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Prediabetes Interventions Shown Cost Effective
SAN DIEGO – Few medical interventions both improve health and save money. Treating prediabetes with metformin is one of them, according to 10-year follow-up data from the Diabetes Prevention Program.
Intensive lifestyle intervention, the other treatment arm in the randomized, placebo-controlled Diabetes Prevention Program (DPP) study, did an even better job at improving health and quality of life, and at a favorable cost when compared with some common medical interventions for other diagnoses, Dr. William H. Herman and his associates reported at the annual scientific sessions of the American Diabetes Association.
Most of the costs for the placebo group in the ensuing decade were related to conversion of subjects’ prediabetes to diabetes, explained Dr. Herman, professor of medicine and epidemiology at the University of Michigan, Ann Arbor.
At baseline, all 3,234 participants in the DPP were nondiabetic, were overweight or obese, and had impaired glucose tolerance and an elevated fasting glucose level.
Metformin treatment (850 mg b.i.d.) reduced overall costs for medical care in those 10 years by $1,700 per person, and lifestyle intervention reduced those costs by $2,600 per person. After factoring in the costs of the interventions, the researchers found that metformin treatment produced a savings of $30 per patient compared with placebo over the 10 years.
The cost-saving benefits of metformin for people at high risk of diabetes puts this preventive intervention in a league with prenatal care, pediatric immunizations, and influenza vaccinations for people older than 65 years, Dr. Herman said. Only 1 in 10 medical interventions are cost-saving, he noted.
With the lifestyle intervention, overall costs were $1,500 per person greater than placebo, a price tag that puts lifestyle intervention for prediabetes in a league with some of the most widely accepted medical interventions when converted for comparison into quality-adjusted life-years gained.
In simple terms, the cost for a quality-adjusted life-year gained is the price "to buy 1 year of life in essentially perfect health," he explained.
In this study, the cost per quality-adjusted life-year gained with the intensive lifestyle intervention compared with the placebo group was $12,000. That $12,000 is on the low end of a $10,000-$50,000 range that’s widely accepted for medical interventions, including the use of beta-blockers after MI, the use of antihypertensive therapy for patients with very high diastolic blood pressure (greater than 105 mm Hg), or the use of statins for secondary prevention of cardiovascular disease in patients who’ve had an MI. Dialysis for end-stage renal disease costs $50,000-$100,000 per quality-adjusted life-year gained.
When the DPP results first came out, "The reaction in the medical community was, ‘This is great, but we don’t have the resources to implement it,’ " Dr. Herman said. Controversy continued due to conflicting results from analyses that modeled cost effectiveness over time based on the 3-year results of the DPP. The current study used real-life cost data collected prospectively for the study period and the following 7 years.
The results show that for patients with prediabetes, "metformin is cost saving. Intensive lifestyle intervention, though not cost saving, is extremely cost effective," Dr. Herman said. "It represents good value for the money."
The DPP’s lifestyle intervention aimed for a 7% reduction in body weight and 150 minutes per week of moderately intense physical activity, usually 30 minutes per day of brisk walking 5 days per week. Patients were asked to attend 16 sessions in a 6-month period for nutritional and exercise guidance and received ongoing follow-up with a case manager. After 3 years, the incidence of diabetes was 58% lower in the lifestyle intervention group and 31% lower with metformin compared with the placebo group (N. Engl. J. Med. 2002;346:393-403). The diabetes incidence was 5 cases per 100 person-years in the lifestyle group compared with 8 in the metformin group, and 11 in the placebo group.
During the next 7 years, patients in the metformin group were encouraged to continue the medication, and those in the lifestyle intervention group were offered a less intensive lifestyle intervention with fewer individual sessions. At the 10-year mark, the risk for developing diabetes was 34% less in the lifestyle intervention group and 18% less in the metformin group compared with the control group, Dr. Herman said. Quality of life was rated significantly higher in the metformin group compared with the placebo group, and significantly higher in the lifestyle intervention group compared with the metformin or placebo groups.
Implementation of a lifestyle intervention should be as simple as writing a prescription for a pill to prevent diabetes, Dr. Herman suggested. One way to build access to lifestyle interventions might be to locate them in cardiac rehabilitation centers, which already contain the facilities needed for exercise and other components of the intervention.
"Translating these findings into practice will reduce the development of type 2 diabetes, which has become one of the most common and costly diseases," Dr. Griffin P. Rodgers said in a statement released by the American Diabetes Association. Dr. Rodgers is director of the National Institute of Diabetes and Digestive and Kidney Diseases.
The costs of lifestyle intervention to prevent diabetes will decline over time, Dr. Herman said. The data suggest that the DPP’s intensive lifestyle intervention can be adapted into a less-expensive, but still effective, group-based model without having to reinvent everything, he added. Instead of 16 sessions in 6 months, patients may have a yearly session with a dietician.
Dr. Herman has been a consultant for McKinsey & Company.
As a practicing primary care physician and a type 2 diabetes researcher, I’m really stunned by these findings. I think they are going to cause a lot of discussion in prevention and policy circles.
There are very few interventions that come along especially pharmaceutical interventions that save money. Metformin is very cheap and it has modest side effects. This could revolutionize the way we approach the management of diabetes prevention.
Many patients prefer lifestyle changes at first as opposed to taking a pill, especially when they consider themselves healthy. The costs of these kinds of efforts already are covered in some ways by some health insurance plans that cover health club memberships.
Getting health insurers to adopt this kind of prevention attitude is a harder sell. Certainly, this kind of evidence has the capacity to shift the way we think about prevention.
The issue for me in trying to incorporate these findings into my practice will be in deciding which patients qualify for the interventions. Some of the eligibility tests performed in the Diabetes Prevention Program are not readily done in the primary care setting. Approximately half of the people in the study had metabolic syndrome, so that might be one way of deciding which individuals to focus on when considering these preventive interventions.
James B. Meigs, M.D., is an associate professor of medicine at Harvard Medical School and Massachusetts General Hospital, Boston. He reported having no relevant conflicts of interest.
lifestyle intervention, Dr. William H. Herman, the American Diabetes Association,
As a practicing primary care physician and a type 2 diabetes researcher, I’m really stunned by these findings. I think they are going to cause a lot of discussion in prevention and policy circles.
There are very few interventions that come along especially pharmaceutical interventions that save money. Metformin is very cheap and it has modest side effects. This could revolutionize the way we approach the management of diabetes prevention.
Many patients prefer lifestyle changes at first as opposed to taking a pill, especially when they consider themselves healthy. The costs of these kinds of efforts already are covered in some ways by some health insurance plans that cover health club memberships.
Getting health insurers to adopt this kind of prevention attitude is a harder sell. Certainly, this kind of evidence has the capacity to shift the way we think about prevention.
The issue for me in trying to incorporate these findings into my practice will be in deciding which patients qualify for the interventions. Some of the eligibility tests performed in the Diabetes Prevention Program are not readily done in the primary care setting. Approximately half of the people in the study had metabolic syndrome, so that might be one way of deciding which individuals to focus on when considering these preventive interventions.
James B. Meigs, M.D., is an associate professor of medicine at Harvard Medical School and Massachusetts General Hospital, Boston. He reported having no relevant conflicts of interest.
As a practicing primary care physician and a type 2 diabetes researcher, I’m really stunned by these findings. I think they are going to cause a lot of discussion in prevention and policy circles.
There are very few interventions that come along especially pharmaceutical interventions that save money. Metformin is very cheap and it has modest side effects. This could revolutionize the way we approach the management of diabetes prevention.
Many patients prefer lifestyle changes at first as opposed to taking a pill, especially when they consider themselves healthy. The costs of these kinds of efforts already are covered in some ways by some health insurance plans that cover health club memberships.
Getting health insurers to adopt this kind of prevention attitude is a harder sell. Certainly, this kind of evidence has the capacity to shift the way we think about prevention.
