Miriam E. Tucker

BOSTON – The biomarker glial fibrillary acidic protein accurately distinguished between mild and moderate traumatic brain injury, between mild traumatic injury and controls, and between patients with and without intracranial lesions on CT in a prospective cohort study of emergency department patients with head injuries.

Glial fibrillary acidic protein (GFAP) is found in glial cells and is specific to the central nervous system. Found in both gray and white brain matter, it has recently been identified in serum, which makes it an attractive candidate as a clinical biomarker. Currently, the Glasgow Coma Scale (GCS) is the primary measure used to assess patients with head injury, but it can be influenced by intoxicants, medication, other injuries, or hypoperfusion and was not actually intended as an emergency department tool. "Really what we’d like is to develop some kind of biomarker that can be [measured] quickly and accurately, just like we do troponin for ischemia, or creatinine or bilirubin. Some type of blood test for the brain is our ultimate goal," said Dr. Linda Papa, director of academic clinical research, graduate medical education, Orlando Health, and an attending emergency physician at Orlando (Fla.) Regional Medical Center.

The study enrolled adult patients at three level 1 trauma centers who presented with mild or moderate blunt traumatic brain injury (TBI) and loss of consciousness or change in sensorium. Patients were enrolled from the ED and had blood samples collected within 4 hours of injury. All received CT scans. Control groups included patients with orthopedic trauma or motor vehicle trauma without head injury, and normal healthy people recruited from an ad. One aim of the study was to collect a large amount of normative data, she noted at the annual meeting of the Society for Academic Emergency Medicine.

A total of 307 patients were enrolled in the study, of whom 108 had a TBI. The TBI patients had a mean age of 39 years (range 18-89), and 65% were men. A total of 97 had GCS scores of 13-15 (mild), and 11 had GCS scores of 9-12 (moderate). Of the 97 with GCS 13-15, 24 (25%) had CT scans positive for intracranial lesions, and of the 11 patients with GCS scores 9-12, 8 (73%) had positive CTs. Controls included 176 normal individuals, 16 with non–head injury motor vehicle accidents, and 7 with orthopedic injuries.

Blood samples were drawn within a mean of 2.7 hours after injury. The GFAP biomarker first appeared in the serum within an hour (among those who had blood drawn that soon), increased until 3-4 hours, then leveled off. "It’s very interesting that so early in the course of injury, you can see a marker appearing in the blood," Dr. Papa commented.

Early GFAP levels were able to distinguish TBI patients from uninjured controls with an area under the curve (AUC) of 0.90 (1.0 is perfect), and differentiated those with mild TBI (GCS 15) from all controls with an AUC of 0.88. Mean GFAP levels in patients with negative CT scans versus those with positive CT scans were 0.335 ng/mL and 2.168 ng/mL, a highly significant difference with an AUC of 0.79.

The findings, if validated, suggest that early elevations of GFAP can be a potentially useful clinical tool in determining whether to image patients who are intoxicated or sedated, to admit or discharge patients from the ED, to assess severity of brain injury in a multiple trauma victim, to seek neurosurgical consultation and/or transfer to a neurosurgical facility, and to assess whether the patient can return to play or duty, she said.

Dr. Papa disclosed that she is a scientific consultant for Banyan Biomarkers, the company that is developing GFAP. However, she does not own stock or hold patents with the company. This study was funded by a grant from the Department of Defense and the National Institute of Neurological Disorders and Stroke.

BOSTON – The biomarker glial fibrillary acidic protein accurately distinguished between mild and moderate traumatic brain injury, between mild traumatic injury and controls, and between patients with and without intracranial lesions on CT in a prospective cohort study of emergency department patients with head injuries.

Glial fibrillary acidic protein (GFAP) is found in glial cells and is specific to the central nervous system. Found in both gray and white brain matter, it has recently been identified in serum, which makes it an attractive candidate as a clinical biomarker. Currently, the Glasgow Coma Scale (GCS) is the primary measure used to assess patients with head injury, but it can be influenced by intoxicants, medication, other injuries, or hypoperfusion and was not actually intended as an emergency department tool. "Really what we’d like is to develop some kind of biomarker that can be [measured] quickly and accurately, just like we do troponin for ischemia, or creatinine or bilirubin. Some type of blood test for the brain is our ultimate goal," said Dr. Linda Papa, director of academic clinical research, graduate medical education, Orlando Health, and an attending emergency physician at Orlando (Fla.) Regional Medical Center.

The study enrolled adult patients at three level 1 trauma centers who presented with mild or moderate blunt traumatic brain injury (TBI) and loss of consciousness or change in sensorium. Patients were enrolled from the ED and had blood samples collected within 4 hours of injury. All received CT scans. Control groups included patients with orthopedic trauma or motor vehicle trauma without head injury, and normal healthy people recruited from an ad. One aim of the study was to collect a large amount of normative data, she noted at the annual meeting of the Society for Academic Emergency Medicine.

A total of 307 patients were enrolled in the study, of whom 108 had a TBI. The TBI patients had a mean age of 39 years (range 18-89), and 65% were men. A total of 97 had GCS scores of 13-15 (mild), and 11 had GCS scores of 9-12 (moderate). Of the 97 with GCS 13-15, 24 (25%) had CT scans positive for intracranial lesions, and of the 11 patients with GCS scores 9-12, 8 (73%) had positive CTs. Controls included 176 normal individuals, 16 with non–head injury motor vehicle accidents, and 7 with orthopedic injuries.

Blood samples were drawn within a mean of 2.7 hours after injury. The GFAP biomarker first appeared in the serum within an hour (among those who had blood drawn that soon), increased until 3-4 hours, then leveled off. "It’s very interesting that so early in the course of injury, you can see a marker appearing in the blood," Dr. Papa commented.

Early GFAP levels were able to distinguish TBI patients from uninjured controls with an area under the curve (AUC) of 0.90 (1.0 is perfect), and differentiated those with mild TBI (GCS 15) from all controls with an AUC of 0.88. Mean GFAP levels in patients with negative CT scans versus those with positive CT scans were 0.335 ng/mL and 2.168 ng/mL, a highly significant difference with an AUC of 0.79.

The findings, if validated, suggest that early elevations of GFAP can be a potentially useful clinical tool in determining whether to image patients who are intoxicated or sedated, to admit or discharge patients from the ED, to assess severity of brain injury in a multiple trauma victim, to seek neurosurgical consultation and/or transfer to a neurosurgical facility, and to assess whether the patient can return to play or duty, she said.

Dr. Papa disclosed that she is a scientific consultant for Banyan Biomarkers, the company that is developing GFAP. However, she does not own stock or hold patents with the company. This study was funded by a grant from the Department of Defense and the National Institute of Neurological Disorders and Stroke.

BOSTON – The biomarker glial fibrillary acidic protein accurately distinguished between mild and moderate traumatic brain injury, between mild traumatic injury and controls, and between patients with and without intracranial lesions on CT in a prospective cohort study of emergency department patients with head injuries.

Glial fibrillary acidic protein (GFAP) is found in glial cells and is specific to the central nervous system. Found in both gray and white brain matter, it has recently been identified in serum, which makes it an attractive candidate as a clinical biomarker. Currently, the Glasgow Coma Scale (GCS) is the primary measure used to assess patients with head injury, but it can be influenced by intoxicants, medication, other injuries, or hypoperfusion and was not actually intended as an emergency department tool. "Really what we’d like is to develop some kind of biomarker that can be [measured] quickly and accurately, just like we do troponin for ischemia, or creatinine or bilirubin. Some type of blood test for the brain is our ultimate goal," said Dr. Linda Papa, director of academic clinical research, graduate medical education, Orlando Health, and an attending emergency physician at Orlando (Fla.) Regional Medical Center.

The study enrolled adult patients at three level 1 trauma centers who presented with mild or moderate blunt traumatic brain injury (TBI) and loss of consciousness or change in sensorium. Patients were enrolled from the ED and had blood samples collected within 4 hours of injury. All received CT scans. Control groups included patients with orthopedic trauma or motor vehicle trauma without head injury, and normal healthy people recruited from an ad. One aim of the study was to collect a large amount of normative data, she noted at the annual meeting of the Society for Academic Emergency Medicine.

A total of 307 patients were enrolled in the study, of whom 108 had a TBI. The TBI patients had a mean age of 39 years (range 18-89), and 65% were men. A total of 97 had GCS scores of 13-15 (mild), and 11 had GCS scores of 9-12 (moderate). Of the 97 with GCS 13-15, 24 (25%) had CT scans positive for intracranial lesions, and of the 11 patients with GCS scores 9-12, 8 (73%) had positive CTs. Controls included 176 normal individuals, 16 with non–head injury motor vehicle accidents, and 7 with orthopedic injuries.

Blood samples were drawn within a mean of 2.7 hours after injury. The GFAP biomarker first appeared in the serum within an hour (among those who had blood drawn that soon), increased until 3-4 hours, then leveled off. "It’s very interesting that so early in the course of injury, you can see a marker appearing in the blood," Dr. Papa commented.

Early GFAP levels were able to distinguish TBI patients from uninjured controls with an area under the curve (AUC) of 0.90 (1.0 is perfect), and differentiated those with mild TBI (GCS 15) from all controls with an AUC of 0.88. Mean GFAP levels in patients with negative CT scans versus those with positive CT scans were 0.335 ng/mL and 2.168 ng/mL, a highly significant difference with an AUC of 0.79.

The findings, if validated, suggest that early elevations of GFAP can be a potentially useful clinical tool in determining whether to image patients who are intoxicated or sedated, to admit or discharge patients from the ED, to assess severity of brain injury in a multiple trauma victim, to seek neurosurgical consultation and/or transfer to a neurosurgical facility, and to assess whether the patient can return to play or duty, she said.

Dr. Papa disclosed that she is a scientific consultant for Banyan Biomarkers, the company that is developing GFAP. However, she does not own stock or hold patents with the company. This study was funded by a grant from the Department of Defense and the National Institute of Neurological Disorders and Stroke.

BOSTON – The biomarker glial fibrillary acidic protein accurately distinguished between mild and moderate traumatic brain injury, between mild traumatic injury and controls, and between patients with and without intracranial lesions on CT in a prospective cohort study of emergency department patients with head injuries.

Glial fibrillary acidic protein (GFAP) is found in glial cells and is specific to the central nervous system. Found in both gray and white brain matter, it has recently been identified in serum, which makes it an attractive candidate as a clinical biomarker. Currently, the Glasgow Coma Scale (GCS) is the primary measure used to assess patients with head injury, but it can be influenced by intoxicants, medication, other injuries, or hypoperfusion and was not actually intended as an emergency department tool. "Really what we’d like is to develop some kind of biomarker that can be [measured] quickly and accurately, just like we do troponin for ischemia, or creatinine or bilirubin. Some type of blood test for the brain is our ultimate goal," said Dr. Linda Papa, director of academic clinical research, graduate medical education, Orlando Health, and an attending emergency physician at Orlando (Fla.) Regional Medical Center.

The study enrolled adult patients at three level 1 trauma centers who presented with mild or moderate blunt traumatic brain injury (TBI) and loss of consciousness or change in sensorium. Patients were enrolled from the ED and had blood samples collected within 4 hours of injury. All received CT scans. Control groups included patients with orthopedic trauma or motor vehicle trauma without head injury, and normal healthy people recruited from an ad. One aim of the study was to collect a large amount of normative data, she noted at the annual meeting of the Society for Academic Emergency Medicine.

