236 L for GOLD C/D patients. For those with no prior ICS use, the FEV₁ area under the curve at 0-3 hours was 0.277 L for GOLD A/B patients and 0.251 L for GOLD C/D patients.

For those with prior ICS use, trough FEV₁ was 0.160 L for GOLD A/B patients and 0.122 L for GOLD C/D patients receiving both tiotropium and olodaterol. For those with no prior ICS use, trough FEV₁ was 0.142 L for GOLD A/B patients and 0.149 L for GOLD C/D patients.

The TONADO studies included patients with moderate to very severe disease, but were conducted when the GOLD guidelines recommended that ICS plus LABA therapy be restricted to those with severe or very severe COPD and repeated exacerbations – before the guidelines were updated to take into account COPD symptoms. The updated guidelines call for ICS plus LABA maintenance therapy for patients in categories C and D disease with frequent exacerbations.

This study was supported by Boehringer Ingelheim, the maker of Respimat FDC.

sworcester@frontlinemedcom.com

DENVER – Inhaled corticosteroid plus long-acting beta₂-agonist therapy is overused in patients with mild COPD, based on a post hoc analysis of two pivotal phase III studies.

At entry in the phase III TONADO studies, nearly 40% of patients who were classified as having GOLD A or B disease were receiving ICS maintenance therapy either alone, in free combination, or as fixed-dose combination therapy, Dr. Henrik Watz of the Pulmonary Research Institute at Lung Clinic Grosshansdorf, Airway Research Center North, Grosshansdorf, Germany, and his colleagues reported at an international conference of the American Thoracic Society.

Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines recommend that use of inhaled corticosteroids (ICS) and long-acting beta₂-agonist (LABA) therapy be restricted to patients with severe or very severe COPD (category C or D disease) with frequent exacerbations.

The post-hoc analysis “confirms previous reports highlighting that treatment regimens containing ICS therapy are being used early in the management of patients with COPD, which may not be appropriate based on current GOLD recommendations. Furthermore, consistent improvements in lung function with tiotropium plus olodaterol versus the monocomponents were demonstrated in GOLD A, B, C, and D, regardless of previous ICS use,” Dr. Watz and his associates concluded.

The replicate TONADO studies (TONADO 1 and 2) were multicenter, randomized, double-blind, active-controlled studies evaluating the once-daily long-acting muscarinic agent (LAMA) tiotropium and the LABA olodaterol. The 5,162 patients were randomized to once-daily treatment with inhaled tiotropium plus olodaterol (Respimat FDC), to tiotropium, or to olodaterol for 52 weeks.

Of the study participants, 2,132 had GOLD A/B disease, and 3,030 had GOLD C/D disease, based on exacerbation history and lung function. All had postbronchodilator forced expiratory volume in 1 second (FEV₁) that was less than 80% of predicted normal, and FEV₁/forced vital capacity of less than 70%. All were current or exsmokers with a history of more than 10 pack-years.

At study entry, 7.2% of the GOLD A/B patients were treated with ICS without a LABA, and 31.1% were receiving ICS and a LABA. Of the GOLD C/D patients, 8.8% were receiving ICS without a LABA and 45% were receiving ICS with a LABA.

During the study, those who received both tiotropium and olodaterol had significant improvements in lung function, compared with those receiving only tiotropium. Among patients who had previously used ICS and received both drugs, the FEV₁ area under the curve at 0-3 hours was 0.310 L for GOLD A/B patients and 0.236 L for GOLD C/D patients. For those with no prior ICS use, the FEV₁ area under the curve at 0-3 hours was 0.277 L for GOLD A/B patients and 0.251 L for GOLD C/D patients.

For those with prior ICS use, trough FEV₁ was 0.160 L for GOLD A/B patients and 0.122 L for GOLD C/D patients receiving both tiotropium and olodaterol. For those with no prior ICS use, trough FEV₁ was 0.142 L for GOLD A/B patients and 0.149 L for GOLD C/D patients.