The issue for me in trying to incorporate these findings into my practice will be in deciding which patients qualify for the interventions. Some of the eligibility tests performed in the Diabetes Prevention Program are not readily done in the primary care setting. Approximately half of the people in the study had metabolic syndrome, so that might be one way of deciding which individuals to focus on when considering these preventive interventions.
James B. Meigs, M.D., is an associate professor of medicine at Harvard Medical School and Massachusetts General Hospital, Boston. He reported having no relevant conflicts of interest.
SAN DIEGO – Few medical interventions both improve health and save money. Treating prediabetes with metformin is one of them, according to 10-year follow-up data from the Diabetes Prevention Program.
Intensive lifestyle intervention, the other treatment arm in the randomized, placebo-controlled Diabetes Prevention Program (DPP) study, did an even better job at improving health and quality of life, and at a favorable cost when compared with some common medical interventions for other diagnoses, Dr. William H. Herman and his associates reported at the annual scientific sessions of the American Diabetes Association.
Most of the costs for the placebo group in the ensuing decade were related to conversion of subjects’ prediabetes to diabetes, explained Dr. Herman, professor of medicine and epidemiology at the University of Michigan, Ann Arbor.
At baseline, all 3,234 participants in the DPP were nondiabetic, were overweight or obese, and had impaired glucose tolerance and an elevated fasting glucose level.
Metformin treatment (850 mg b.i.d.) reduced overall costs for medical care in those 10 years by $1,700 per person, and lifestyle intervention reduced those costs by $2,600 per person. After factoring in the costs of the interventions, the researchers found that metformin treatment produced a savings of $30 per patient compared with placebo over the 10 years.
The cost-saving benefits of metformin for people at high risk of diabetes puts this preventive intervention in a league with prenatal care, pediatric immunizations, and influenza vaccinations for people older than 65 years, Dr. Herman said. Only 1 in 10 medical interventions are cost-saving, he noted.
With the lifestyle intervention, overall costs were $1,500 per person greater than placebo, a price tag that puts lifestyle intervention for prediabetes in a league with some of the most widely accepted medical interventions when converted for comparison into quality-adjusted life-years gained.
In simple terms, the cost for a quality-adjusted life-year gained is the price "to buy 1 year of life in essentially perfect health," he explained.
In this study, the cost per quality-adjusted life-year gained with the intensive lifestyle intervention compared with the placebo group was $12,000. That $12,000 is on the low end of a $10,000-$50,000 range that’s widely accepted for medical interventions, including the use of beta-blockers after MI, the use of antihypertensive therapy for patients with very high diastolic blood pressure (greater than 105 mm Hg), or the use of statins for secondary prevention of cardiovascular disease in patients who’ve had an MI. Dialysis for end-stage renal disease costs $50,000-$100,000 per quality-adjusted life-year gained.
When the DPP results first came out, "The reaction in the medical community was, ‘This is great, but we don’t have the resources to implement it,’ " Dr. Herman said. Controversy continued due to conflicting results from analyses that modeled cost effectiveness over time based on the 3-year results of the DPP. The current study used real-life cost data collected prospectively for the study period and the following 7 years.
The results show that for patients with prediabetes, "metformin is cost saving. Intensive lifestyle intervention, though not cost saving, is extremely cost effective," Dr. Herman said. "It represents good value for the money."
The DPP’s lifestyle intervention aimed for a 7% reduction in body weight and 150 minutes per week of moderately intense physical activity, usually 30 minutes per day of brisk walking 5 days per week. Patients were asked to attend 16 sessions in a 6-month period for nutritional and exercise guidance and received ongoing follow-up with a case manager. After 3 years, the incidence of diabetes was 58% lower in the lifestyle intervention group and 31% lower with metformin compared with the placebo group (N. Engl. J. Med. 2002;346:393-403). The diabetes incidence was 5 cases per 100 person-years in the lifestyle group compared with 8 in the metformin group, and 11 in the placebo group.
During the next 7 years, patients in the metformin group were encouraged to continue the medication, and those in the lifestyle intervention group were offered a less intensive lifestyle intervention with fewer individual sessions. At the 10-year mark, the risk for developing diabetes was 34% less in the lifestyle intervention group and 18% less in the metformin group compared with the control group, Dr. Herman said. Quality of life was rated significantly higher in the metformin group compared with the placebo group, and significantly higher in the lifestyle intervention group compared with the metformin or placebo groups.
Implementation of a lifestyle intervention should be as simple as writing a prescription for a pill to prevent diabetes, Dr. Herman suggested. One way to build access to lifestyle interventions might be to locate them in cardiac rehabilitation centers, which already contain the facilities needed for exercise and other components of the intervention.
"Translating these findings into practice will reduce the development of type 2 diabetes, which has become one of the most common and costly diseases," Dr. Griffin P. Rodgers said in a statement released by the American Diabetes Association. Dr. Rodgers is director of the National Institute of Diabetes and Digestive and Kidney Diseases.
The costs of lifestyle intervention to prevent diabetes will decline over time, Dr. Herman said. The data suggest that the DPP’s intensive lifestyle intervention can be adapted into a less-expensive, but still effective, group-based model without having to reinvent everything, he added. Instead of 16 sessions in 6 months, patients may have a yearly session with a dietician.
Dr. Herman has been a consultant for McKinsey & Company.
SAN DIEGO – Few medical interventions both improve health and save money. Treating prediabetes with metformin is one of them, according to 10-year follow-up data from the Diabetes Prevention Program.
Intensive lifestyle intervention, the other treatment arm in the randomized, placebo-controlled Diabetes Prevention Program (DPP) study, did an even better job at improving health and quality of life, and at a favorable cost when compared with some common medical interventions for other diagnoses, Dr. William H. Herman and his associates reported at the annual scientific sessions of the American Diabetes Association.
Most of the costs for the placebo group in the ensuing decade were related to conversion of subjects’ prediabetes to diabetes, explained Dr. Herman, professor of medicine and epidemiology at the University of Michigan, Ann Arbor.
At baseline, all 3,234 participants in the DPP were nondiabetic, were overweight or obese, and had impaired glucose tolerance and an elevated fasting glucose level.
Metformin treatment (850 mg b.i.d.) reduced overall costs for medical care in those 10 years by $1,700 per person, and lifestyle intervention reduced those costs by $2,600 per person. After factoring in the costs of the interventions, the researchers found that metformin treatment produced a savings of $30 per patient compared with placebo over the 10 years.
The cost-saving benefits of metformin for people at high risk of diabetes puts this preventive intervention in a league with prenatal care, pediatric immunizations, and influenza vaccinations for people older than 65 years, Dr. Herman said. Only 1 in 10 medical interventions are cost-saving, he noted.
With the lifestyle intervention, overall costs were $1,500 per person greater than placebo, a price tag that puts lifestyle intervention for prediabetes in a league with some of the most widely accepted medical interventions when converted for comparison into quality-adjusted life-years gained.
In simple terms, the cost for a quality-adjusted life-year gained is the price "to buy 1 year of life in essentially perfect health," he explained.
In this study, the cost per quality-adjusted life-year gained with the intensive lifestyle intervention compared with the placebo group was $12,000. That $12,000 is on the low end of a $10,000-$50,000 range that’s widely accepted for medical interventions, including the use of beta-blockers after MI, the use of antihypertensive therapy for patients with very high diastolic blood pressure (greater than 105 mm Hg), or the use of statins for secondary prevention of cardiovascular disease in patients who’ve had an MI. Dialysis for end-stage renal disease costs $50,000-$100,000 per quality-adjusted life-year gained.
When the DPP results first came out, "The reaction in the medical community was, ‘This is great, but we don’t have the resources to implement it,’ " Dr. Herman said. Controversy continued due to conflicting results from analyses that modeled cost effectiveness over time based on the 3-year results of the DPP. The current study used real-life cost data collected prospectively for the study period and the following 7 years.