A total of 307 patients were enrolled in the study, of whom 108 had a TBI. The TBI patients had a mean age of 39 years (range 18-89), and 65% were men. A total of 97 had GCS scores of 13-15 (mild), and 11 had GCS scores of 9-12 (moderate). Of the 97 with GCS 13-15, 24 (25%) had CT scans positive for intracranial lesions, and of the 11 patients with GCS scores 9-12, 8 (73%) had positive CTs. Controls included 176 normal individuals, 16 with non–head injury motor vehicle accidents, and 7 with orthopedic injuries.

Blood samples were drawn within a mean of 2.7 hours after injury. The GFAP biomarker first appeared in the serum within an hour (among those who had blood drawn that soon), increased until 3-4 hours, then leveled off. "It’s very interesting that so early in the course of injury, you can see a marker appearing in the blood," Dr. Papa commented.

Early GFAP levels were able to distinguish TBI patients from uninjured controls with an area under the curve (AUC) of 0.90 (1.0 is perfect), and differentiated those with mild TBI (GCS 15) from all controls with an AUC of 0.88. Mean GFAP levels in patients with negative CT scans versus those with positive CT scans were 0.335 ng/mL and 2.168 ng/mL, a highly significant difference with an AUC of 0.79.

The findings, if validated, suggest that early elevations of GFAP can be a potentially useful clinical tool in determining whether to image patients who are intoxicated or sedated, to admit or discharge patients from the ED, to assess severity of brain injury in a multiple trauma victim, to seek neurosurgical consultation and/or transfer to a neurosurgical facility, and to assess whether the patient can return to play or duty, she said.

Dr. Papa disclosed that she is a scientific consultant for Banyan Biomarkers, the company that is developing GFAP. However, she does not own stock or hold patents with the company. This study was funded by a grant from the Department of Defense and the National Institute of Neurological Disorders and Stroke.

BOSTON – The biomarker glial fibrillary acidic protein accurately distinguished between mild and moderate traumatic brain injury, between mild traumatic injury and controls, and between patients with and without intracranial lesions on CT in a prospective cohort study of emergency department patients with head injuries.

Glial fibrillary acidic protein (GFAP) is found in glial cells and is specific to the central nervous system. Found in both gray and white brain matter, it has recently been identified in serum, which makes it an attractive candidate as a clinical biomarker. Currently, the Glasgow Coma Scale (GCS) is the primary measure used to assess patients with head injury, but it can be influenced by intoxicants, medication, other injuries, or hypoperfusion and was not actually intended as an emergency department tool. "Really what we’d like is to develop some kind of biomarker that can be [measured] quickly and accurately, just like we do troponin for ischemia, or creatinine or bilirubin. Some type of blood test for the brain is our ultimate goal," said Dr. Linda Papa, director of academic clinical research, graduate medical education, Orlando Health, and an attending emergency physician at Orlando (Fla.) Regional Medical Center.

The study enrolled adult patients at three level 1 trauma centers who presented with mild or moderate blunt traumatic brain injury (TBI) and loss of consciousness or change in sensorium. Patients were enrolled from the ED and had blood samples collected within 4 hours of injury. All received CT scans. Control groups included patients with orthopedic trauma or motor vehicle trauma without head injury, and normal healthy people recruited from an ad. One aim of the study was to collect a large amount of normative data, she noted at the annual meeting of the Society for Academic Emergency Medicine.

A total of 307 patients were enrolled in the study, of whom 108 had a TBI. The TBI patients had a mean age of 39 years (range 18-89), and 65% were men. A total of 97 had GCS scores of 13-15 (mild), and 11 had GCS scores of 9-12 (moderate). Of the 97 with GCS 13-15, 24 (25%) had CT scans positive for intracranial lesions, and of the 11 patients with GCS scores 9-12, 8 (73%) had positive CTs. Controls included 176 normal individuals, 16 with non–head injury motor vehicle accidents, and 7 with orthopedic injuries.

Blood samples were drawn within a mean of 2.7 hours after injury. The GFAP biomarker first appeared in the serum within an hour (among those who had blood drawn that soon), increased until 3-4 hours, then leveled off. "It’s very interesting that so early in the course of injury, you can see a marker appearing in the blood," Dr. Papa commented.

Early GFAP levels were able to distinguish TBI patients from uninjured controls with an area under the curve (AUC) of 0.90 (1.0 is perfect), and differentiated those with mild TBI (GCS 15) from all controls with an AUC of 0.88. Mean GFAP levels in patients with negative CT scans versus those with positive CT scans were 0.335 ng/mL and 2.168 ng/mL, a highly significant difference with an AUC of 0.79.

The findings, if validated, suggest that early elevations of GFAP can be a potentially useful clinical tool in determining whether to image patients who are intoxicated or sedated, to admit or discharge patients from the ED, to assess severity of brain injury in a multiple trauma victim, to seek neurosurgical consultation and/or transfer to a neurosurgical facility, and to assess whether the patient can return to play or duty, she said.

Dr. Papa disclosed that she is a scientific consultant for Banyan Biomarkers, the company that is developing GFAP. However, she does not own stock or hold patents with the company. This study was funded by a grant from the Department of Defense and the National Institute of Neurological Disorders and Stroke.

BOSTON – The biomarker glial fibrillary acidic protein accurately distinguished between mild and moderate traumatic brain injury, between mild traumatic injury and controls, and between patients with and without intracranial lesions on CT in a prospective cohort study of emergency department patients with head injuries.

Glial fibrillary acidic protein (GFAP) is found in glial cells and is specific to the central nervous system. Found in both gray and white brain matter, it has recently been identified in serum, which makes it an attractive candidate as a clinical biomarker. Currently, the Glasgow Coma Scale (GCS) is the primary measure used to assess patients with head injury, but it can be influenced by intoxicants, medication, other injuries, or hypoperfusion and was not actually intended as an emergency department tool. "Really what we’d like is to develop some kind of biomarker that can be [measured] quickly and accurately, just like we do troponin for ischemia, or creatinine or bilirubin. Some type of blood test for the brain is our ultimate goal," said Dr. Linda Papa, director of academic clinical research, graduate medical education, Orlando Health, and an attending emergency physician at Orlando (Fla.) Regional Medical Center.

The study enrolled adult patients at three level 1 trauma centers who presented with mild or moderate blunt traumatic brain injury (TBI) and loss of consciousness or change in sensorium. Patients were enrolled from the ED and had blood samples collected within 4 hours of injury. All received CT scans. Control groups included patients with orthopedic trauma or motor vehicle trauma without head injury, and normal healthy people recruited from an ad. One aim of the study was to collect a large amount of normative data, she noted at the annual meeting of the Society for Academic Emergency Medicine.

A total of 307 patients were enrolled in the study, of whom 108 had a TBI. The TBI patients had a mean age of 39 years (range 18-89), and 65% were men. A total of 97 had GCS scores of 13-15 (mild), and 11 had GCS scores of 9-12 (moderate). Of the 97 with GCS 13-15, 24 (25%) had CT scans positive for intracranial lesions, and of the 11 patients with GCS scores 9-12, 8 (73%) had positive CTs. Controls included 176 normal individuals, 16 with non–head injury motor vehicle accidents, and 7 with orthopedic injuries.

Blood samples were drawn within a mean of 2.7 hours after injury. The GFAP biomarker first appeared in the serum within an hour (among those who had blood drawn that soon), increased until 3-4 hours, then leveled off. "It’s very interesting that so early in the course of injury, you can see a marker appearing in the blood," Dr. Papa commented.

Early GFAP levels were able to distinguish TBI patients from uninjured controls with an area under the curve (AUC) of 0.90 (1.0 is perfect), and differentiated those with mild TBI (GCS 15) from all controls with an AUC of 0.88. Mean GFAP levels in patients with negative CT scans versus those with positive CT scans were 0.335 ng/mL and 2.168 ng/mL, a highly significant difference with an AUC of 0.79.

The findings, if validated, suggest that early elevations of GFAP can be a potentially useful clinical tool in determining whether to image patients who are intoxicated or sedated, to admit or discharge patients from the ED, to assess severity of brain injury in a multiple trauma victim, to seek neurosurgical consultation and/or transfer to a neurosurgical facility, and to assess whether the patient can return to play or duty, she said.

Dr. Papa disclosed that she is a scientific consultant for Banyan Biomarkers, the company that is developing GFAP. However, she does not own stock or hold patents with the company. This study was funded by a grant from the Department of Defense and the National Institute of Neurological Disorders and Stroke.

BOSTON – The biomarker glial fibrillary acidic protein accurately distinguished between mild and moderate traumatic brain injury, between mild traumatic injury and controls, and between patients with and without intracranial lesions on CT in a prospective cohort study of emergency department patients with head injuries.

Glial fibrillary acidic protein (GFAP) is found in glial cells and is specific to the central nervous system. Found in both gray and white brain matter, it has recently been identified in serum, which makes it an attractive candidate as a clinical biomarker. Currently, the Glasgow Coma Scale (GCS) is the primary measure used to assess patients with head injury, but it can be influenced by intoxicants, medication, other injuries, or hypoperfusion and was not actually intended as an emergency department tool. "Really what we’d like is to develop some kind of biomarker that can be [measured] quickly and accurately, just like we do troponin for ischemia, or creatinine or bilirubin. Some type of blood test for the brain is our ultimate goal," said Dr. Linda Papa, director of academic clinical research, graduate medical education, Orlando Health, and an attending emergency physician at Orlando (Fla.) Regional Medical Center.

The study enrolled adult patients at three level 1 trauma centers who presented with mild or moderate blunt traumatic brain injury (TBI) and loss of consciousness or change in sensorium. Patients were enrolled from the ED and had blood samples collected within 4 hours of injury. All received CT scans. Control groups included patients with orthopedic trauma or motor vehicle trauma without head injury, and normal healthy people recruited from an ad. One aim of the study was to collect a large amount of normative data, she noted at the annual meeting of the Society for Academic Emergency Medicine.

A total of 307 patients were enrolled in the study, of whom 108 had a TBI. The TBI patients had a mean age of 39 years (range 18-89), and 65% were men. A total of 97 had GCS scores of 13-15 (mild), and 11 had GCS scores of 9-12 (moderate). Of the 97 with GCS 13-15, 24 (25%) had CT scans positive for intracranial lesions, and of the 11 patients with GCS scores 9-12, 8 (73%) had positive CTs. Controls included 176 normal individuals, 16 with non–head injury motor vehicle accidents, and 7 with orthopedic injuries.

Blood samples were drawn within a mean of 2.7 hours after injury. The GFAP biomarker first appeared in the serum within an hour (among those who had blood drawn that soon), increased until 3-4 hours, then leveled off. "It’s very interesting that so early in the course of injury, you can see a marker appearing in the blood," Dr. Papa commented.

Early GFAP levels were able to distinguish TBI patients from uninjured controls with an area under the curve (AUC) of 0.90 (1.0 is perfect), and differentiated those with mild TBI (GCS 15) from all controls with an AUC of 0.88. Mean GFAP levels in patients with negative CT scans versus those with positive CT scans were 0.335 ng/mL and 2.168 ng/mL, a highly significant difference with an AUC of 0.79.

The findings, if validated, suggest that early elevations of GFAP can be a potentially useful clinical tool in determining whether to image patients who are intoxicated or sedated, to admit or discharge patients from the ED, to assess severity of brain injury in a multiple trauma victim, to seek neurosurgical consultation and/or transfer to a neurosurgical facility, and to assess whether the patient can return to play or duty, she said.