The TONADO studies included patients with moderate to very severe disease, but were conducted when the GOLD guidelines recommended that ICS plus LABA therapy be restricted to those with severe or very severe COPD and repeated exacerbations – before the guidelines were updated to take into account COPD symptoms. The updated guidelines call for ICS plus LABA maintenance therapy for patients in categories C and D disease with frequent exacerbations.

This study was supported by Boehringer Ingelheim, the maker of Respimat FDC.

sworcester@frontlinemedcom.com

DENVER – Inhaled corticosteroid plus long-acting beta₂-agonist therapy is overused in patients with mild COPD, based on a post hoc analysis of two pivotal phase III studies.

At entry in the phase III TONADO studies, nearly 40% of patients who were classified as having GOLD A or B disease were receiving ICS maintenance therapy either alone, in free combination, or as fixed-dose combination therapy, Dr. Henrik Watz of the Pulmonary Research Institute at Lung Clinic Grosshansdorf, Airway Research Center North, Grosshansdorf, Germany, and his colleagues reported at an international conference of the American Thoracic Society.

Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines recommend that use of inhaled corticosteroids (ICS) and long-acting beta₂-agonist (LABA) therapy be restricted to patients with severe or very severe COPD (category C or D disease) with frequent exacerbations.

The post-hoc analysis “confirms previous reports highlighting that treatment regimens containing ICS therapy are being used early in the management of patients with COPD, which may not be appropriate based on current GOLD recommendations. Furthermore, consistent improvements in lung function with tiotropium plus olodaterol versus the monocomponents were demonstrated in GOLD A, B, C, and D, regardless of previous ICS use,” Dr. Watz and his associates concluded.

The replicate TONADO studies (TONADO 1 and 2) were multicenter, randomized, double-blind, active-controlled studies evaluating the once-daily long-acting muscarinic agent (LAMA) tiotropium and the LABA olodaterol. The 5,162 patients were randomized to once-daily treatment with inhaled tiotropium plus olodaterol (Respimat FDC), to tiotropium, or to olodaterol for 52 weeks.

Of the study participants, 2,132 had GOLD A/B disease, and 3,030 had GOLD C/D disease, based on exacerbation history and lung function. All had postbronchodilator forced expiratory volume in 1 second (FEV₁) that was less than 80% of predicted normal, and FEV₁/forced vital capacity of less than 70%. All were current or exsmokers with a history of more than 10 pack-years.

At study entry, 7.2% of the GOLD A/B patients were treated with ICS without a LABA, and 31.1% were receiving ICS and a LABA. Of the GOLD C/D patients, 8.8% were receiving ICS without a LABA and 45% were receiving ICS with a LABA.

During the study, those who received both tiotropium and olodaterol had significant improvements in lung function, compared with those receiving only tiotropium. Among patients who had previously used ICS and received both drugs, the FEV₁ area under the curve at 0-3 hours was 0.310 L for GOLD A/B patients and 0.236 L for GOLD C/D patients. For those with no prior ICS use, the FEV₁ area under the curve at 0-3 hours was 0.277 L for GOLD A/B patients and 0.251 L for GOLD C/D patients.

For those with prior ICS use, trough FEV₁ was 0.160 L for GOLD A/B patients and 0.122 L for GOLD C/D patients receiving both tiotropium and olodaterol. For those with no prior ICS use, trough FEV₁ was 0.142 L for GOLD A/B patients and 0.149 L for GOLD C/D patients.

The TONADO studies included patients with moderate to very severe disease, but were conducted when the GOLD guidelines recommended that ICS plus LABA therapy be restricted to those with severe or very severe COPD and repeated exacerbations – before the guidelines were updated to take into account COPD symptoms. The updated guidelines call for ICS plus LABA maintenance therapy for patients in categories C and D disease with frequent exacerbations.

This study was supported by Boehringer Ingelheim, the maker of Respimat FDC.

sworcester@frontlinemedcom.com

ROME – Radiographic progression occurs at similar rates in the spines of ankylosing spondylitis patients treated over 2 years with either continuous or on-demand diclofenac, according to results from a randomized, prospective multicenter trial presented at the European Congress of Rheumatology.