The results show that for patients with prediabetes, "metformin is cost saving. Intensive lifestyle intervention, though not cost saving, is extremely cost effective," Dr. Herman said. "It represents good value for the money."
The DPP’s lifestyle intervention aimed for a 7% reduction in body weight and 150 minutes per week of moderately intense physical activity, usually 30 minutes per day of brisk walking 5 days per week. Patients were asked to attend 16 sessions in a 6-month period for nutritional and exercise guidance and received ongoing follow-up with a case manager. After 3 years, the incidence of diabetes was 58% lower in the lifestyle intervention group and 31% lower with metformin compared with the placebo group (N. Engl. J. Med. 2002;346:393-403). The diabetes incidence was 5 cases per 100 person-years in the lifestyle group compared with 8 in the metformin group, and 11 in the placebo group.
During the next 7 years, patients in the metformin group were encouraged to continue the medication, and those in the lifestyle intervention group were offered a less intensive lifestyle intervention with fewer individual sessions. At the 10-year mark, the risk for developing diabetes was 34% less in the lifestyle intervention group and 18% less in the metformin group compared with the control group, Dr. Herman said. Quality of life was rated significantly higher in the metformin group compared with the placebo group, and significantly higher in the lifestyle intervention group compared with the metformin or placebo groups.
Implementation of a lifestyle intervention should be as simple as writing a prescription for a pill to prevent diabetes, Dr. Herman suggested. One way to build access to lifestyle interventions might be to locate them in cardiac rehabilitation centers, which already contain the facilities needed for exercise and other components of the intervention.
"Translating these findings into practice will reduce the development of type 2 diabetes, which has become one of the most common and costly diseases," Dr. Griffin P. Rodgers said in a statement released by the American Diabetes Association. Dr. Rodgers is director of the National Institute of Diabetes and Digestive and Kidney Diseases.
The costs of lifestyle intervention to prevent diabetes will decline over time, Dr. Herman said. The data suggest that the DPP’s intensive lifestyle intervention can be adapted into a less-expensive, but still effective, group-based model without having to reinvent everything, he added. Instead of 16 sessions in 6 months, patients may have a yearly session with a dietician.
Dr. Herman has been a consultant for McKinsey & Company.
lifestyle intervention, Dr. William H. Herman, the American Diabetes Association,
lifestyle intervention, Dr. William H. Herman, the American Diabetes Association,
FROM THE ANNUAL SCIENTIFIC SESSIONS OF THE AMERICAN DIABETES ASSOCIATION
Major Finding: Over a 10-year period, the incidence of diabetes among people who were prediabetic at baseline was 18% lower among those treated with metformin and 34% lower among those in a lifestyle intervention, compared with individuals in a placebo-controlled group. Use of metformin reduced overall medical costs by $30 per patient. The lifestyle intervention was deemed cost effective at $1,500 per quality-adjusted life-year gained compared with placebo.
Data Source: Analysis of data from the 3-year Diabetes Prevention Program, which involved 3,234 people with prediabetes, plus 7 years of prospective follow-up in which they were encouraged to continue the interventions.
Disclosures: Dr. Herman has been a consultant for McKinsey & Company.
Prediabetes Interventions Shown Cost Effective
SAN DIEGO – Few medical interventions both improve health and save money. Treating prediabetes with metformin is one of them, according to 10-year follow-up data from the Diabetes Prevention Program.
Intensive lifestyle intervention, the other treatment arm in the randomized, placebo-controlled Diabetes Prevention Program (DPP) study, did an even better job at improving health and quality of life, and at a favorable cost when compared with some common medical interventions for other diagnoses, Dr. William H. Herman and his associates reported at the annual scientific sessions of the American Diabetes Association.
Most of the costs for the placebo group in the ensuing decade were related to conversion of subjects’ prediabetes to diabetes, explained Dr. Herman, professor of medicine and epidemiology at the University of Michigan, Ann Arbor.
At baseline, all 3,234 participants in the DPP were nondiabetic, were overweight or obese, and had impaired glucose tolerance and an elevated fasting glucose level.
Metformin treatment (850 mg b.i.d.) reduced overall costs for medical care in those 10 years by $1,700 per person, and lifestyle intervention reduced those costs by $2,600 per person. After factoring in the costs of the interventions, the researchers found that metformin treatment produced a savings of $30 per patient compared with placebo over the 10 years.
The cost-saving benefits of metformin for people at high risk of diabetes puts this preventive intervention in a league with prenatal care, pediatric immunizations, and influenza vaccinations for people older than 65 years, Dr. Herman said. Only 1 in 10 medical interventions are cost-saving, he noted.
With the lifestyle intervention, overall costs were $1,500 per person greater than placebo, a price tag that puts lifestyle intervention for prediabetes in a league with some of the most widely accepted medical interventions when converted for comparison into quality-adjusted life-years gained.
In simple terms, the cost for a quality-adjusted life-year gained is the price "to buy 1 year of life in essentially perfect health," he explained.
In this study, the cost per quality-adjusted life-year gained with the intensive lifestyle intervention compared with the placebo group was $12,000. That $12,000 is on the low end of a $10,000-$50,000 range that’s widely accepted for medical interventions, including the use of beta-blockers after MI, the use of antihypertensive therapy for patients with very high diastolic blood pressure (greater than 105 mm Hg), or the use of statins for secondary prevention of cardiovascular disease in patients who’ve had an MI. Dialysis for end-stage renal disease costs $50,000-$100,000 per quality-adjusted life-year gained.
When the DPP results first came out, "The reaction in the medical community was, ‘This is great, but we don’t have the resources to implement it,’ " Dr. Herman said. Controversy continued due to conflicting results from analyses that modeled cost effectiveness over time based on the 3-year results of the DPP. The current study used real-life cost data collected prospectively for the study period and the following 7 years.
The results show that for patients with prediabetes, "metformin is cost saving. Intensive lifestyle intervention, though not cost saving, is extremely cost effective," Dr. Herman said. "It represents good value for the money."
The DPP’s lifestyle intervention aimed for a 7% reduction in body weight and 150 minutes per week of moderately intense physical activity, usually 30 minutes per day of brisk walking 5 days per week. Patients were asked to attend 16 sessions in a 6-month period for nutritional and exercise guidance and received ongoing follow-up with a case manager. After 3 years, the incidence of diabetes was 58% lower in the lifestyle intervention group and 31% lower with metformin compared with the placebo group (N. Engl. J. Med. 2002;346:393-403). The diabetes incidence was 5 cases per 100 person-years in the lifestyle group compared with 8 in the metformin group, and 11 in the placebo group.
During the next 7 years, patients in the metformin group were encouraged to continue the medication, and those in the lifestyle intervention group were offered a less intensive lifestyle intervention with fewer individual sessions. At the 10-year mark, the risk for developing diabetes was 34% less in the lifestyle intervention group and 18% less in the metformin group compared with the control group, Dr. Herman said. Quality of life was rated significantly higher in the metformin group compared with the placebo group, and significantly higher in the lifestyle intervention group compared with the metformin or placebo groups.
Implementation of a lifestyle intervention should be as simple as writing a prescription for a pill to prevent diabetes, Dr. Herman suggested. One way to build access to lifestyle interventions might be to locate them in cardiac rehabilitation centers, which already contain the facilities needed for exercise and other components of the intervention.
"Translating these findings into practice will reduce the development of type 2 diabetes, which has become one of the most common and costly diseases," Dr. Griffin P. Rodgers said in a statement released by the American Diabetes Association. Dr. Rodgers is director of the National Institute of Diabetes and Digestive and Kidney Diseases.
The costs of lifestyle intervention to prevent diabetes will decline over time, Dr. Herman said. The data suggest that the DPP’s intensive lifestyle intervention can be adapted into a less-expensive, but still effective, group-based model without having to reinvent everything, he added. Instead of 16 sessions in 6 months, patients may have a yearly session with a dietician.