Dr. Papa disclosed that she is a scientific consultant for Banyan Biomarkers, the company that is developing GFAP. However, she does not own stock or hold patents with the company. This study was funded by a grant from the Department of Defense and the National Institute of Neurological Disorders and Stroke.

BOSTON – The biomarker glial fibrillary acidic protein accurately distinguished between mild and moderate traumatic brain injury, between mild traumatic injury and controls, and between patients with and without intracranial lesions on CT in a prospective cohort study of emergency department patients with head injuries.

Glial fibrillary acidic protein (GFAP) is found in glial cells and is specific to the central nervous system. Found in both gray and white brain matter, it has recently been identified in serum, which makes it an attractive candidate as a clinical biomarker. Currently, the Glasgow Coma Scale (GCS) is the primary measure used to assess patients with head injury, but it can be influenced by intoxicants, medication, other injuries, or hypoperfusion and was not actually intended as an emergency department tool. "Really what we’d like is to develop some kind of biomarker that can be [measured] quickly and accurately, just like we do troponin for ischemia, or creatinine or bilirubin. Some type of blood test for the brain is our ultimate goal," said Dr. Linda Papa, director of academic clinical research, graduate medical education, Orlando Health, and an attending emergency physician at Orlando (Fla.) Regional Medical Center.

The study enrolled adult patients at three level 1 trauma centers who presented with mild or moderate blunt traumatic brain injury (TBI) and loss of consciousness or change in sensorium. Patients were enrolled from the ED and had blood samples collected within 4 hours of injury. All received CT scans. Control groups included patients with orthopedic trauma or motor vehicle trauma without head injury, and normal healthy people recruited from an ad. One aim of the study was to collect a large amount of normative data, she noted at the annual meeting of the Society for Academic Emergency Medicine.

A total of 307 patients were enrolled in the study, of whom 108 had a TBI. The TBI patients had a mean age of 39 years (range 18-89), and 65% were men. A total of 97 had GCS scores of 13-15 (mild), and 11 had GCS scores of 9-12 (moderate). Of the 97 with GCS 13-15, 24 (25%) had CT scans positive for intracranial lesions, and of the 11 patients with GCS scores 9-12, 8 (73%) had positive CTs. Controls included 176 normal individuals, 16 with non–head injury motor vehicle accidents, and 7 with orthopedic injuries.

Blood samples were drawn within a mean of 2.7 hours after injury. The GFAP biomarker first appeared in the serum within an hour (among those who had blood drawn that soon), increased until 3-4 hours, then leveled off. "It’s very interesting that so early in the course of injury, you can see a marker appearing in the blood," Dr. Papa commented.

Early GFAP levels were able to distinguish TBI patients from uninjured controls with an area under the curve (AUC) of 0.90 (1.0 is perfect), and differentiated those with mild TBI (GCS 15) from all controls with an AUC of 0.88. Mean GFAP levels in patients with negative CT scans versus those with positive CT scans were 0.335 ng/mL and 2.168 ng/mL, a highly significant difference with an AUC of 0.79.

The findings, if validated, suggest that early elevations of GFAP can be a potentially useful clinical tool in determining whether to image patients who are intoxicated or sedated, to admit or discharge patients from the ED, to assess severity of brain injury in a multiple trauma victim, to seek neurosurgical consultation and/or transfer to a neurosurgical facility, and to assess whether the patient can return to play or duty, she said.

Dr. Papa disclosed that she is a scientific consultant for Banyan Biomarkers, the company that is developing GFAP. However, she does not own stock or hold patents with the company. This study was funded by a grant from the Department of Defense and the National Institute of Neurological Disorders and Stroke.

BOSTON – The biomarker glial fibrillary acidic protein accurately distinguished between mild and moderate traumatic brain injury, between mild traumatic injury and controls, and between patients with and without intracranial lesions on CT in a prospective cohort study of emergency department patients with head injuries.

Glial fibrillary acidic protein (GFAP) is found in glial cells and is specific to the central nervous system. Found in both gray and white brain matter, it has recently been identified in serum, which makes it an attractive candidate as a clinical biomarker. Currently, the Glasgow Coma Scale (GCS) is the primary measure used to assess patients with head injury, but it can be influenced by intoxicants, medication, other injuries, or hypoperfusion and was not actually intended as an emergency department tool. "Really what we’d like is to develop some kind of biomarker that can be [measured] quickly and accurately, just like we do troponin for ischemia, or creatinine or bilirubin. Some type of blood test for the brain is our ultimate goal," said Dr. Linda Papa, director of academic clinical research, graduate medical education, Orlando Health, and an attending emergency physician at Orlando (Fla.) Regional Medical Center.

The study enrolled adult patients at three level 1 trauma centers who presented with mild or moderate blunt traumatic brain injury (TBI) and loss of consciousness or change in sensorium. Patients were enrolled from the ED and had blood samples collected within 4 hours of injury. All received CT scans. Control groups included patients with orthopedic trauma or motor vehicle trauma without head injury, and normal healthy people recruited from an ad. One aim of the study was to collect a large amount of normative data, she noted at the annual meeting of the Society for Academic Emergency Medicine.

A total of 307 patients were enrolled in the study, of whom 108 had a TBI. The TBI patients had a mean age of 39 years (range 18-89), and 65% were men. A total of 97 had GCS scores of 13-15 (mild), and 11 had GCS scores of 9-12 (moderate). Of the 97 with GCS 13-15, 24 (25%) had CT scans positive for intracranial lesions, and of the 11 patients with GCS scores 9-12, 8 (73%) had positive CTs. Controls included 176 normal individuals, 16 with non–head injury motor vehicle accidents, and 7 with orthopedic injuries.

Blood samples were drawn within a mean of 2.7 hours after injury. The GFAP biomarker first appeared in the serum within an hour (among those who had blood drawn that soon), increased until 3-4 hours, then leveled off. "It’s very interesting that so early in the course of injury, you can see a marker appearing in the blood," Dr. Papa commented.

Early GFAP levels were able to distinguish TBI patients from uninjured controls with an area under the curve (AUC) of 0.90 (1.0 is perfect), and differentiated those with mild TBI (GCS 15) from all controls with an AUC of 0.88. Mean GFAP levels in patients with negative CT scans versus those with positive CT scans were 0.335 ng/mL and 2.168 ng/mL, a highly significant difference with an AUC of 0.79.

The findings, if validated, suggest that early elevations of GFAP can be a potentially useful clinical tool in determining whether to image patients who are intoxicated or sedated, to admit or discharge patients from the ED, to assess severity of brain injury in a multiple trauma victim, to seek neurosurgical consultation and/or transfer to a neurosurgical facility, and to assess whether the patient can return to play or duty, she said.

Dr. Papa disclosed that she is a scientific consultant for Banyan Biomarkers, the company that is developing GFAP. However, she does not own stock or hold patents with the company. This study was funded by a grant from the Department of Defense and the National Institute of Neurological Disorders and Stroke.

SAN DIEGO – Recombinant human hyaluronidase combined with human regular insulin produced comparable glycemic responses to lispro insulin in a randomized open-label crossover study of 46 patients with well-controlled type 1 diabetes.

Recombinant human hyaluronidase (rHuPH20) is approved by the Food and Drug Administration to increase the dispersion and absorption of other injected drugs. This study investigated whether a combination of rHuPH20 with human regular insulin (Halozyme Therapeutics’ investigational Insulin-PH20) could produce glycemic control comparable to that of the currently available rapid-acting analogues. The ultimate aim is to combine it with those to make an even faster-acting analogue, Dr. Satish K. Garg said on June 25 at the annual scientific sessions of the American Diabetes Association.

“If we really want to achieve euglycemia in the postprandial phase, especially 1 and 2 hours after meals, we need an ultra–fast-acting insulin, and we don’t have that. So now, studies are on their way to look at using hyaluronidase with insulin lispro or another rapid-acting analogue to see if we can make it ultra–fast-acting insulin,” said Dr. Garg, professor of medicine and pediatrics at the University of Colorado, Denver.

The 46 patients had a mean age of 42 years, a mean body mass index of 26 kg/m², and a mean hemoglobin A_1c of 6.9%. They were randomized to either the Insulin-PH20 or insulin lispro for 2 consecutive 12-week periods, with twice-daily glargine as basal insulin in both groups. Forty-one of the 46 completed the trial.

The prespecified primary end point was a noninferiority margin of post-prandial glucose values not exceeding 21.6 mg/dL for three meals over 3 days. The difference in glycemic excursions between the two insulin formulations was 2.4 mg/dL, clearly meeting the end point, Dr. Garg said.

HbA_1c was maintained for both groups in the trial, 7.0% for Insulin-PH20 and 6.9% for lispro, meeting the commonly applied noninferiority margin of 0.4%. Continuous glucose monitoring during the last 2 weeks of each treatment period showed similar mean glucose values (153 vs. 143 mg/dL), with similar amounts of time spent in the target range of 70-130 mg/dL (39% vs. 44%).

Overall hypoglycemia, defined as blood glucose value of 70 mg/dL or below, was 24.1 vs. 22.4 events per patient-month for Insulin-PH20 and lispro, respectively, a nonsignificant difference. There were no significant changes in anti-insulin and anti-lispro antibodies, Dr. Garg noted.

Studies are now investigating the combination of rHuPH20 and currently available rapid-acting analogues in type 1 and type 2 diabetes patients to see whether the course of action can be accelerated further.

Dr. Garg disclosed that he has received grants and honoraria from Halozyme Therapeutics, Sanofi-Aventis, Novo-Nordisk, Dexcom, and Eli Lilly. 

SAN DIEGO – Recombinant human hyaluronidase combined with human regular insulin produced comparable glycemic responses to lispro insulin in a randomized open-label crossover study of 46 patients with well-controlled type 1 diabetes.

Recombinant human hyaluronidase (rHuPH20) is approved by the Food and Drug Administration to increase the dispersion and absorption of other injected drugs. This study investigated whether a combination of rHuPH20 with human regular insulin (Halozyme Therapeutics’ investigational Insulin-PH20) could produce glycemic control comparable to that of the currently available rapid-acting analogues. The ultimate aim is to combine it with those to make an even faster-acting analogue, Dr. Satish K. Garg said on June 25 at the annual scientific sessions of the American Diabetes Association.

“If we really want to achieve euglycemia in the postprandial phase, especially 1 and 2 hours after meals, we need an ultra–fast-acting insulin, and we don’t have that. So now, studies are on their way to look at using hyaluronidase with insulin lispro or another rapid-acting analogue to see if we can make it ultra–fast-acting insulin,” said Dr. Garg, professor of medicine and pediatrics at the University of Colorado, Denver.

The 46 patients had a mean age of 42 years, a mean body mass index of 26 kg/m², and a mean hemoglobin A_1c of 6.9%. They were randomized to either the Insulin-PH20 or insulin lispro for 2 consecutive 12-week periods, with twice-daily glargine as basal insulin in both groups. Forty-one of the 46 completed the trial.

The prespecified primary end point was a noninferiority margin of post-prandial glucose values not exceeding 21.6 mg/dL for three meals over 3 days. The difference in glycemic excursions between the two insulin formulations was 2.4 mg/dL, clearly meeting the end point, Dr. Garg said.

HbA_1c was maintained for both groups in the trial, 7.0% for Insulin-PH20 and 6.9% for lispro, meeting the commonly applied noninferiority margin of 0.4%. Continuous glucose monitoring during the last 2 weeks of each treatment period showed similar mean glucose values (153 vs. 143 mg/dL), with similar amounts of time spent in the target range of 70-130 mg/dL (39% vs. 44%).