In the ENRADAS (Effects of NSAIDs on Radiographic Damage in Ankylosing Spondylitis) trial, Dr. Joachim Sieper of Charite-Universitätsmedizin Berlin and his colleagues compared continuous treatment with at least 50% of the maximum 150-mg daily dose of the NSAID diclofenac and on-demand treatment with diclofenac. During the entire 2 years of the study, no patient received treatment with a tumor necrosis factor blocker or any other drug other than diclofenac.

Mitchel L. Zoler/Frontline Medical News

The investigators measured radiographic spine progression using the modified Stoke Ankylosing Spondylitis Spinal Score(mSASSS). At baseline, patients randomized to continuous treatment who had complete radiographic follow-up had a mean mSASSS of 10.9, while those randomized to the on-demand arm had a mean mSASSS of 16.4. After 2 years on treatment, the average change in mSASSS from baseline was 1.28 for the 62 patients in the continuous-treatment group and 0.79 for the 60 patients in the on-demand group, a difference that was not statistically significant, Dr. Sieper said.

There also was no statistically significant between-group difference when the analysis focused on the subgroup of patients who were C-reactive protein positive at baseline, 55% and 58% of patients in the groups, respectively, who had their average mSASSS increase by 1.68, compared with 0.96. Similarly, when the analysis focused only on patients who had syndesmophytes at baseline, 53% and 62% of patients, respectively, the average increases in mSASSS were 2.11 and 0.95, a difference that was not statistically significant. Presence of C-reactive protein and syndesmophytes are both known risk factors for radiographic progression.

Patient characteristics were similar in the two groups. NSAID intake over the 2-year study period, measured using a 0-100 composite score based on treatment duration and NSAID doses and intervals, was a mean of 76 vs. 44 for the continuous and on-demand groups, respectively. At the study’s end, 77% of patients remained on diclofenac and had not switched to another NSAID.

Side effects were similar in both groups, with 19 serious adverse events in the continuous-treatment patients and 21 serious adverse events in the on-demand patients.

Previous studies have suggested that NSAIDs given continuously over 2 years reduce radiographic progression, compared with on-demand therapy, in ankylosing spondylitis patients. Similar effects were seen in a prospective cohort.

“In our study, continuous vs. on-demand treatment … did not prevent radiographic progression in [ankylosing spondylitis]. It is highly unlikely that the results would have been different with a higher number of patients, because we found a trend for less progression in the on-demand group,” Dr. Sieper said.

Additional study is needed to determine whether an NSAID other than diclofenac, specifically a COX-2 selective drug, would have a different effect on radiographic progression, he said.

Dr. Sieper reported receiving honorarium for consultancies, speaker’s bureaus, or grants from AbbVie, Janssen, Merck, Lily, Novartis, Pfizer, and UCB.

sworcester@frontlinemedcom.com

ROME – Radiographic progression occurs at similar rates in the spines of ankylosing spondylitis patients treated over 2 years with either continuous or on-demand diclofenac, according to results from a randomized, prospective multicenter trial presented at the European Congress of Rheumatology.

In the ENRADAS (Effects of NSAIDs on Radiographic Damage in Ankylosing Spondylitis) trial, Dr. Joachim Sieper of Charite-Universitätsmedizin Berlin and his colleagues compared continuous treatment with at least 50% of the maximum 150-mg daily dose of the NSAID diclofenac and on-demand treatment with diclofenac. During the entire 2 years of the study, no patient received treatment with a tumor necrosis factor blocker or any other drug other than diclofenac.

Mitchel L. Zoler/Frontline Medical News

The investigators measured radiographic spine progression using the modified Stoke Ankylosing Spondylitis Spinal Score(mSASSS). At baseline, patients randomized to continuous treatment who had complete radiographic follow-up had a mean mSASSS of 10.9, while those randomized to the on-demand arm had a mean mSASSS of 16.4. After 2 years on treatment, the average change in mSASSS from baseline was 1.28 for the 62 patients in the continuous-treatment group and 0.79 for the 60 patients in the on-demand group, a difference that was not statistically significant, Dr. Sieper said.