Dr. Herman has been a consultant for McKinsey & Company.
As a practicing primary care physician and a type 2 diabetes researcher, I’m really stunned by these findings. I think they are going to cause a lot of discussion in prevention and policy circles.
There are very few interventions that come along especially pharmaceutical interventions that save money. Metformin is very cheap and it has modest side effects. This could revolutionize the way we approach the management of diabetes prevention.
Many patients prefer lifestyle changes at first as opposed to taking a pill, especially when they consider themselves healthy. The costs of these kinds of efforts already are covered in some ways by some health insurance plans that cover health club memberships.
Getting health insurers to adopt this kind of prevention attitude is a harder sell. Certainly, this kind of evidence has the capacity to shift the way we think about prevention.
The issue for me in trying to incorporate these findings into my practice will be in deciding which patients qualify for the interventions. Some of the eligibility tests performed in the Diabetes Prevention Program are not readily done in the primary care setting. Approximately half of the people in the study had metabolic syndrome, so that might be one way of deciding which individuals to focus on when considering these preventive interventions.
James B. Meigs, M.D., is an associate professor of medicine at Harvard Medical School and Massachusetts General Hospital, Boston. He reported having no relevant conflicts of interest.
lifestyle intervention, Dr. William H. Herman, the American Diabetes Association,
As a practicing primary care physician and a type 2 diabetes researcher, I’m really stunned by these findings. I think they are going to cause a lot of discussion in prevention and policy circles.
There are very few interventions that come along especially pharmaceutical interventions that save money. Metformin is very cheap and it has modest side effects. This could revolutionize the way we approach the management of diabetes prevention.
Many patients prefer lifestyle changes at first as opposed to taking a pill, especially when they consider themselves healthy. The costs of these kinds of efforts already are covered in some ways by some health insurance plans that cover health club memberships.
Getting health insurers to adopt this kind of prevention attitude is a harder sell. Certainly, this kind of evidence has the capacity to shift the way we think about prevention.
The issue for me in trying to incorporate these findings into my practice will be in deciding which patients qualify for the interventions. Some of the eligibility tests performed in the Diabetes Prevention Program are not readily done in the primary care setting. Approximately half of the people in the study had metabolic syndrome, so that might be one way of deciding which individuals to focus on when considering these preventive interventions.
James B. Meigs, M.D., is an associate professor of medicine at Harvard Medical School and Massachusetts General Hospital, Boston. He reported having no relevant conflicts of interest.
As a practicing primary care physician and a type 2 diabetes researcher, I’m really stunned by these findings. I think they are going to cause a lot of discussion in prevention and policy circles.
There are very few interventions that come along especially pharmaceutical interventions that save money. Metformin is very cheap and it has modest side effects. This could revolutionize the way we approach the management of diabetes prevention.
Many patients prefer lifestyle changes at first as opposed to taking a pill, especially when they consider themselves healthy. The costs of these kinds of efforts already are covered in some ways by some health insurance plans that cover health club memberships.
Getting health insurers to adopt this kind of prevention attitude is a harder sell. Certainly, this kind of evidence has the capacity to shift the way we think about prevention.
The issue for me in trying to incorporate these findings into my practice will be in deciding which patients qualify for the interventions. Some of the eligibility tests performed in the Diabetes Prevention Program are not readily done in the primary care setting. Approximately half of the people in the study had metabolic syndrome, so that might be one way of deciding which individuals to focus on when considering these preventive interventions.
James B. Meigs, M.D., is an associate professor of medicine at Harvard Medical School and Massachusetts General Hospital, Boston. He reported having no relevant conflicts of interest.
SAN DIEGO – Few medical interventions both improve health and save money. Treating prediabetes with metformin is one of them, according to 10-year follow-up data from the Diabetes Prevention Program.
Intensive lifestyle intervention, the other treatment arm in the randomized, placebo-controlled Diabetes Prevention Program (DPP) study, did an even better job at improving health and quality of life, and at a favorable cost when compared with some common medical interventions for other diagnoses, Dr. William H. Herman and his associates reported at the annual scientific sessions of the American Diabetes Association.
Most of the costs for the placebo group in the ensuing decade were related to conversion of subjects’ prediabetes to diabetes, explained Dr. Herman, professor of medicine and epidemiology at the University of Michigan, Ann Arbor.
At baseline, all 3,234 participants in the DPP were nondiabetic, were overweight or obese, and had impaired glucose tolerance and an elevated fasting glucose level.
Metformin treatment (850 mg b.i.d.) reduced overall costs for medical care in those 10 years by $1,700 per person, and lifestyle intervention reduced those costs by $2,600 per person. After factoring in the costs of the interventions, the researchers found that metformin treatment produced a savings of $30 per patient compared with placebo over the 10 years.
The cost-saving benefits of metformin for people at high risk of diabetes puts this preventive intervention in a league with prenatal care, pediatric immunizations, and influenza vaccinations for people older than 65 years, Dr. Herman said. Only 1 in 10 medical interventions are cost-saving, he noted.
With the lifestyle intervention, overall costs were $1,500 per person greater than placebo, a price tag that puts lifestyle intervention for prediabetes in a league with some of the most widely accepted medical interventions when converted for comparison into quality-adjusted life-years gained.
In simple terms, the cost for a quality-adjusted life-year gained is the price "to buy 1 year of life in essentially perfect health," he explained.
In this study, the cost per quality-adjusted life-year gained with the intensive lifestyle intervention compared with the placebo group was $12,000. That $12,000 is on the low end of a $10,000-$50,000 range that’s widely accepted for medical interventions, including the use of beta-blockers after MI, the use of antihypertensive therapy for patients with very high diastolic blood pressure (greater than 105 mm Hg), or the use of statins for secondary prevention of cardiovascular disease in patients who’ve had an MI. Dialysis for end-stage renal disease costs $50,000-$100,000 per quality-adjusted life-year gained.
When the DPP results first came out, "The reaction in the medical community was, ‘This is great, but we don’t have the resources to implement it,’ " Dr. Herman said. Controversy continued due to conflicting results from analyses that modeled cost effectiveness over time based on the 3-year results of the DPP. The current study used real-life cost data collected prospectively for the study period and the following 7 years.
The results show that for patients with prediabetes, "metformin is cost saving. Intensive lifestyle intervention, though not cost saving, is extremely cost effective," Dr. Herman said. "It represents good value for the money."
The DPP’s lifestyle intervention aimed for a 7% reduction in body weight and 150 minutes per week of moderately intense physical activity, usually 30 minutes per day of brisk walking 5 days per week. Patients were asked to attend 16 sessions in a 6-month period for nutritional and exercise guidance and received ongoing follow-up with a case manager. After 3 years, the incidence of diabetes was 58% lower in the lifestyle intervention group and 31% lower with metformin compared with the placebo group (N. Engl. J. Med. 2002;346:393-403). The diabetes incidence was 5 cases per 100 person-years in the lifestyle group compared with 8 in the metformin group, and 11 in the placebo group.
During the next 7 years, patients in the metformin group were encouraged to continue the medication, and those in the lifestyle intervention group were offered a less intensive lifestyle intervention with fewer individual sessions. At the 10-year mark, the risk for developing diabetes was 34% less in the lifestyle intervention group and 18% less in the metformin group compared with the control group, Dr. Herman said. Quality of life was rated significantly higher in the metformin group compared with the placebo group, and significantly higher in the lifestyle intervention group compared with the metformin or placebo groups.
Implementation of a lifestyle intervention should be as simple as writing a prescription for a pill to prevent diabetes, Dr. Herman suggested. One way to build access to lifestyle interventions might be to locate them in cardiac rehabilitation centers, which already contain the facilities needed for exercise and other components of the intervention.
"Translating these findings into practice will reduce the development of type 2 diabetes, which has become one of the most common and costly diseases," Dr. Griffin P. Rodgers said in a statement released by the American Diabetes Association. Dr. Rodgers is director of the National Institute of Diabetes and Digestive and Kidney Diseases.