Overall hypoglycemia, defined as blood glucose value of 70 mg/dL or below, was 24.1 vs. 22.4 events per patient-month for Insulin-PH20 and lispro, respectively, a nonsignificant difference. There were no significant changes in anti-insulin and anti-lispro antibodies, Dr. Garg noted.

Studies are now investigating the combination of rHuPH20 and currently available rapid-acting analogues in type 1 and type 2 diabetes patients to see whether the course of action can be accelerated further.

Dr. Garg disclosed that he has received grants and honoraria from Halozyme Therapeutics, Sanofi-Aventis, Novo-Nordisk, Dexcom, and Eli Lilly. 

SAN DIEGO – Recombinant human hyaluronidase combined with human regular insulin produced comparable glycemic responses to lispro insulin in a randomized open-label crossover study of 46 patients with well-controlled type 1 diabetes.

Recombinant human hyaluronidase (rHuPH20) is approved by the Food and Drug Administration to increase the dispersion and absorption of other injected drugs. This study investigated whether a combination of rHuPH20 with human regular insulin (Halozyme Therapeutics’ investigational Insulin-PH20) could produce glycemic control comparable to that of the currently available rapid-acting analogues. The ultimate aim is to combine it with those to make an even faster-acting analogue, Dr. Satish K. Garg said on June 25 at the annual scientific sessions of the American Diabetes Association.

“If we really want to achieve euglycemia in the postprandial phase, especially 1 and 2 hours after meals, we need an ultra–fast-acting insulin, and we don’t have that. So now, studies are on their way to look at using hyaluronidase with insulin lispro or another rapid-acting analogue to see if we can make it ultra–fast-acting insulin,” said Dr. Garg, professor of medicine and pediatrics at the University of Colorado, Denver.

The 46 patients had a mean age of 42 years, a mean body mass index of 26 kg/m², and a mean hemoglobin A_1c of 6.9%. They were randomized to either the Insulin-PH20 or insulin lispro for 2 consecutive 12-week periods, with twice-daily glargine as basal insulin in both groups. Forty-one of the 46 completed the trial.

The prespecified primary end point was a noninferiority margin of post-prandial glucose values not exceeding 21.6 mg/dL for three meals over 3 days. The difference in glycemic excursions between the two insulin formulations was 2.4 mg/dL, clearly meeting the end point, Dr. Garg said.

HbA_1c was maintained for both groups in the trial, 7.0% for Insulin-PH20 and 6.9% for lispro, meeting the commonly applied noninferiority margin of 0.4%. Continuous glucose monitoring during the last 2 weeks of each treatment period showed similar mean glucose values (153 vs. 143 mg/dL), with similar amounts of time spent in the target range of 70-130 mg/dL (39% vs. 44%).

Overall hypoglycemia, defined as blood glucose value of 70 mg/dL or below, was 24.1 vs. 22.4 events per patient-month for Insulin-PH20 and lispro, respectively, a nonsignificant difference. There were no significant changes in anti-insulin and anti-lispro antibodies, Dr. Garg noted.

Studies are now investigating the combination of rHuPH20 and currently available rapid-acting analogues in type 1 and type 2 diabetes patients to see whether the course of action can be accelerated further.

Dr. Garg disclosed that he has received grants and honoraria from Halozyme Therapeutics, Sanofi-Aventis, Novo-Nordisk, Dexcom, and Eli Lilly. 

SAN DIEGO – Elderly diabetes patients who received initial sulfonylurea monotherapy had a 33% greater risk for cardiovascular events at 2 years compared with those who were started on metformin therapy, according to a retrospective medical database review of 8,656 patients aged 65 and older.  

Cardiovascular disease events also happened sooner among the sulfonylurea patients, Ying Qui, Ph.D., reported on June 25  at the annual scientific sessions of the American Diabetes Association.

The study, funded by Merck Sharpe & Dohme, examined records from the GE Centricity Electronic Medical Records database for patients who received either sulfonylurea or metformin as their first diabetes drug during 2003-2007, remained on the drug for at least 90 days, and had no cardiovascular events recorded in the year prior to the prescription, reported Dr. Qui, who is with the company.

A total of 4,328 patients in each treatment group were included for analysis. They had a mean age of 49 years, and 48% were men. A propensity analysis controlled for factors that might have influenced the choice of prescribed medication. They found that the likelihood of having a CVD event in the subsequent 2 years was 14.8% in the sulfonylurea group versus 11.6% for those in the metformin group (hazard ratio 1.33, P < 0.001).

The sulfonylurea group had a significantly greater likelihood of developing both ischemic heart disease (7.1% vs. 5.3%) and congestive heart failure (3.4% vs. 1.9%). The incidences of myocardial infarction, stroke, transient ischemic attack, and peripheral arterial disease did not differ significantly between the two groups.

In the cohort of 6,096 patients with 3 years of follow-up, the sulfonylurea group continued to have a higher risk for CVD events, with a hazard ratio of 1.20. The time to first cardiovascular event was significantly shorter in the sulfonylurea group, with hazard ratios of 1.22 compared with metformin at 2 years and 1.17 at 3 years, Dr. Qui reported.

Male gender and older age was also associated with greater risk for CVD events, she said. 

SAN DIEGO – Elderly diabetes patients who received initial sulfonylurea monotherapy had a 33% greater risk for cardiovascular events at 2 years compared with those who were started on metformin therapy, according to a retrospective medical database review of 8,656 patients aged 65 and older.  

Cardiovascular disease events also happened sooner among the sulfonylurea patients, Ying Qui, Ph.D., reported on June 25  at the annual scientific sessions of the American Diabetes Association.

The study, funded by Merck Sharpe & Dohme, examined records from the GE Centricity Electronic Medical Records database for patients who received either sulfonylurea or metformin as their first diabetes drug during 2003-2007, remained on the drug for at least 90 days, and had no cardiovascular events recorded in the year prior to the prescription, reported Dr. Qui, who is with the company.

A total of 4,328 patients in each treatment group were included for analysis. They had a mean age of 49 years, and 48% were men. A propensity analysis controlled for factors that might have influenced the choice of prescribed medication. They found that the likelihood of having a CVD event in the subsequent 2 years was 14.8% in the sulfonylurea group versus 11.6% for those in the metformin group (hazard ratio 1.33, P < 0.001).

The sulfonylurea group had a significantly greater likelihood of developing both ischemic heart disease (7.1% vs. 5.3%) and congestive heart failure (3.4% vs. 1.9%). The incidences of myocardial infarction, stroke, transient ischemic attack, and peripheral arterial disease did not differ significantly between the two groups.

In the cohort of 6,096 patients with 3 years of follow-up, the sulfonylurea group continued to have a higher risk for CVD events, with a hazard ratio of 1.20. The time to first cardiovascular event was significantly shorter in the sulfonylurea group, with hazard ratios of 1.22 compared with metformin at 2 years and 1.17 at 3 years, Dr. Qui reported.

Male gender and older age was also associated with greater risk for CVD events, she said. 

SAN DIEGO – Elderly diabetes patients who received initial sulfonylurea monotherapy had a 33% greater risk for cardiovascular events at 2 years compared with those who were started on metformin therapy, according to a retrospective medical database review of 8,656 patients aged 65 and older.  

Cardiovascular disease events also happened sooner among the sulfonylurea patients, Ying Qui, Ph.D., reported on June 25  at the annual scientific sessions of the American Diabetes Association.

The study, funded by Merck Sharpe & Dohme, examined records from the GE Centricity Electronic Medical Records database for patients who received either sulfonylurea or metformin as their first diabetes drug during 2003-2007, remained on the drug for at least 90 days, and had no cardiovascular events recorded in the year prior to the prescription, reported Dr. Qui, who is with the company.

A total of 4,328 patients in each treatment group were included for analysis. They had a mean age of 49 years, and 48% were men. A propensity analysis controlled for factors that might have influenced the choice of prescribed medication. They found that the likelihood of having a CVD event in the subsequent 2 years was 14.8% in the sulfonylurea group versus 11.6% for those in the metformin group (hazard ratio 1.33, P < 0.001).

The sulfonylurea group had a significantly greater likelihood of developing both ischemic heart disease (7.1% vs. 5.3%) and congestive heart failure (3.4% vs. 1.9%). The incidences of myocardial infarction, stroke, transient ischemic attack, and peripheral arterial disease did not differ significantly between the two groups.

In the cohort of 6,096 patients with 3 years of follow-up, the sulfonylurea group continued to have a higher risk for CVD events, with a hazard ratio of 1.20. The time to first cardiovascular event was significantly shorter in the sulfonylurea group, with hazard ratios of 1.22 compared with metformin at 2 years and 1.17 at 3 years, Dr. Qui reported.

Male gender and older age was also associated with greater risk for CVD events, she said. 

SAN DIEGO – Elderly diabetes patients who received initial sulfonylurea monotherapy had a 33% greater risk for cardiovascular events at 2 years compared with those who were started on metformin therapy, according to a retrospective medical database review of 8,656 patients aged 65 and older.  

Cardiovascular disease events also happened sooner among the sulfonylurea patients, Ying Qui, Ph.D., reported on June 25  at the annual scientific sessions of the American Diabetes Association.

The study, funded by Merck Sharpe & Dohme, examined records from the GE Centricity Electronic Medical Records database for patients who received either sulfonylurea or metformin as their first diabetes drug during 2003-2007, remained on the drug for at least 90 days, and had no cardiovascular events recorded in the year prior to the prescription, reported Dr. Qui, who is with the company.

A total of 4,328 patients in each treatment group were included for analysis. They had a mean age of 49 years, and 48% were men. A propensity analysis controlled for factors that might have influenced the choice of prescribed medication. They found that the likelihood of having a CVD event in the subsequent 2 years was 14.8% in the sulfonylurea group versus 11.6% for those in the metformin group (hazard ratio 1.33, P < 0.001).

The sulfonylurea group had a significantly greater likelihood of developing both ischemic heart disease (7.1% vs. 5.3%) and congestive heart failure (3.4% vs. 1.9%). The incidences of myocardial infarction, stroke, transient ischemic attack, and peripheral arterial disease did not differ significantly between the two groups.

In the cohort of 6,096 patients with 3 years of follow-up, the sulfonylurea group continued to have a higher risk for CVD events, with a hazard ratio of 1.20. The time to first cardiovascular event was significantly shorter in the sulfonylurea group, with hazard ratios of 1.22 compared with metformin at 2 years and 1.17 at 3 years, Dr. Qui reported.

Male gender and older age was also associated with greater risk for CVD events, she said. 

SAN DIEGO – Elderly diabetes patients who received initial sulfonylurea monotherapy had a 33% greater risk for cardiovascular events at 2 years compared with those who were started on metformin therapy, according to a retrospective medical database review of 8,656 patients aged 65 and older.  

Cardiovascular disease events also happened sooner among the sulfonylurea patients, Ying Qui, Ph.D., reported on June 25  at the annual scientific sessions of the American Diabetes Association.

The study, funded by Merck Sharpe & Dohme, examined records from the GE Centricity Electronic Medical Records database for patients who received either sulfonylurea or metformin as their first diabetes drug during 2003-2007, remained on the drug for at least 90 days, and had no cardiovascular events recorded in the year prior to the prescription, reported Dr. Qui, who is with the company.