There also was no statistically significant between-group difference when the analysis focused on the subgroup of patients who were C-reactive protein positive at baseline, 55% and 58% of patients in the groups, respectively, who had their average mSASSS increase by 1.68, compared with 0.96. Similarly, when the analysis focused only on patients who had syndesmophytes at baseline, 53% and 62% of patients, respectively, the average increases in mSASSS were 2.11 and 0.95, a difference that was not statistically significant. Presence of C-reactive protein and syndesmophytes are both known risk factors for radiographic progression.

Patient characteristics were similar in the two groups. NSAID intake over the 2-year study period, measured using a 0-100 composite score based on treatment duration and NSAID doses and intervals, was a mean of 76 vs. 44 for the continuous and on-demand groups, respectively. At the study’s end, 77% of patients remained on diclofenac and had not switched to another NSAID.

Side effects were similar in both groups, with 19 serious adverse events in the continuous-treatment patients and 21 serious adverse events in the on-demand patients.

Previous studies have suggested that NSAIDs given continuously over 2 years reduce radiographic progression, compared with on-demand therapy, in ankylosing spondylitis patients. Similar effects were seen in a prospective cohort.

“In our study, continuous vs. on-demand treatment … did not prevent radiographic progression in [ankylosing spondylitis]. It is highly unlikely that the results would have been different with a higher number of patients, because we found a trend for less progression in the on-demand group,” Dr. Sieper said.

Additional study is needed to determine whether an NSAID other than diclofenac, specifically a COX-2 selective drug, would have a different effect on radiographic progression, he said.

Dr. Sieper reported receiving honorarium for consultancies, speaker’s bureaus, or grants from AbbVie, Janssen, Merck, Lily, Novartis, Pfizer, and UCB.

sworcester@frontlinemedcom.com

ROME – Radiographic progression occurs at similar rates in the spines of ankylosing spondylitis patients treated over 2 years with either continuous or on-demand diclofenac, according to results from a randomized, prospective multicenter trial presented at the European Congress of Rheumatology.

In the ENRADAS (Effects of NSAIDs on Radiographic Damage in Ankylosing Spondylitis) trial, Dr. Joachim Sieper of Charite-Universitätsmedizin Berlin and his colleagues compared continuous treatment with at least 50% of the maximum 150-mg daily dose of the NSAID diclofenac and on-demand treatment with diclofenac. During the entire 2 years of the study, no patient received treatment with a tumor necrosis factor blocker or any other drug other than diclofenac.

Mitchel L. Zoler/Frontline Medical News

The investigators measured radiographic spine progression using the modified Stoke Ankylosing Spondylitis Spinal Score(mSASSS). At baseline, patients randomized to continuous treatment who had complete radiographic follow-up had a mean mSASSS of 10.9, while those randomized to the on-demand arm had a mean mSASSS of 16.4. After 2 years on treatment, the average change in mSASSS from baseline was 1.28 for the 62 patients in the continuous-treatment group and 0.79 for the 60 patients in the on-demand group, a difference that was not statistically significant, Dr. Sieper said.

There also was no statistically significant between-group difference when the analysis focused on the subgroup of patients who were C-reactive protein positive at baseline, 55% and 58% of patients in the groups, respectively, who had their average mSASSS increase by 1.68, compared with 0.96. Similarly, when the analysis focused only on patients who had syndesmophytes at baseline, 53% and 62% of patients, respectively, the average increases in mSASSS were 2.11 and 0.95, a difference that was not statistically significant. Presence of C-reactive protein and syndesmophytes are both known risk factors for radiographic progression.

Patient characteristics were similar in the two groups. NSAID intake over the 2-year study period, measured using a 0-100 composite score based on treatment duration and NSAID doses and intervals, was a mean of 76 vs. 44 for the continuous and on-demand groups, respectively. At the study’s end, 77% of patients remained on diclofenac and had not switched to another NSAID.