The costs of lifestyle intervention to prevent diabetes will decline over time, Dr. Herman said. The data suggest that the DPP’s intensive lifestyle intervention can be adapted into a less-expensive, but still effective, group-based model without having to reinvent everything, he added. Instead of 16 sessions in 6 months, patients may have a yearly session with a dietician.
Dr. Herman has been a consultant for McKinsey & Company.
SAN DIEGO – Few medical interventions both improve health and save money. Treating prediabetes with metformin is one of them, according to 10-year follow-up data from the Diabetes Prevention Program.
Intensive lifestyle intervention, the other treatment arm in the randomized, placebo-controlled Diabetes Prevention Program (DPP) study, did an even better job at improving health and quality of life, and at a favorable cost when compared with some common medical interventions for other diagnoses, Dr. William H. Herman and his associates reported at the annual scientific sessions of the American Diabetes Association.
Most of the costs for the placebo group in the ensuing decade were related to conversion of subjects’ prediabetes to diabetes, explained Dr. Herman, professor of medicine and epidemiology at the University of Michigan, Ann Arbor.
At baseline, all 3,234 participants in the DPP were nondiabetic, were overweight or obese, and had impaired glucose tolerance and an elevated fasting glucose level.
Metformin treatment (850 mg b.i.d.) reduced overall costs for medical care in those 10 years by $1,700 per person, and lifestyle intervention reduced those costs by $2,600 per person. After factoring in the costs of the interventions, the researchers found that metformin treatment produced a savings of $30 per patient compared with placebo over the 10 years.
The cost-saving benefits of metformin for people at high risk of diabetes puts this preventive intervention in a league with prenatal care, pediatric immunizations, and influenza vaccinations for people older than 65 years, Dr. Herman said. Only 1 in 10 medical interventions are cost-saving, he noted.
With the lifestyle intervention, overall costs were $1,500 per person greater than placebo, a price tag that puts lifestyle intervention for prediabetes in a league with some of the most widely accepted medical interventions when converted for comparison into quality-adjusted life-years gained.
In simple terms, the cost for a quality-adjusted life-year gained is the price "to buy 1 year of life in essentially perfect health," he explained.
In this study, the cost per quality-adjusted life-year gained with the intensive lifestyle intervention compared with the placebo group was $12,000. That $12,000 is on the low end of a $10,000-$50,000 range that’s widely accepted for medical interventions, including the use of beta-blockers after MI, the use of antihypertensive therapy for patients with very high diastolic blood pressure (greater than 105 mm Hg), or the use of statins for secondary prevention of cardiovascular disease in patients who’ve had an MI. Dialysis for end-stage renal disease costs $50,000-$100,000 per quality-adjusted life-year gained.
When the DPP results first came out, "The reaction in the medical community was, ‘This is great, but we don’t have the resources to implement it,’ " Dr. Herman said. Controversy continued due to conflicting results from analyses that modeled cost effectiveness over time based on the 3-year results of the DPP. The current study used real-life cost data collected prospectively for the study period and the following 7 years.
The results show that for patients with prediabetes, "metformin is cost saving. Intensive lifestyle intervention, though not cost saving, is extremely cost effective," Dr. Herman said. "It represents good value for the money."
The DPP’s lifestyle intervention aimed for a 7% reduction in body weight and 150 minutes per week of moderately intense physical activity, usually 30 minutes per day of brisk walking 5 days per week. Patients were asked to attend 16 sessions in a 6-month period for nutritional and exercise guidance and received ongoing follow-up with a case manager. After 3 years, the incidence of diabetes was 58% lower in the lifestyle intervention group and 31% lower with metformin compared with the placebo group (N. Engl. J. Med. 2002;346:393-403). The diabetes incidence was 5 cases per 100 person-years in the lifestyle group compared with 8 in the metformin group, and 11 in the placebo group.
During the next 7 years, patients in the metformin group were encouraged to continue the medication, and those in the lifestyle intervention group were offered a less intensive lifestyle intervention with fewer individual sessions. At the 10-year mark, the risk for developing diabetes was 34% less in the lifestyle intervention group and 18% less in the metformin group compared with the control group, Dr. Herman said. Quality of life was rated significantly higher in the metformin group compared with the placebo group, and significantly higher in the lifestyle intervention group compared with the metformin or placebo groups.
Implementation of a lifestyle intervention should be as simple as writing a prescription for a pill to prevent diabetes, Dr. Herman suggested. One way to build access to lifestyle interventions might be to locate them in cardiac rehabilitation centers, which already contain the facilities needed for exercise and other components of the intervention.
"Translating these findings into practice will reduce the development of type 2 diabetes, which has become one of the most common and costly diseases," Dr. Griffin P. Rodgers said in a statement released by the American Diabetes Association. Dr. Rodgers is director of the National Institute of Diabetes and Digestive and Kidney Diseases.
The costs of lifestyle intervention to prevent diabetes will decline over time, Dr. Herman said. The data suggest that the DPP’s intensive lifestyle intervention can be adapted into a less-expensive, but still effective, group-based model without having to reinvent everything, he added. Instead of 16 sessions in 6 months, patients may have a yearly session with a dietician.
Dr. Herman has been a consultant for McKinsey & Company.
lifestyle intervention, Dr. William H. Herman, the American Diabetes Association,
lifestyle intervention, Dr. William H. Herman, the American Diabetes Association,
FROM THE ANNUAL SCIENTIFIC SESSIONS OF THE AMERICAN DIABETES ASSOCIATION
Major Finding: Over a 10-year period, the incidence of diabetes among people who were prediabetic at baseline was 18% lower among those treated with metformin and 34% lower among those in a lifestyle intervention, compared with individuals in a placebo-controlled group. Use of metformin reduced overall medical costs by $30 per patient. The lifestyle intervention was deemed cost effective at $1,500 per quality-adjusted life-year gained compared with placebo.
Data Source: Analysis of data from the 3-year Diabetes Prevention Program, which involved 3,234 people with prediabetes, plus 7 years of prospective follow-up in which they were encouraged to continue the interventions.
Disclosures: Dr. Herman has been a consultant for McKinsey & Company.
Big Shift Seen in Prescribing Patterns for Type 2 Diabetes
SAN DIEGO – Since the mid-2000s clinicians dramatically shifted away from prescribing rosiglitazone and pioglitazone in favor of other novel type 2 diabetes medications, results from a large, single-center suggest.
At the annual scientific sessions of the American Diabetes Association, Dr. Sanjeev N. Mehta presented findings from a study of electronic medical records at Joslin Diabetes Center, Boston, that evaluated 10-year prescribing patterns for rosiglitazone and pioglitazone, as well as uptake of novel drug classes (categorized as "other") approved between 2001 and 2010. The "other" group consisted of amylin analogs, GLP-1 analogs, DPP-IV inhibitors, and bile acid sequestrants. Insulin use was not studied, nor were medications introduced prior to 2001.
The analysis aimed to measure provider response to the 2007 FDA black box warning for rosiglitazone, which was implemented due to the drug’s association with adverse cardiovascular outcomes.
"Given the availability of these new drugs, there’s a need to better understand provider patterns reading the use of new and established medications, [including] responsiveness to FDA indications and safety warnings," said Dr. Mehta, a staff physician at Joslin Diabetes Center.
Electronic health records with integrated prescribing functionality "may best describe provider behaviors, as their content is not limited top patient claims," he added. "Further, the detailed clinical information may provide the information necessary to validate both patient conditions and health outcomes."
Eligible patients had a diagnosis of type 2 diabetes based on an algorithm that used ICD-9 codes and a field that specified diabetes type. If a medication was used and later resumed, he and his associates used the earliest start date. For validation they conducted a manual review of 60 random electronic medical records.