A total of 4,328 patients in each treatment group were included for analysis. They had a mean age of 49 years, and 48% were men. A propensity analysis controlled for factors that might have influenced the choice of prescribed medication. They found that the likelihood of having a CVD event in the subsequent 2 years was 14.8% in the sulfonylurea group versus 11.6% for those in the metformin group (hazard ratio 1.33, P < 0.001).

The sulfonylurea group had a significantly greater likelihood of developing both ischemic heart disease (7.1% vs. 5.3%) and congestive heart failure (3.4% vs. 1.9%). The incidences of myocardial infarction, stroke, transient ischemic attack, and peripheral arterial disease did not differ significantly between the two groups.

In the cohort of 6,096 patients with 3 years of follow-up, the sulfonylurea group continued to have a higher risk for CVD events, with a hazard ratio of 1.20. The time to first cardiovascular event was significantly shorter in the sulfonylurea group, with hazard ratios of 1.22 compared with metformin at 2 years and 1.17 at 3 years, Dr. Qui reported.

Male gender and older age was also associated with greater risk for CVD events, she said. 

SAN DIEGO – Elderly diabetes patients who received initial sulfonylurea monotherapy had a 33% greater risk for cardiovascular events at 2 years compared with those who were started on metformin therapy, according to a retrospective medical database review of 8,656 patients aged 65 and older.  

Cardiovascular disease events also happened sooner among the sulfonylurea patients, Ying Qui, Ph.D., reported on June 25  at the annual scientific sessions of the American Diabetes Association.

The study, funded by Merck Sharpe & Dohme, examined records from the GE Centricity Electronic Medical Records database for patients who received either sulfonylurea or metformin as their first diabetes drug during 2003-2007, remained on the drug for at least 90 days, and had no cardiovascular events recorded in the year prior to the prescription, reported Dr. Qui, who is with the company.

A total of 4,328 patients in each treatment group were included for analysis. They had a mean age of 49 years, and 48% were men. A propensity analysis controlled for factors that might have influenced the choice of prescribed medication. They found that the likelihood of having a CVD event in the subsequent 2 years was 14.8% in the sulfonylurea group versus 11.6% for those in the metformin group (hazard ratio 1.33, P < 0.001).

The sulfonylurea group had a significantly greater likelihood of developing both ischemic heart disease (7.1% vs. 5.3%) and congestive heart failure (3.4% vs. 1.9%). The incidences of myocardial infarction, stroke, transient ischemic attack, and peripheral arterial disease did not differ significantly between the two groups.

In the cohort of 6,096 patients with 3 years of follow-up, the sulfonylurea group continued to have a higher risk for CVD events, with a hazard ratio of 1.20. The time to first cardiovascular event was significantly shorter in the sulfonylurea group, with hazard ratios of 1.22 compared with metformin at 2 years and 1.17 at 3 years, Dr. Qui reported.

Male gender and older age was also associated with greater risk for CVD events, she said. 

SAN DIEGO – Elderly diabetes patients who received initial sulfonylurea monotherapy had a 33% greater risk for cardiovascular events at 2 years compared with those who were started on metformin therapy, according to a retrospective medical database review of 8,656 patients aged 65 and older.  

Cardiovascular disease events also happened sooner among the sulfonylurea patients, Ying Qui, Ph.D., reported on June 25  at the annual scientific sessions of the American Diabetes Association.

The study, funded by Merck Sharpe & Dohme, examined records from the GE Centricity Electronic Medical Records database for patients who received either sulfonylurea or metformin as their first diabetes drug during 2003-2007, remained on the drug for at least 90 days, and had no cardiovascular events recorded in the year prior to the prescription, reported Dr. Qui, who is with the company.

A total of 4,328 patients in each treatment group were included for analysis. They had a mean age of 49 years, and 48% were men. A propensity analysis controlled for factors that might have influenced the choice of prescribed medication. They found that the likelihood of having a CVD event in the subsequent 2 years was 14.8% in the sulfonylurea group versus 11.6% for those in the metformin group (hazard ratio 1.33, P < 0.001).

The sulfonylurea group had a significantly greater likelihood of developing both ischemic heart disease (7.1% vs. 5.3%) and congestive heart failure (3.4% vs. 1.9%). The incidences of myocardial infarction, stroke, transient ischemic attack, and peripheral arterial disease did not differ significantly between the two groups.

In the cohort of 6,096 patients with 3 years of follow-up, the sulfonylurea group continued to have a higher risk for CVD events, with a hazard ratio of 1.20. The time to first cardiovascular event was significantly shorter in the sulfonylurea group, with hazard ratios of 1.22 compared with metformin at 2 years and 1.17 at 3 years, Dr. Qui reported.

Male gender and older age was also associated with greater risk for CVD events, she said. 

SAN DIEGO – Elderly diabetes patients who received initial sulfonylurea monotherapy had a 33% greater risk for cardiovascular events at 2 years compared with those who were started on metformin therapy, according to a retrospective medical database review of 8,656 patients aged 65 and older.  

Cardiovascular disease events also happened sooner among the sulfonylurea patients, Ying Qui, Ph.D., reported on June 25  at the annual scientific sessions of the American Diabetes Association.

The study, funded by Merck Sharpe & Dohme, examined records from the GE Centricity Electronic Medical Records database for patients who received either sulfonylurea or metformin as their first diabetes drug during 2003-2007, remained on the drug for at least 90 days, and had no cardiovascular events recorded in the year prior to the prescription, reported Dr. Qui, who is with the company.

A total of 4,328 patients in each treatment group were included for analysis. They had a mean age of 49 years, and 48% were men. A propensity analysis controlled for factors that might have influenced the choice of prescribed medication. They found that the likelihood of having a CVD event in the subsequent 2 years was 14.8% in the sulfonylurea group versus 11.6% for those in the metformin group (hazard ratio 1.33, P < 0.001).

The sulfonylurea group had a significantly greater likelihood of developing both ischemic heart disease (7.1% vs. 5.3%) and congestive heart failure (3.4% vs. 1.9%). The incidences of myocardial infarction, stroke, transient ischemic attack, and peripheral arterial disease did not differ significantly between the two groups.

In the cohort of 6,096 patients with 3 years of follow-up, the sulfonylurea group continued to have a higher risk for CVD events, with a hazard ratio of 1.20. The time to first cardiovascular event was significantly shorter in the sulfonylurea group, with hazard ratios of 1.22 compared with metformin at 2 years and 1.17 at 3 years, Dr. Qui reported.

Male gender and older age was also associated with greater risk for CVD events, she said. 

SAN DIEGO – Elderly diabetes patients who received initial sulfonylurea monotherapy had a 33% greater risk for cardiovascular events at 2 years compared with those who were started on metformin therapy, according to a retrospective medical database review of 8,656 patients aged 65 and older.  

Cardiovascular disease events also happened sooner among the sulfonylurea patients, Ying Qui, Ph.D., reported on June 25  at the annual scientific sessions of the American Diabetes Association.

The study, funded by Merck Sharpe & Dohme, examined records from the GE Centricity Electronic Medical Records database for patients who received either sulfonylurea or metformin as their first diabetes drug during 2003-2007, remained on the drug for at least 90 days, and had no cardiovascular events recorded in the year prior to the prescription, reported Dr. Qui, who is with the company.

A total of 4,328 patients in each treatment group were included for analysis. They had a mean age of 49 years, and 48% were men. A propensity analysis controlled for factors that might have influenced the choice of prescribed medication. They found that the likelihood of having a CVD event in the subsequent 2 years was 14.8% in the sulfonylurea group versus 11.6% for those in the metformin group (hazard ratio 1.33, P < 0.001).

The sulfonylurea group had a significantly greater likelihood of developing both ischemic heart disease (7.1% vs. 5.3%) and congestive heart failure (3.4% vs. 1.9%). The incidences of myocardial infarction, stroke, transient ischemic attack, and peripheral arterial disease did not differ significantly between the two groups.

In the cohort of 6,096 patients with 3 years of follow-up, the sulfonylurea group continued to have a higher risk for CVD events, with a hazard ratio of 1.20. The time to first cardiovascular event was significantly shorter in the sulfonylurea group, with hazard ratios of 1.22 compared with metformin at 2 years and 1.17 at 3 years, Dr. Qui reported.

Male gender and older age was also associated with greater risk for CVD events, she said. 

SAN DIEGO – Early, multifactorial intervention in patients who were diagnosed with type 2 diabetes through screening reduced the incidence of cardiovascular events and death, albeit nonsignificantly, in a large, randomized controlled trial.

At the time of diagnosis, many patients with type 2 diabetes already have evidence of diabetic complications and potentially modifiable cardiovascular risk factors. Modeling studies have indicated that routine diabetes screening might be an efficient use of resources, but there has been no previous evidence from trials showing whether early intensive multifactorial treatment improves outcomes following detection by screening, said Dr. Simon J. Griffin, of the MRC Epidemiology Unit, Institute of Metabolic Science, Cambridge, England, and his associates.

Results of the Anglo-Danish-Dutch Study of Intensive Treatment in People With Screen Detected Diabetes in Primary Care (ADDITION-Europe) were presented by Dr. Griffen at the annual scientific sessions of the American Diabetes Association and simultaneously published online June 25 in the Lancet (2011 June 25 [doi:10.1016/S0140-6736(11)60698-3]).

The study used a cluster design, in which 343 general practices were randomized from April 2001 to December 2006 to routine diabetes care or intensive multifactorial treatment. A total of 157 of the practices randomized to routine care and 161 to intensive care completed screening and included eligible patients. Screening involved either calculation of a risk score followed by capillary glucose testing, or an oral glucose tolerance test.

The intensive-treatment intervention involved the stepwise addition of medications and promotion of healthy lifestyles aimed at achieving target-driven and guideline-driven management of hyperglycemia, blood pressure, and cholesterol levels. The same approach was used across all centers, although final decisions about prescriptions, including choice of individual drugs, were made by physicians and patients, Dr. Griffen and his associates said.

In all, 3,057 screen-identified patients aged 40-69 years were included. The mean follow-up period was 5.3 years, during which 238 first cardiovascular events occurred. The primary end point, a composite of cardiovascular events, occurred in 8.5% of the routine-care patients and 7.2% of the intervention group. The difference was statistically nonsignificant, with a hazard ratio (HR) of 0.83.

Trends were in favor of the multifactorial intervention for the composite components cardiovascular death, myocardial infarction, stroke, revascularization, and total mortality, but none of these achieved statistical significance. Differences were greatest for myocardial infarction (2.3% vs. 1.7%; HR, 0.7) and smallest for stroke (1.4% vs. 1.3%; HR, 0.98). Another component, amputation, did not occur as a first event in either group.

In both groups, more patients had values below target thresholds for hemoglobin A_1c concentrations, blood pressure, and cholesterol concentrations at follow-up than at baseline, but the proportion of patients meeting the targets was higher in the intensive-treatment group than in the routine-care group. The proportions of patients reporting hypoglycemia did not differ, the investigators said.

One possible explanation for the lack of a stronger effect is that the trial took place at a time of improved diabetes care delivery in general practice, which might have minimized the differences between the groups. At follow-up, mean HbA_1c values were 6.7% for routine care and 6.6% for intensive treatment, down from 7.0% in both groups at baseline. Systolic blood pressure was 138.1 mm Hg with routine care and 134.8 mm Hg with intensive intervention, down from 149.8 and 148.5, respectively.

It’s also possible that the follow-up wasn’t long enough. The event rate was lower than expected at 5 years, but the values appeared to diverge at about 4 years, suggesting that further follow-up is justified to test whether early intensive multifactorial treatment reduces cardiovascular risk in the long term, the investigators concluded.