Side effects were similar in both groups, with 19 serious adverse events in the continuous-treatment patients and 21 serious adverse events in the on-demand patients.

Previous studies have suggested that NSAIDs given continuously over 2 years reduce radiographic progression, compared with on-demand therapy, in ankylosing spondylitis patients. Similar effects were seen in a prospective cohort.

“In our study, continuous vs. on-demand treatment … did not prevent radiographic progression in [ankylosing spondylitis]. It is highly unlikely that the results would have been different with a higher number of patients, because we found a trend for less progression in the on-demand group,” Dr. Sieper said.

Additional study is needed to determine whether an NSAID other than diclofenac, specifically a COX-2 selective drug, would have a different effect on radiographic progression, he said.

Dr. Sieper reported receiving honorarium for consultancies, speaker’s bureaus, or grants from AbbVie, Janssen, Merck, Lily, Novartis, Pfizer, and UCB.

sworcester@frontlinemedcom.com

DENVER – The rate of asthma exacerbations was reduced more among elderly patients than among younger patients treated with mepolizumab vs. placebo as part of the Mepolizumab as Adjunctive Therapy in Patients with Severe Asthma (MENSA) trial, according to a post hoc analysis of the trial data.

The analysis also demonstrated that mepolizumab improved quality of life, compared with standard care, in both older and younger patients, although little differentiation was seen with respect to asthma control, Dr. Hector Ortega reported in a poster at an international conference of the American Thoracic Society.

A 76% greater reduction in clinically significant exacerbations was seen in 54 mepolizumab-treated patients aged 65 years and older in the trial, compared with 26 in that age group who received placebo (mean exacerbation rate per year, 0.92 vs. 1.65); a 44% greater reduction was seen in 331 mepolizumab-treated patients under age 65 years, compared with 165 in that age group who received placebo (mean exacerbation rate per year, 0.42 vs. 1.78), said Dr. Ortega, medical director at GlaxoSmithKline, Research Triangle Park, N.C.

The adjusted mean difference vs. placebo in change in St. George’s Respiratory Questionnaire scores from baseline to 32 weeks was -4.5 in the older patients, and -7.3 in the younger patients, and the adjusted mean difference vs. placebo in change in Asthma Control Questionnaire scores from baseline to 32 weeks was -0.1 and -0.5 in the older and younger patients, respectively, he noted.

The older patients, as expected, suffered more frequently from comorbidities, and this may have been accentuated by the chronic use of inhaled and oral corticosteroids in the older patients.

However, comorbidities had no impact on the response to treatment, and the safety profile of mepolizumab was similar to placebo in both age groups, he said.

Patients in the multicenter, randomized, placebo-controlled MENSA trial received high dose inhaled corticosteroids plus at least one additional controller, had a history of frequent exacerbations and a predefined eosinophilic threshold, and were randomized to receive add-on therapy with either 75 mg of intravenous mepolizumab, 100 mg subcutaneous mepolizumab, or corresponding placebo every 4 weeks for 32 weeks. In the primary planned analysis, the responses to the two doses of mepolizumab were similar, but efficacy in older patients had not been previously reported.

The MENSA trial and post hoc analysis were funded by GSK. Dr. Ortega is employed by GSK.

sworcester@frontlinemedcom.com

DENVER – The rate of asthma exacerbations was reduced more among elderly patients than among younger patients treated with mepolizumab vs. placebo as part of the Mepolizumab as Adjunctive Therapy in Patients with Severe Asthma (MENSA) trial, according to a post hoc analysis of the trial data.

The analysis also demonstrated that mepolizumab improved quality of life, compared with standard care, in both older and younger patients, although little differentiation was seen with respect to asthma control, Dr. Hector Ortega reported in a poster at an international conference of the American Thoracic Society.