Over the 10-year study period, 7,846 patients with type 2 diabetes had 9,178 new prescriptions for rosiglitazone, pioglitazone, and other agents. After 2007, the number of new prescriptions for rosiglitazone and pioglitazone declined dramatically.
By 2010, new prescriptions for rosiglitazone and pioglitazone were at 7% and 47%, respectively, of peak levels. The relative proportion of prescriptions for rosiglitazone, pioglitazone, and other medications was 44%, 50%, and 6% in 2005 and 2%, 18%, and 80% in 2010.
"Prescribing patterns may be described using EHR-based clinical data," Dr. Mehta concluded. "The data suggest provider responsiveness to an FDA warning for an established medication, as well as rapid adoption of new drugs and drug classes during this period. However, the explanation for provider behaviors cannot be fully determined in the present analysis, but merit further investigation."
Dr. Mehta said that he had no relevant financial conflicts to disclose.
SAN DIEGO – Since the mid-2000s clinicians dramatically shifted away from prescribing rosiglitazone and pioglitazone in favor of other novel type 2 diabetes medications, results from a large, single-center suggest.
At the annual scientific sessions of the American Diabetes Association, Dr. Sanjeev N. Mehta presented findings from a study of electronic medical records at Joslin Diabetes Center, Boston, that evaluated 10-year prescribing patterns for rosiglitazone and pioglitazone, as well as uptake of novel drug classes (categorized as "other") approved between 2001 and 2010. The "other" group consisted of amylin analogs, GLP-1 analogs, DPP-IV inhibitors, and bile acid sequestrants. Insulin use was not studied, nor were medications introduced prior to 2001.
The analysis aimed to measure provider response to the 2007 FDA black box warning for rosiglitazone, which was implemented due to the drug’s association with adverse cardiovascular outcomes.
"Given the availability of these new drugs, there’s a need to better understand provider patterns reading the use of new and established medications, [including] responsiveness to FDA indications and safety warnings," said Dr. Mehta, a staff physician at Joslin Diabetes Center.
Electronic health records with integrated prescribing functionality "may best describe provider behaviors, as their content is not limited top patient claims," he added. "Further, the detailed clinical information may provide the information necessary to validate both patient conditions and health outcomes."
Eligible patients had a diagnosis of type 2 diabetes based on an algorithm that used ICD-9 codes and a field that specified diabetes type. If a medication was used and later resumed, he and his associates used the earliest start date. For validation they conducted a manual review of 60 random electronic medical records.
Over the 10-year study period, 7,846 patients with type 2 diabetes had 9,178 new prescriptions for rosiglitazone, pioglitazone, and other agents. After 2007, the number of new prescriptions for rosiglitazone and pioglitazone declined dramatically.
By 2010, new prescriptions for rosiglitazone and pioglitazone were at 7% and 47%, respectively, of peak levels. The relative proportion of prescriptions for rosiglitazone, pioglitazone, and other medications was 44%, 50%, and 6% in 2005 and 2%, 18%, and 80% in 2010.
"Prescribing patterns may be described using EHR-based clinical data," Dr. Mehta concluded. "The data suggest provider responsiveness to an FDA warning for an established medication, as well as rapid adoption of new drugs and drug classes during this period. However, the explanation for provider behaviors cannot be fully determined in the present analysis, but merit further investigation."
Dr. Mehta said that he had no relevant financial conflicts to disclose.
SAN DIEGO – Since the mid-2000s clinicians dramatically shifted away from prescribing rosiglitazone and pioglitazone in favor of other novel type 2 diabetes medications, results from a large, single-center suggest.
At the annual scientific sessions of the American Diabetes Association, Dr. Sanjeev N. Mehta presented findings from a study of electronic medical records at Joslin Diabetes Center, Boston, that evaluated 10-year prescribing patterns for rosiglitazone and pioglitazone, as well as uptake of novel drug classes (categorized as "other") approved between 2001 and 2010. The "other" group consisted of amylin analogs, GLP-1 analogs, DPP-IV inhibitors, and bile acid sequestrants. Insulin use was not studied, nor were medications introduced prior to 2001.
The analysis aimed to measure provider response to the 2007 FDA black box warning for rosiglitazone, which was implemented due to the drug’s association with adverse cardiovascular outcomes.
"Given the availability of these new drugs, there’s a need to better understand provider patterns reading the use of new and established medications, [including] responsiveness to FDA indications and safety warnings," said Dr. Mehta, a staff physician at Joslin Diabetes Center.
Electronic health records with integrated prescribing functionality "may best describe provider behaviors, as their content is not limited top patient claims," he added. "Further, the detailed clinical information may provide the information necessary to validate both patient conditions and health outcomes."
Eligible patients had a diagnosis of type 2 diabetes based on an algorithm that used ICD-9 codes and a field that specified diabetes type. If a medication was used and later resumed, he and his associates used the earliest start date. For validation they conducted a manual review of 60 random electronic medical records.
Over the 10-year study period, 7,846 patients with type 2 diabetes had 9,178 new prescriptions for rosiglitazone, pioglitazone, and other agents. After 2007, the number of new prescriptions for rosiglitazone and pioglitazone declined dramatically.
By 2010, new prescriptions for rosiglitazone and pioglitazone were at 7% and 47%, respectively, of peak levels. The relative proportion of prescriptions for rosiglitazone, pioglitazone, and other medications was 44%, 50%, and 6% in 2005 and 2%, 18%, and 80% in 2010.
"Prescribing patterns may be described using EHR-based clinical data," Dr. Mehta concluded. "The data suggest provider responsiveness to an FDA warning for an established medication, as well as rapid adoption of new drugs and drug classes during this period. However, the explanation for provider behaviors cannot be fully determined in the present analysis, but merit further investigation."
Dr. Mehta said that he had no relevant financial conflicts to disclose.
FROM THE ANNUAL SCIENTIFIC SESSIONS OF THE AMERICAN DIABETES ASSOCIATION
Major Finding: The relative proportion of prescriptions for rosiglitazone, pioglitazone, and other medications was 44%, 50%, and 6% in 2005 and 2%, 18%, and 80% in 2010.
Data Source: A study of 7,846 patients with type 2 diabetes at the Joslin Diabetes Center, Boston, who had 9,178 new prescriptions for rosiglitazone, pioglitazone, and other agents from 2001-2010.
Disclosures: Dr. Mehta said that he had no relevant financial conflicts to disclose.
Big Shift Seen in Prescribing Patterns for Type 2 Diabetes
SAN DIEGO – Since the mid-2000s clinicians dramatically shifted away from prescribing rosiglitazone and pioglitazone in favor of other novel type 2 diabetes medications, results from a large, single-center suggest.
At the annual scientific sessions of the American Diabetes Association, Dr. Sanjeev N. Mehta presented findings from a study of electronic medical records at Joslin Diabetes Center, Boston, that evaluated 10-year prescribing patterns for rosiglitazone and pioglitazone, as well as uptake of novel drug classes (categorized as "other") approved between 2001 and 2010. The "other" group consisted of amylin analogs, GLP-1 analogs, DPP-IV inhibitors, and bile acid sequestrants. Insulin use was not studied, nor were medications introduced prior to 2001.
The analysis aimed to measure provider response to the 2007 FDA black box warning for rosiglitazone, which was implemented due to the drug’s association with adverse cardiovascular outcomes.
"Given the availability of these new drugs, there’s a need to better understand provider patterns reading the use of new and established medications, [including] responsiveness to FDA indications and safety warnings," said Dr. Mehta, a staff physician at Joslin Diabetes Center.
Electronic health records with integrated prescribing functionality "may best describe provider behaviors, as their content is not limited top patient claims," he added. "Further, the detailed clinical information may provide the information necessary to validate both patient conditions and health outcomes."
Eligible patients had a diagnosis of type 2 diabetes based on an algorithm that used ICD-9 codes and a field that specified diabetes type. If a medication was used and later resumed, he and his associates used the earliest start date. For validation they conducted a manual review of 60 random electronic medical records.