The trial was given unrestricted grants from Novo Nordisk AS, Novo Nordisk Scandinavia AB, Novo Nordisk UK, ASTRA Denmark, Pfizer Denmark, GlaxoSmithKline Pharma Denmark, Servier Denmark, and HemoCue Denmark.

SAN DIEGO – Early, multifactorial intervention in patients who were diagnosed with type 2 diabetes through screening reduced the incidence of cardiovascular events and death, albeit nonsignificantly, in a large, randomized controlled trial.

At the time of diagnosis, many patients with type 2 diabetes already have evidence of diabetic complications and potentially modifiable cardiovascular risk factors. Modeling studies have indicated that routine diabetes screening might be an efficient use of resources, but there has been no previous evidence from trials showing whether early intensive multifactorial treatment improves outcomes following detection by screening, said Dr. Simon J. Griffin, of the MRC Epidemiology Unit, Institute of Metabolic Science, Cambridge, England, and his associates.

Results of the Anglo-Danish-Dutch Study of Intensive Treatment in People With Screen Detected Diabetes in Primary Care (ADDITION-Europe) were presented by Dr. Griffen at the annual scientific sessions of the American Diabetes Association and simultaneously published online June 25 in the Lancet (2011 June 25 [doi:10.1016/S0140-6736(11)60698-3]).

The study used a cluster design, in which 343 general practices were randomized from April 2001 to December 2006 to routine diabetes care or intensive multifactorial treatment. A total of 157 of the practices randomized to routine care and 161 to intensive care completed screening and included eligible patients. Screening involved either calculation of a risk score followed by capillary glucose testing, or an oral glucose tolerance test.

The intensive-treatment intervention involved the stepwise addition of medications and promotion of healthy lifestyles aimed at achieving target-driven and guideline-driven management of hyperglycemia, blood pressure, and cholesterol levels. The same approach was used across all centers, although final decisions about prescriptions, including choice of individual drugs, were made by physicians and patients, Dr. Griffen and his associates said.

In all, 3,057 screen-identified patients aged 40-69 years were included. The mean follow-up period was 5.3 years, during which 238 first cardiovascular events occurred. The primary end point, a composite of cardiovascular events, occurred in 8.5% of the routine-care patients and 7.2% of the intervention group. The difference was statistically nonsignificant, with a hazard ratio (HR) of 0.83.

Trends were in favor of the multifactorial intervention for the composite components cardiovascular death, myocardial infarction, stroke, revascularization, and total mortality, but none of these achieved statistical significance. Differences were greatest for myocardial infarction (2.3% vs. 1.7%; HR, 0.7) and smallest for stroke (1.4% vs. 1.3%; HR, 0.98). Another component, amputation, did not occur as a first event in either group.

In both groups, more patients had values below target thresholds for hemoglobin A_1c concentrations, blood pressure, and cholesterol concentrations at follow-up than at baseline, but the proportion of patients meeting the targets was higher in the intensive-treatment group than in the routine-care group. The proportions of patients reporting hypoglycemia did not differ, the investigators said.

One possible explanation for the lack of a stronger effect is that the trial took place at a time of improved diabetes care delivery in general practice, which might have minimized the differences between the groups. At follow-up, mean HbA_1c values were 6.7% for routine care and 6.6% for intensive treatment, down from 7.0% in both groups at baseline. Systolic blood pressure was 138.1 mm Hg with routine care and 134.8 mm Hg with intensive intervention, down from 149.8 and 148.5, respectively.

It’s also possible that the follow-up wasn’t long enough. The event rate was lower than expected at 5 years, but the values appeared to diverge at about 4 years, suggesting that further follow-up is justified to test whether early intensive multifactorial treatment reduces cardiovascular risk in the long term, the investigators concluded.

The trial was given unrestricted grants from Novo Nordisk AS, Novo Nordisk Scandinavia AB, Novo Nordisk UK, ASTRA Denmark, Pfizer Denmark, GlaxoSmithKline Pharma Denmark, Servier Denmark, and HemoCue Denmark.

SAN DIEGO – Early, multifactorial intervention in patients who were diagnosed with type 2 diabetes through screening reduced the incidence of cardiovascular events and death, albeit nonsignificantly, in a large, randomized controlled trial.

At the time of diagnosis, many patients with type 2 diabetes already have evidence of diabetic complications and potentially modifiable cardiovascular risk factors. Modeling studies have indicated that routine diabetes screening might be an efficient use of resources, but there has been no previous evidence from trials showing whether early intensive multifactorial treatment improves outcomes following detection by screening, said Dr. Simon J. Griffin, of the MRC Epidemiology Unit, Institute of Metabolic Science, Cambridge, England, and his associates.

Results of the Anglo-Danish-Dutch Study of Intensive Treatment in People With Screen Detected Diabetes in Primary Care (ADDITION-Europe) were presented by Dr. Griffen at the annual scientific sessions of the American Diabetes Association and simultaneously published online June 25 in the Lancet (2011 June 25 [doi:10.1016/S0140-6736(11)60698-3]).

The study used a cluster design, in which 343 general practices were randomized from April 2001 to December 2006 to routine diabetes care or intensive multifactorial treatment. A total of 157 of the practices randomized to routine care and 161 to intensive care completed screening and included eligible patients. Screening involved either calculation of a risk score followed by capillary glucose testing, or an oral glucose tolerance test.

The intensive-treatment intervention involved the stepwise addition of medications and promotion of healthy lifestyles aimed at achieving target-driven and guideline-driven management of hyperglycemia, blood pressure, and cholesterol levels. The same approach was used across all centers, although final decisions about prescriptions, including choice of individual drugs, were made by physicians and patients, Dr. Griffen and his associates said.

In all, 3,057 screen-identified patients aged 40-69 years were included. The mean follow-up period was 5.3 years, during which 238 first cardiovascular events occurred. The primary end point, a composite of cardiovascular events, occurred in 8.5% of the routine-care patients and 7.2% of the intervention group. The difference was statistically nonsignificant, with a hazard ratio (HR) of 0.83.

Trends were in favor of the multifactorial intervention for the composite components cardiovascular death, myocardial infarction, stroke, revascularization, and total mortality, but none of these achieved statistical significance. Differences were greatest for myocardial infarction (2.3% vs. 1.7%; HR, 0.7) and smallest for stroke (1.4% vs. 1.3%; HR, 0.98). Another component, amputation, did not occur as a first event in either group.

In both groups, more patients had values below target thresholds for hemoglobin A_1c concentrations, blood pressure, and cholesterol concentrations at follow-up than at baseline, but the proportion of patients meeting the targets was higher in the intensive-treatment group than in the routine-care group. The proportions of patients reporting hypoglycemia did not differ, the investigators said.

One possible explanation for the lack of a stronger effect is that the trial took place at a time of improved diabetes care delivery in general practice, which might have minimized the differences between the groups. At follow-up, mean HbA_1c values were 6.7% for routine care and 6.6% for intensive treatment, down from 7.0% in both groups at baseline. Systolic blood pressure was 138.1 mm Hg with routine care and 134.8 mm Hg with intensive intervention, down from 149.8 and 148.5, respectively.

It’s also possible that the follow-up wasn’t long enough. The event rate was lower than expected at 5 years, but the values appeared to diverge at about 4 years, suggesting that further follow-up is justified to test whether early intensive multifactorial treatment reduces cardiovascular risk in the long term, the investigators concluded.

The trial was given unrestricted grants from Novo Nordisk AS, Novo Nordisk Scandinavia AB, Novo Nordisk UK, ASTRA Denmark, Pfizer Denmark, GlaxoSmithKline Pharma Denmark, Servier Denmark, and HemoCue Denmark.

SAN DIEGO – Early, multifactorial intervention in patients who were diagnosed with type 2 diabetes through screening reduced the incidence of cardiovascular events and death, albeit nonsignificantly, in a large, randomized controlled trial.

At the time of diagnosis, many patients with type 2 diabetes already have evidence of diabetic complications and potentially modifiable cardiovascular risk factors. Modeling studies have indicated that routine diabetes screening might be an efficient use of resources, but there has been no previous evidence from trials showing whether early intensive multifactorial treatment improves outcomes following detection by screening, said Dr. Simon J. Griffin, of the MRC Epidemiology Unit, Institute of Metabolic Science, Cambridge, England, and his associates.

Results of the Anglo-Danish-Dutch Study of Intensive Treatment in People With Screen Detected Diabetes in Primary Care (ADDITION-Europe) were presented by Dr. Griffen at the annual scientific sessions of the American Diabetes Association and simultaneously published online June 25 in the Lancet (2011 June 25 [doi:10.1016/S0140-6736(11)60698-3]).

The study used a cluster design, in which 343 general practices were randomized from April 2001 to December 2006 to routine diabetes care or intensive multifactorial treatment. A total of 157 of the practices randomized to routine care and 161 to intensive care completed screening and included eligible patients. Screening involved either calculation of a risk score followed by capillary glucose testing, or an oral glucose tolerance test.

The intensive-treatment intervention involved the stepwise addition of medications and promotion of healthy lifestyles aimed at achieving target-driven and guideline-driven management of hyperglycemia, blood pressure, and cholesterol levels. The same approach was used across all centers, although final decisions about prescriptions, including choice of individual drugs, were made by physicians and patients, Dr. Griffen and his associates said.

In all, 3,057 screen-identified patients aged 40-69 years were included. The mean follow-up period was 5.3 years, during which 238 first cardiovascular events occurred. The primary end point, a composite of cardiovascular events, occurred in 8.5% of the routine-care patients and 7.2% of the intervention group. The difference was statistically nonsignificant, with a hazard ratio (HR) of 0.83.

Trends were in favor of the multifactorial intervention for the composite components cardiovascular death, myocardial infarction, stroke, revascularization, and total mortality, but none of these achieved statistical significance. Differences were greatest for myocardial infarction (2.3% vs. 1.7%; HR, 0.7) and smallest for stroke (1.4% vs. 1.3%; HR, 0.98). Another component, amputation, did not occur as a first event in either group.

In both groups, more patients had values below target thresholds for hemoglobin A_1c concentrations, blood pressure, and cholesterol concentrations at follow-up than at baseline, but the proportion of patients meeting the targets was higher in the intensive-treatment group than in the routine-care group. The proportions of patients reporting hypoglycemia did not differ, the investigators said.

One possible explanation for the lack of a stronger effect is that the trial took place at a time of improved diabetes care delivery in general practice, which might have minimized the differences between the groups. At follow-up, mean HbA_1c values were 6.7% for routine care and 6.6% for intensive treatment, down from 7.0% in both groups at baseline. Systolic blood pressure was 138.1 mm Hg with routine care and 134.8 mm Hg with intensive intervention, down from 149.8 and 148.5, respectively.

It’s also possible that the follow-up wasn’t long enough. The event rate was lower than expected at 5 years, but the values appeared to diverge at about 4 years, suggesting that further follow-up is justified to test whether early intensive multifactorial treatment reduces cardiovascular risk in the long term, the investigators concluded.

The trial was given unrestricted grants from Novo Nordisk AS, Novo Nordisk Scandinavia AB, Novo Nordisk UK, ASTRA Denmark, Pfizer Denmark, GlaxoSmithKline Pharma Denmark, Servier Denmark, and HemoCue Denmark.

SAN DIEGO – Early, multifactorial intervention in patients who were diagnosed with type 2 diabetes through screening reduced the incidence of cardiovascular events and death, albeit nonsignificantly, in a large, randomized controlled trial.