A 76% greater reduction in clinically significant exacerbations was seen in 54 mepolizumab-treated patients aged 65 years and older in the trial, compared with 26 in that age group who received placebo (mean exacerbation rate per year, 0.92 vs. 1.65); a 44% greater reduction was seen in 331 mepolizumab-treated patients under age 65 years, compared with 165 in that age group who received placebo (mean exacerbation rate per year, 0.42 vs. 1.78), said Dr. Ortega, medical director at GlaxoSmithKline, Research Triangle Park, N.C.

The adjusted mean difference vs. placebo in change in St. George’s Respiratory Questionnaire scores from baseline to 32 weeks was -4.5 in the older patients, and -7.3 in the younger patients, and the adjusted mean difference vs. placebo in change in Asthma Control Questionnaire scores from baseline to 32 weeks was -0.1 and -0.5 in the older and younger patients, respectively, he noted.

The older patients, as expected, suffered more frequently from comorbidities, and this may have been accentuated by the chronic use of inhaled and oral corticosteroids in the older patients.

However, comorbidities had no impact on the response to treatment, and the safety profile of mepolizumab was similar to placebo in both age groups, he said.

Patients in the multicenter, randomized, placebo-controlled MENSA trial received high dose inhaled corticosteroids plus at least one additional controller, had a history of frequent exacerbations and a predefined eosinophilic threshold, and were randomized to receive add-on therapy with either 75 mg of intravenous mepolizumab, 100 mg subcutaneous mepolizumab, or corresponding placebo every 4 weeks for 32 weeks. In the primary planned analysis, the responses to the two doses of mepolizumab were similar, but efficacy in older patients had not been previously reported.

The MENSA trial and post hoc analysis were funded by GSK. Dr. Ortega is employed by GSK.

sworcester@frontlinemedcom.com

DENVER – The rate of asthma exacerbations was reduced more among elderly patients than among younger patients treated with mepolizumab vs. placebo as part of the Mepolizumab as Adjunctive Therapy in Patients with Severe Asthma (MENSA) trial, according to a post hoc analysis of the trial data.

The analysis also demonstrated that mepolizumab improved quality of life, compared with standard care, in both older and younger patients, although little differentiation was seen with respect to asthma control, Dr. Hector Ortega reported in a poster at an international conference of the American Thoracic Society.

A 76% greater reduction in clinically significant exacerbations was seen in 54 mepolizumab-treated patients aged 65 years and older in the trial, compared with 26 in that age group who received placebo (mean exacerbation rate per year, 0.92 vs. 1.65); a 44% greater reduction was seen in 331 mepolizumab-treated patients under age 65 years, compared with 165 in that age group who received placebo (mean exacerbation rate per year, 0.42 vs. 1.78), said Dr. Ortega, medical director at GlaxoSmithKline, Research Triangle Park, N.C.

The adjusted mean difference vs. placebo in change in St. George’s Respiratory Questionnaire scores from baseline to 32 weeks was -4.5 in the older patients, and -7.3 in the younger patients, and the adjusted mean difference vs. placebo in change in Asthma Control Questionnaire scores from baseline to 32 weeks was -0.1 and -0.5 in the older and younger patients, respectively, he noted.

The older patients, as expected, suffered more frequently from comorbidities, and this may have been accentuated by the chronic use of inhaled and oral corticosteroids in the older patients.

However, comorbidities had no impact on the response to treatment, and the safety profile of mepolizumab was similar to placebo in both age groups, he said.

Patients in the multicenter, randomized, placebo-controlled MENSA trial received high dose inhaled corticosteroids plus at least one additional controller, had a history of frequent exacerbations and a predefined eosinophilic threshold, and were randomized to receive add-on therapy with either 75 mg of intravenous mepolizumab, 100 mg subcutaneous mepolizumab, or corresponding placebo every 4 weeks for 32 weeks. In the primary planned analysis, the responses to the two doses of mepolizumab were similar, but efficacy in older patients had not been previously reported.

The MENSA trial and post hoc analysis were funded by GSK. Dr. Ortega is employed by GSK.

sworcester@frontlinemedcom.com