Over the 10-year study period, 7,846 patients with type 2 diabetes had 9,178 new prescriptions for rosiglitazone, pioglitazone, and other agents. After 2007, the number of new prescriptions for rosiglitazone and pioglitazone declined dramatically.
By 2010, new prescriptions for rosiglitazone and pioglitazone were at 7% and 47%, respectively, of peak levels. The relative proportion of prescriptions for rosiglitazone, pioglitazone, and other medications was 44%, 50%, and 6% in 2005 and 2%, 18%, and 80% in 2010.
"Prescribing patterns may be described using EHR-based clinical data," Dr. Mehta concluded. "The data suggest provider responsiveness to an FDA warning for an established medication, as well as rapid adoption of new drugs and drug classes during this period. However, the explanation for provider behaviors cannot be fully determined in the present analysis, but merit further investigation."
Dr. Mehta said that he had no relevant financial conflicts to disclose.
SAN DIEGO – Since the mid-2000s clinicians dramatically shifted away from prescribing rosiglitazone and pioglitazone in favor of other novel type 2 diabetes medications, results from a large, single-center suggest.
At the annual scientific sessions of the American Diabetes Association, Dr. Sanjeev N. Mehta presented findings from a study of electronic medical records at Joslin Diabetes Center, Boston, that evaluated 10-year prescribing patterns for rosiglitazone and pioglitazone, as well as uptake of novel drug classes (categorized as "other") approved between 2001 and 2010. The "other" group consisted of amylin analogs, GLP-1 analogs, DPP-IV inhibitors, and bile acid sequestrants. Insulin use was not studied, nor were medications introduced prior to 2001.
The analysis aimed to measure provider response to the 2007 FDA black box warning for rosiglitazone, which was implemented due to the drug’s association with adverse cardiovascular outcomes.
"Given the availability of these new drugs, there’s a need to better understand provider patterns reading the use of new and established medications, [including] responsiveness to FDA indications and safety warnings," said Dr. Mehta, a staff physician at Joslin Diabetes Center.
Electronic health records with integrated prescribing functionality "may best describe provider behaviors, as their content is not limited top patient claims," he added. "Further, the detailed clinical information may provide the information necessary to validate both patient conditions and health outcomes."
Eligible patients had a diagnosis of type 2 diabetes based on an algorithm that used ICD-9 codes and a field that specified diabetes type. If a medication was used and later resumed, he and his associates used the earliest start date. For validation they conducted a manual review of 60 random electronic medical records.
Over the 10-year study period, 7,846 patients with type 2 diabetes had 9,178 new prescriptions for rosiglitazone, pioglitazone, and other agents. After 2007, the number of new prescriptions for rosiglitazone and pioglitazone declined dramatically.
By 2010, new prescriptions for rosiglitazone and pioglitazone were at 7% and 47%, respectively, of peak levels. The relative proportion of prescriptions for rosiglitazone, pioglitazone, and other medications was 44%, 50%, and 6% in 2005 and 2%, 18%, and 80% in 2010.
"Prescribing patterns may be described using EHR-based clinical data," Dr. Mehta concluded. "The data suggest provider responsiveness to an FDA warning for an established medication, as well as rapid adoption of new drugs and drug classes during this period. However, the explanation for provider behaviors cannot be fully determined in the present analysis, but merit further investigation."
Dr. Mehta said that he had no relevant financial conflicts to disclose.
SAN DIEGO – Since the mid-2000s clinicians dramatically shifted away from prescribing rosiglitazone and pioglitazone in favor of other novel type 2 diabetes medications, results from a large, single-center suggest.
At the annual scientific sessions of the American Diabetes Association, Dr. Sanjeev N. Mehta presented findings from a study of electronic medical records at Joslin Diabetes Center, Boston, that evaluated 10-year prescribing patterns for rosiglitazone and pioglitazone, as well as uptake of novel drug classes (categorized as "other") approved between 2001 and 2010. The "other" group consisted of amylin analogs, GLP-1 analogs, DPP-IV inhibitors, and bile acid sequestrants. Insulin use was not studied, nor were medications introduced prior to 2001.
The analysis aimed to measure provider response to the 2007 FDA black box warning for rosiglitazone, which was implemented due to the drug’s association with adverse cardiovascular outcomes.
"Given the availability of these new drugs, there’s a need to better understand provider patterns reading the use of new and established medications, [including] responsiveness to FDA indications and safety warnings," said Dr. Mehta, a staff physician at Joslin Diabetes Center.
Electronic health records with integrated prescribing functionality "may best describe provider behaviors, as their content is not limited top patient claims," he added. "Further, the detailed clinical information may provide the information necessary to validate both patient conditions and health outcomes."
Eligible patients had a diagnosis of type 2 diabetes based on an algorithm that used ICD-9 codes and a field that specified diabetes type. If a medication was used and later resumed, he and his associates used the earliest start date. For validation they conducted a manual review of 60 random electronic medical records.
Over the 10-year study period, 7,846 patients with type 2 diabetes had 9,178 new prescriptions for rosiglitazone, pioglitazone, and other agents. After 2007, the number of new prescriptions for rosiglitazone and pioglitazone declined dramatically.
By 2010, new prescriptions for rosiglitazone and pioglitazone were at 7% and 47%, respectively, of peak levels. The relative proportion of prescriptions for rosiglitazone, pioglitazone, and other medications was 44%, 50%, and 6% in 2005 and 2%, 18%, and 80% in 2010.
"Prescribing patterns may be described using EHR-based clinical data," Dr. Mehta concluded. "The data suggest provider responsiveness to an FDA warning for an established medication, as well as rapid adoption of new drugs and drug classes during this period. However, the explanation for provider behaviors cannot be fully determined in the present analysis, but merit further investigation."
Dr. Mehta said that he had no relevant financial conflicts to disclose.
FROM THE ANNUAL SCIENTIFIC SESSIONS OF THE AMERICAN DIABETES ASSOCIATION
Major Finding: The relative proportion of prescriptions for rosiglitazone, pioglitazone, and other medications was 44%, 50%, and 6% in 2005 and 2%, 18%, and 80% in 2010.
Data Source: A study of 7,846 patients with type 2 diabetes at the Joslin Diabetes Center, Boston, who had 9,178 new prescriptions for rosiglitazone, pioglitazone, and other agents from 2001-2010.
Disclosures: Dr. Mehta said that he had no relevant financial conflicts to disclose.
HbA1c Plus Fasting Glucose More Accurately Identifies Prediabetes
SAN DIEGO – Having a hemoglobin A1c level of 5.7%-6.4% or impaired fasting glucose each predicted a sixfold higher risk for developing diabetes among individuals screened for the disease, and people who meet both criteria are at a 32-fold increased risk for diabetes, compared with normoglycemic individuals, a large longitudinal study found.
Using the two tests together could better identify people who are most likely to progress to diabetes and who could therefore benefit from early interventions, Yoriko Heianza and her associates reported at the annual scientific sessions of the American Diabetes Association. The findings simultaneously were published online (Lancet 2011 [doi:10.1016/S0140-6736(11)60472-8]).
The study followed 6,241 Japanese subjects, most of whom were government employees and who did not have diabetes at the time of their annual health screenings between 1997 and 2003, and who had annual exams for the next 4-5 years. During that time, 5% developed diabetes, an incidence similar to that in the general Japanese population.
At the baseline exam, 2,092 (34%) were diagnosed with prediabetes. Of those, nearly 20% were diagnosed with prediabetes solely on the basis of an HBA1c level of 5.7%-6.4% and 61% were diagnosed solely based on impaired fasting glucose, defined as a fasting plasma glucose concentration of 5.6-6.9 mmol/L. The remaining nearly 20% met both criteria for prediabetes, reported Ms. Heianza of the University of Tsukuba (Japan) Institute of Clinical Medicine and Toranomon Hospital, Tokyo.