At the time of diagnosis, many patients with type 2 diabetes already have evidence of diabetic complications and potentially modifiable cardiovascular risk factors. Modeling studies have indicated that routine diabetes screening might be an efficient use of resources, but there has been no previous evidence from trials showing whether early intensive multifactorial treatment improves outcomes following detection by screening, said Dr. Simon J. Griffin, of the MRC Epidemiology Unit, Institute of Metabolic Science, Cambridge, England, and his associates.

Results of the Anglo-Danish-Dutch Study of Intensive Treatment in People With Screen Detected Diabetes in Primary Care (ADDITION-Europe) were presented by Dr. Griffen at the annual scientific sessions of the American Diabetes Association and simultaneously published online June 25 in the Lancet (2011 June 25 [doi:10.1016/S0140-6736(11)60698-3]).

The study used a cluster design, in which 343 general practices were randomized from April 2001 to December 2006 to routine diabetes care or intensive multifactorial treatment. A total of 157 of the practices randomized to routine care and 161 to intensive care completed screening and included eligible patients. Screening involved either calculation of a risk score followed by capillary glucose testing, or an oral glucose tolerance test.

The intensive-treatment intervention involved the stepwise addition of medications and promotion of healthy lifestyles aimed at achieving target-driven and guideline-driven management of hyperglycemia, blood pressure, and cholesterol levels. The same approach was used across all centers, although final decisions about prescriptions, including choice of individual drugs, were made by physicians and patients, Dr. Griffen and his associates said.

In all, 3,057 screen-identified patients aged 40-69 years were included. The mean follow-up period was 5.3 years, during which 238 first cardiovascular events occurred. The primary end point, a composite of cardiovascular events, occurred in 8.5% of the routine-care patients and 7.2% of the intervention group. The difference was statistically nonsignificant, with a hazard ratio (HR) of 0.83.

Trends were in favor of the multifactorial intervention for the composite components cardiovascular death, myocardial infarction, stroke, revascularization, and total mortality, but none of these achieved statistical significance. Differences were greatest for myocardial infarction (2.3% vs. 1.7%; HR, 0.7) and smallest for stroke (1.4% vs. 1.3%; HR, 0.98). Another component, amputation, did not occur as a first event in either group.

In both groups, more patients had values below target thresholds for hemoglobin A_1c concentrations, blood pressure, and cholesterol concentrations at follow-up than at baseline, but the proportion of patients meeting the targets was higher in the intensive-treatment group than in the routine-care group. The proportions of patients reporting hypoglycemia did not differ, the investigators said.

One possible explanation for the lack of a stronger effect is that the trial took place at a time of improved diabetes care delivery in general practice, which might have minimized the differences between the groups. At follow-up, mean HbA_1c values were 6.7% for routine care and 6.6% for intensive treatment, down from 7.0% in both groups at baseline. Systolic blood pressure was 138.1 mm Hg with routine care and 134.8 mm Hg with intensive intervention, down from 149.8 and 148.5, respectively.

It’s also possible that the follow-up wasn’t long enough. The event rate was lower than expected at 5 years, but the values appeared to diverge at about 4 years, suggesting that further follow-up is justified to test whether early intensive multifactorial treatment reduces cardiovascular risk in the long term, the investigators concluded.

The trial was given unrestricted grants from Novo Nordisk AS, Novo Nordisk Scandinavia AB, Novo Nordisk UK, ASTRA Denmark, Pfizer Denmark, GlaxoSmithKline Pharma Denmark, Servier Denmark, and HemoCue Denmark.

SAN DIEGO – Early, multifactorial intervention in patients who were diagnosed with type 2 diabetes through screening reduced the incidence of cardiovascular events and death, albeit nonsignificantly, in a large, randomized controlled trial.

At the time of diagnosis, many patients with type 2 diabetes already have evidence of diabetic complications and potentially modifiable cardiovascular risk factors. Modeling studies have indicated that routine diabetes screening might be an efficient use of resources, but there has been no previous evidence from trials showing whether early intensive multifactorial treatment improves outcomes following detection by screening, said Dr. Simon J. Griffin, of the MRC Epidemiology Unit, Institute of Metabolic Science, Cambridge, England, and his associates.

Results of the Anglo-Danish-Dutch Study of Intensive Treatment in People With Screen Detected Diabetes in Primary Care (ADDITION-Europe) were presented by Dr. Griffen at the annual scientific sessions of the American Diabetes Association and simultaneously published online June 25 in the Lancet (2011 June 25 [doi:10.1016/S0140-6736(11)60698-3]).

The study used a cluster design, in which 343 general practices were randomized from April 2001 to December 2006 to routine diabetes care or intensive multifactorial treatment. A total of 157 of the practices randomized to routine care and 161 to intensive care completed screening and included eligible patients. Screening involved either calculation of a risk score followed by capillary glucose testing, or an oral glucose tolerance test.

The intensive-treatment intervention involved the stepwise addition of medications and promotion of healthy lifestyles aimed at achieving target-driven and guideline-driven management of hyperglycemia, blood pressure, and cholesterol levels. The same approach was used across all centers, although final decisions about prescriptions, including choice of individual drugs, were made by physicians and patients, Dr. Griffen and his associates said.

In all, 3,057 screen-identified patients aged 40-69 years were included. The mean follow-up period was 5.3 years, during which 238 first cardiovascular events occurred. The primary end point, a composite of cardiovascular events, occurred in 8.5% of the routine-care patients and 7.2% of the intervention group. The difference was statistically nonsignificant, with a hazard ratio (HR) of 0.83.

Trends were in favor of the multifactorial intervention for the composite components cardiovascular death, myocardial infarction, stroke, revascularization, and total mortality, but none of these achieved statistical significance. Differences were greatest for myocardial infarction (2.3% vs. 1.7%; HR, 0.7) and smallest for stroke (1.4% vs. 1.3%; HR, 0.98). Another component, amputation, did not occur as a first event in either group.

In both groups, more patients had values below target thresholds for hemoglobin A_1c concentrations, blood pressure, and cholesterol concentrations at follow-up than at baseline, but the proportion of patients meeting the targets was higher in the intensive-treatment group than in the routine-care group. The proportions of patients reporting hypoglycemia did not differ, the investigators said.

One possible explanation for the lack of a stronger effect is that the trial took place at a time of improved diabetes care delivery in general practice, which might have minimized the differences between the groups. At follow-up, mean HbA_1c values were 6.7% for routine care and 6.6% for intensive treatment, down from 7.0% in both groups at baseline. Systolic blood pressure was 138.1 mm Hg with routine care and 134.8 mm Hg with intensive intervention, down from 149.8 and 148.5, respectively.

It’s also possible that the follow-up wasn’t long enough. The event rate was lower than expected at 5 years, but the values appeared to diverge at about 4 years, suggesting that further follow-up is justified to test whether early intensive multifactorial treatment reduces cardiovascular risk in the long term, the investigators concluded.

The trial was given unrestricted grants from Novo Nordisk AS, Novo Nordisk Scandinavia AB, Novo Nordisk UK, ASTRA Denmark, Pfizer Denmark, GlaxoSmithKline Pharma Denmark, Servier Denmark, and HemoCue Denmark.

SAN DIEGO – An intensive diet intervention soon after diagnosis improved glycemic control, but the addition of physical activity provided no additional benefit in a randomized, controlled trial of 593 adults with recently diagnosed type 2 diabetes.

"These findings suggest that intervention at this early stage should focus on improving diet, since the additional cost of training health care workers to promote activity might not be justified," Dr. Robert C. Andrews of the University of Bristol (England) and his associates said.

©Michael Krinke/iStockphoto.com

Previous meta-analyses of exercise and diet studies have demonstrated significant reductions in hemoglobin A_1c levels (HbA_1c) of 0.5 to 0.8 percentage points with aerobic and resistance exercise and by dietary intervention. However, most of the studies included were of short duration, involved small numbers of patients, and rarely included newly diagnosed type 2 diabetes patients, the investigators said.

The Early Activity in Diabetes (Early ACTID) trial randomized patients, aged 30-80 years, who had been diagnosed with type 2 diabetes in the prior 5-8 months to one of three groups: A control group of 99 patients who received usual care, including standard dietary and exercise advice after randomization and at the end of the study; an intervention group of 248 patients who received only an intensive dietary intervention aimed at achieving a 5%-10% body weight loss; another intervention group of 246 patients who received the same dietary intervention, along with a physical activity intervention.

Patients in both intervention groups saw dieticians at baseline (for 1 hour) and at 3, 6, and 9 months (for 30 minutes), along with reinforcement by nurses during 15-minute visits about once every 6 weeks. Patients in the intensive diet and physical activity group received the same dietary intervention as did those in the intensive diet group. Additionally, they were asked to do at least 30 minutes of brisk walking at least 5 days per week. Activity targets were gradually increased over 5 weeks and then were maintained for the rest of the study.

At baseline, glycemic control was good in most patients across all groups, with 68% having HbA_1c below 7%, which is within the expected range in newly diagnosed patients, Dr. Andrews and his associates noted (Lancet 2011 [doi:10.1016/S0140-6736(11)60442-X]).

The primary end point was improvement in HbA_1c and blood pressure at 6 months.

The intention-to-treat comparison showed no differences between the intensive diet intervention and the intensive diet intervention plus activity for any primary outcomes. Mean HbA_1c concentrations were significantly lower at 6 and 12 months in patients who received either study intervention than in those who received usual care. At 12 months, HbA_1c values were 6.8% for the usual care group, 6.6% for diet alone group, and 6.7% for the diet and activity group. Systolic blood pressures were nearly identical for the three groups, 133 mm Hg, 132 mm Hg, and 133 mm Hg, respectively, with no significant differences from baseline in any of the groups.

Both intervention groups had significantly greater improvements than did the control group on secondary end points such as weight, reduction in waist and hip circumference, bioimpedance, and insulin resistance. However, the difference between the intervention groups was not significant.

Improvements were also seen in both study intervention groups at 6 months in concentrations of HDL cholesterol and triglycerides, more so in the intensive diet and activity group than in the intensive diet alone group, although these values were similar between the groups at 12 months.

Use of diabetes medications did not differ between the three groups at 6 months, but participants in the usual care group were more likely to be taking a diabetes medication at 12 months. Use of antihypertensive or antihyperlipidemic drugs did not differ at 6 or 12 months among the three groups.

The intensive diet intervention plus activity seemed to yield better results for HbA_1c concentration, body mass index, and insulin resistance in patients who had high baseline values than for those with low baseline values. For systolic blood pressure and, to a lesser degree, diastolic blood pressure, the diet and exercise intervention became less effective with increasing age at baseline, they said.

The exercise intervention may not have been effective because the activity undertaken might have been of insufficient intensity or been the incorrect type. The timing of the intervention may have been too early in the disease process to show additional response, as suggested by the fact that the diet plus exercise intervention worked best in patients who had high baseline HbA_1c concentrations, insulin resistance, and BMI values.

The attempt to modify two behaviors simultaneously might have diluted the effect of both. "Qualitative interview results suggest that people use a trade-off system in which they reward themselves for additional exercise with increased food intake," Dr. Andrews and his associates commented.

"I found it a little surprising that there was no additional benefit of exercise, but perhaps it’s true that people didn’t adhere as well to the diet, or perhaps the diet is just so powerful in the beginning that exercise doesn’t add that much," observed Dr. Sue Kirkman, senior vice president of medical affairs and community information for the ADA.

Dr. Andrews added, "We’re not saying exercise isn’t useful. We’re saying exercise didn’t improve the parameters that we measured. There’s a lot of clear evidence that individuals who exercise have a reduced cancer rate, reduced mortality, and get other benefits from exercising like well-being. ... In this context if we want to get HbA_1c better the first thing to do is concentrate on diet. We’re not saying don’t do exercise," he said in an interview.

"The Early ACTID trial shows clearly that intensive dietary support soon after the diagnosis of type 2 diabetes is beneficial. ... Our findings support the redesign of diabetes services to increase dietary management at an early stage. Because the intensive diet intervention was designed to be delivered by practice nurses with dietitian support, this approach could be translated into community-based services," they concluded.

The study was funded by Diabetes UK and the UK Department of Health. Two of the researchers reported financial relationships with companies including Bristol-Myers Squibb, GlaxoSmithKline, Medtronic, Novartis, Novo Nordisk, Sanofi-Aventis, and Eli Lilly.

SAN DIEGO – An intensive diet intervention soon after diagnosis improved glycemic control, but the addition of physical activity provided no additional benefit in a randomized, controlled trial of 593 adults with recently diagnosed type 2 diabetes.

"These findings suggest that intervention at this early stage should focus on improving diet, since the additional cost of training health care workers to promote activity might not be justified," Dr. Robert C. Andrews of the University of Bristol (England) and his associates said.

©Michael Krinke/iStockphoto.com

Previous meta-analyses of exercise and diet studies have demonstrated significant reductions in hemoglobin A_1c levels (HbA_1c) of 0.5 to 0.8 percentage points with aerobic and resistance exercise and by dietary intervention. However, most of the studies included were of short duration, involved small numbers of patients, and rarely included newly diagnosed type 2 diabetes patients, the investigators said.

The Early Activity in Diabetes (Early ACTID) trial randomized patients, aged 30-80 years, who had been diagnosed with type 2 diabetes in the prior 5-8 months to one of three groups: A control group of 99 patients who received usual care, including standard dietary and exercise advice after randomization and at the end of the study; an intervention group of 248 patients who received only an intensive dietary intervention aimed at achieving a 5%-10% body weight loss; another intervention group of 246 patients who received the same dietary intervention, along with a physical activity intervention.

Patients in both intervention groups saw dieticians at baseline (for 1 hour) and at 3, 6, and 9 months (for 30 minutes), along with reinforcement by nurses during 15-minute visits about once every 6 weeks. Patients in the intensive diet and physical activity group received the same dietary intervention as did those in the intensive diet group. Additionally, they were asked to do at least 30 minutes of brisk walking at least 5 days per week. Activity targets were gradually increased over 5 weeks and then were maintained for the rest of the study.

At baseline, glycemic control was good in most patients across all groups, with 68% having HbA_1c below 7%, which is within the expected range in newly diagnosed patients, Dr. Andrews and his associates noted (Lancet 2011 [doi:10.1016/S0140-6736(11)60442-X]).

The primary end point was improvement in HbA_1c and blood pressure at 6 months.

The intention-to-treat comparison showed no differences between the intensive diet intervention and the intensive diet intervention plus activity for any primary outcomes. Mean HbA_1c concentrations were significantly lower at 6 and 12 months in patients who received either study intervention than in those who received usual care. At 12 months, HbA_1c values were 6.8% for the usual care group, 6.6% for diet alone group, and 6.7% for the diet and activity group. Systolic blood pressures were nearly identical for the three groups, 133 mm Hg, 132 mm Hg, and 133 mm Hg, respectively, with no significant differences from baseline in any of the groups.

Both intervention groups had significantly greater improvements than did the control group on secondary end points such as weight, reduction in waist and hip circumference, bioimpedance, and insulin resistance. However, the difference between the intervention groups was not significant.

Improvements were also seen in both study intervention groups at 6 months in concentrations of HDL cholesterol and triglycerides, more so in the intensive diet and activity group than in the intensive diet alone group, although these values were similar between the groups at 12 months.

Use of diabetes medications did not differ between the three groups at 6 months, but participants in the usual care group were more likely to be taking a diabetes medication at 12 months. Use of antihypertensive or antihyperlipidemic drugs did not differ at 6 or 12 months among the three groups.

The intensive diet intervention plus activity seemed to yield better results for HbA_1c concentration, body mass index, and insulin resistance in patients who had high baseline values than for those with low baseline values. For systolic blood pressure and, to a lesser degree, diastolic blood pressure, the diet and exercise intervention became less effective with increasing age at baseline, they said.

The exercise intervention may not have been effective because the activity undertaken might have been of insufficient intensity or been the incorrect type. The timing of the intervention may have been too early in the disease process to show additional response, as suggested by the fact that the diet plus exercise intervention worked best in patients who had high baseline HbA_1c concentrations, insulin resistance, and BMI values.

The attempt to modify two behaviors simultaneously might have diluted the effect of both. "Qualitative interview results suggest that people use a trade-off system in which they reward themselves for additional exercise with increased food intake," Dr. Andrews and his associates commented.

"I found it a little surprising that there was no additional benefit of exercise, but perhaps it’s true that people didn’t adhere as well to the diet, or perhaps the diet is just so powerful in the beginning that exercise doesn’t add that much," observed Dr. Sue Kirkman, senior vice president of medical affairs and community information for the ADA.

Dr. Andrews added, "We’re not saying exercise isn’t useful. We’re saying exercise didn’t improve the parameters that we measured. There’s a lot of clear evidence that individuals who exercise have a reduced cancer rate, reduced mortality, and get other benefits from exercising like well-being. ... In this context if we want to get HbA_1c better the first thing to do is concentrate on diet. We’re not saying don’t do exercise," he said in an interview.

"The Early ACTID trial shows clearly that intensive dietary support soon after the diagnosis of type 2 diabetes is beneficial. ... Our findings support the redesign of diabetes services to increase dietary management at an early stage. Because the intensive diet intervention was designed to be delivered by practice nurses with dietitian support, this approach could be translated into community-based services," they concluded.

The study was funded by Diabetes UK and the UK Department of Health. Two of the researchers reported financial relationships with companies including Bristol-Myers Squibb, GlaxoSmithKline, Medtronic, Novartis, Novo Nordisk, Sanofi-Aventis, and Eli Lilly.

SAN DIEGO – An intensive diet intervention soon after diagnosis improved glycemic control, but the addition of physical activity provided no additional benefit in a randomized, controlled trial of 593 adults with recently diagnosed type 2 diabetes.

"These findings suggest that intervention at this early stage should focus on improving diet, since the additional cost of training health care workers to promote activity might not be justified," Dr. Robert C. Andrews of the University of Bristol (England) and his associates said.

©Michael Krinke/iStockphoto.com

Previous meta-analyses of exercise and diet studies have demonstrated significant reductions in hemoglobin A_1c levels (HbA_1c) of 0.5 to 0.8 percentage points with aerobic and resistance exercise and by dietary intervention. However, most of the studies included were of short duration, involved small numbers of patients, and rarely included newly diagnosed type 2 diabetes patients, the investigators said.

The Early Activity in Diabetes (Early ACTID) trial randomized patients, aged 30-80 years, who had been diagnosed with type 2 diabetes in the prior 5-8 months to one of three groups: A control group of 99 patients who received usual care, including standard dietary and exercise advice after randomization and at the end of the study; an intervention group of 248 patients who received only an intensive dietary intervention aimed at achieving a 5%-10% body weight loss; another intervention group of 246 patients who received the same dietary intervention, along with a physical activity intervention.

Patients in both intervention groups saw dieticians at baseline (for 1 hour) and at 3, 6, and 9 months (for 30 minutes), along with reinforcement by nurses during 15-minute visits about once every 6 weeks. Patients in the intensive diet and physical activity group received the same dietary intervention as did those in the intensive diet group. Additionally, they were asked to do at least 30 minutes of brisk walking at least 5 days per week. Activity targets were gradually increased over 5 weeks and then were maintained for the rest of the study.

At baseline, glycemic control was good in most patients across all groups, with 68% having HbA_1c below 7%, which is within the expected range in newly diagnosed patients, Dr. Andrews and his associates noted (Lancet 2011 [doi:10.1016/S0140-6736(11)60442-X]).

The primary end point was improvement in HbA_1c and blood pressure at 6 months.

The intention-to-treat comparison showed no differences between the intensive diet intervention and the intensive diet intervention plus activity for any primary outcomes. Mean HbA_1c concentrations were significantly lower at 6 and 12 months in patients who received either study intervention than in those who received usual care. At 12 months, HbA_1c values were 6.8% for the usual care group, 6.6% for diet alone group, and 6.7% for the diet and activity group. Systolic blood pressures were nearly identical for the three groups, 133 mm Hg, 132 mm Hg, and 133 mm Hg, respectively, with no significant differences from baseline in any of the groups.

Both intervention groups had significantly greater improvements than did the control group on secondary end points such as weight, reduction in waist and hip circumference, bioimpedance, and insulin resistance. However, the difference between the intervention groups was not significant.

Improvements were also seen in both study intervention groups at 6 months in concentrations of HDL cholesterol and triglycerides, more so in the intensive diet and activity group than in the intensive diet alone group, although these values were similar between the groups at 12 months.

Use of diabetes medications did not differ between the three groups at 6 months, but participants in the usual care group were more likely to be taking a diabetes medication at 12 months. Use of antihypertensive or antihyperlipidemic drugs did not differ at 6 or 12 months among the three groups.

The intensive diet intervention plus activity seemed to yield better results for HbA_1c concentration, body mass index, and insulin resistance in patients who had high baseline values than for those with low baseline values. For systolic blood pressure and, to a lesser degree, diastolic blood pressure, the diet and exercise intervention became less effective with increasing age at baseline, they said.

The exercise intervention may not have been effective because the activity undertaken might have been of insufficient intensity or been the incorrect type. The timing of the intervention may have been too early in the disease process to show additional response, as suggested by the fact that the diet plus exercise intervention worked best in patients who had high baseline HbA_1c concentrations, insulin resistance, and BMI values.

The attempt to modify two behaviors simultaneously might have diluted the effect of both. "Qualitative interview results suggest that people use a trade-off system in which they reward themselves for additional exercise with increased food intake," Dr. Andrews and his associates commented.

"I found it a little surprising that there was no additional benefit of exercise, but perhaps it’s true that people didn’t adhere as well to the diet, or perhaps the diet is just so powerful in the beginning that exercise doesn’t add that much," observed Dr. Sue Kirkman, senior vice president of medical affairs and community information for the ADA.

Dr. Andrews added, "We’re not saying exercise isn’t useful. We’re saying exercise didn’t improve the parameters that we measured. There’s a lot of clear evidence that individuals who exercise have a reduced cancer rate, reduced mortality, and get other benefits from exercising like well-being. ... In this context if we want to get HbA_1c better the first thing to do is concentrate on diet. We’re not saying don’t do exercise," he said in an interview.

"The Early ACTID trial shows clearly that intensive dietary support soon after the diagnosis of type 2 diabetes is beneficial. ... Our findings support the redesign of diabetes services to increase dietary management at an early stage. Because the intensive diet intervention was designed to be delivered by practice nurses with dietitian support, this approach could be translated into community-based services," they concluded.

The study was funded by Diabetes UK and the UK Department of Health. Two of the researchers reported financial relationships with companies including Bristol-Myers Squibb, GlaxoSmithKline, Medtronic, Novartis, Novo Nordisk, Sanofi-Aventis, and Eli Lilly.