Only half of the people who were diagnosed with prediabetes based on HbA1c level also had impaired fasting glucose, and only 24% of people diagnosed by impaired fasting glucose also met the HbA1c criterion.
Although the HbA1c test identified fewer individuals with prediabetes (822) than did impaired fasting glucose (1,680), the predictive power for progression to diabetes was similar between tests. Once diagnosed with prediabetes with either test, the risk for developing diabetes was six-fold higher than in normoglycemic individuals, after adjusting for the effects of age, sex, and other factors.
Meeting both criteria significantly increased the risk of developing diabetes to a level 32 times higher than in normoglycemic participants. The predictive power of using both tests is multiplied rather than simply additive, the investigators suggested.
The discordance between prediabetes diagnoses made by either HbA1c level or impaired fasting glucose in this study was similar to results from the U.S. National Health and Nutrition Examination Survey (NHANES), they added. In the current study, 19.7% met the HbA1c criterion for prediabetes without having impaired fasting glucose, compared with 17% in the NHANES data. In NHANES, the HbA1c test had a 27% sensitivity and a 93% specificity for diagnosing prediabetes, compared with a sensitivity of 21% and a specificity of 91% in the Japanese cohort.
Subjects in the Japanese study ranged in age from 24-82 years, with a mean age of 50 years; 75% were men.
Differences in baseline characteristics made up different cardiovascular risk profiles between individuals diagnosed with prediabetes solely based on HbA1c level or impaired fasting glucose. People diagnosed with prediabetes solely on the HbA1c criterion were more likely to be female and older, and less likely to be hypertensive or obese. They also had lower levels of triglyceride, uric acid, and HDL cholesterol.
The investigators reported having no conflicts of interest. The study was funded in part by Japan’s Ministry of Health, Labor and Welfare.
The findings further the debate about the use of HbA1c to diagnose diabetes and prediabetes, according to Dr. Anoop Misra and Dr. Satish Garg.
Most important, the fact that using both tests identified more high-risk individuals suggests that they play unique roles in predicting diabetes. Impaired fasting glucose is caused mainly by hepatic insulin resistance. HbA1c reflects chronic exposure to basal and postprandial hyperglycemia. Impaired glucose tolerance indicates muscle insulin resistance. Data for oral glucose tolerance tests were not available in the study. Those three tests may identify different risk phenotypes because they represent different facets of glucose metabolism, they said.
The HbA1c test seems to have lower sensitivity but is fairly specific, compared with glucose-based diagnostic tests, Dr. Misra and Dr. Garg noted.
Many physicians argue that use of HbA1c to diagnose diabetes and prediabetes is premature, however, especially in resource-poor developing countries, because of difficulty interpreting it in certain clinical situations, in different ethnic groups, in children or adolescents, and in older people.
Widespread use of HbA1c would reclassify 50 million "healthy" adults in the United States alone as prediabetic, they added. That would have enormous implications for health care systems that have not prepared to manage this population.
Dr. Misra is with Fortis Hospital in New Delhi, and Dr. Garg is with the University of Colorado Denver, Aurora. They reported having no conflicts of interest. Their comments were taken from an accompanying editorial (Lancet 2011 [doi:10.1016/S0140-6736(11)60789-7]).
The findings further the debate about the use of HbA1c to diagnose diabetes and prediabetes, according to Dr. Anoop Misra and Dr. Satish Garg.
Most important, the fact that using both tests identified more high-risk individuals suggests that they play unique roles in predicting diabetes. Impaired fasting glucose is caused mainly by hepatic insulin resistance. HbA1c reflects chronic exposure to basal and postprandial hyperglycemia. Impaired glucose tolerance indicates muscle insulin resistance. Data for oral glucose tolerance tests were not available in the study. Those three tests may identify different risk phenotypes because they represent different facets of glucose metabolism, they said.
The HbA1c test seems to have lower sensitivity but is fairly specific, compared with glucose-based diagnostic tests, Dr. Misra and Dr. Garg noted.
Many physicians argue that use of HbA1c to diagnose diabetes and prediabetes is premature, however, especially in resource-poor developing countries, because of difficulty interpreting it in certain clinical situations, in different ethnic groups, in children or adolescents, and in older people.
Widespread use of HbA1c would reclassify 50 million "healthy" adults in the United States alone as prediabetic, they added. That would have enormous implications for health care systems that have not prepared to manage this population.
Dr. Misra is with Fortis Hospital in New Delhi, and Dr. Garg is with the University of Colorado Denver, Aurora. They reported having no conflicts of interest. Their comments were taken from an accompanying editorial (Lancet 2011 [doi:10.1016/S0140-6736(11)60789-7]).
The findings further the debate about the use of HbA1c to diagnose diabetes and prediabetes, according to Dr. Anoop Misra and Dr. Satish Garg.
Most important, the fact that using both tests identified more high-risk individuals suggests that they play unique roles in predicting diabetes. Impaired fasting glucose is caused mainly by hepatic insulin resistance. HbA1c reflects chronic exposure to basal and postprandial hyperglycemia. Impaired glucose tolerance indicates muscle insulin resistance. Data for oral glucose tolerance tests were not available in the study. Those three tests may identify different risk phenotypes because they represent different facets of glucose metabolism, they said.
The HbA1c test seems to have lower sensitivity but is fairly specific, compared with glucose-based diagnostic tests, Dr. Misra and Dr. Garg noted.
Many physicians argue that use of HbA1c to diagnose diabetes and prediabetes is premature, however, especially in resource-poor developing countries, because of difficulty interpreting it in certain clinical situations, in different ethnic groups, in children or adolescents, and in older people.
Widespread use of HbA1c would reclassify 50 million "healthy" adults in the United States alone as prediabetic, they added. That would have enormous implications for health care systems that have not prepared to manage this population.
Dr. Misra is with Fortis Hospital in New Delhi, and Dr. Garg is with the University of Colorado Denver, Aurora. They reported having no conflicts of interest. Their comments were taken from an accompanying editorial (Lancet 2011 [doi:10.1016/S0140-6736(11)60789-7]).
SAN DIEGO – Having a hemoglobin A1c level of 5.7%-6.4% or impaired fasting glucose each predicted a sixfold higher risk for developing diabetes among individuals screened for the disease, and people who meet both criteria are at a 32-fold increased risk for diabetes, compared with normoglycemic individuals, a large longitudinal study found.
Using the two tests together could better identify people who are most likely to progress to diabetes and who could therefore benefit from early interventions, Yoriko Heianza and her associates reported at the annual scientific sessions of the American Diabetes Association. The findings simultaneously were published online (Lancet 2011 [doi:10.1016/S0140-6736(11)60472-8]).
The study followed 6,241 Japanese subjects, most of whom were government employees and who did not have diabetes at the time of their annual health screenings between 1997 and 2003, and who had annual exams for the next 4-5 years. During that time, 5% developed diabetes, an incidence similar to that in the general Japanese population.
At the baseline exam, 2,092 (34%) were diagnosed with prediabetes. Of those, nearly 20% were diagnosed with prediabetes solely on the basis of an HBA1c level of 5.7%-6.4% and 61% were diagnosed solely based on impaired fasting glucose, defined as a fasting plasma glucose concentration of 5.6-6.9 mmol/L. The remaining nearly 20% met both criteria for prediabetes, reported Ms. Heianza of the University of Tsukuba (Japan) Institute of Clinical Medicine and Toranomon Hospital, Tokyo.
Only half of the people who were diagnosed with prediabetes based on HbA1c level also had impaired fasting glucose, and only 24% of people diagnosed by impaired fasting glucose also met the HbA1c criterion.
Although the HbA1c test identified fewer individuals with prediabetes (822) than did impaired fasting glucose (1,680), the predictive power for progression to diabetes was similar between tests. Once diagnosed with prediabetes with either test, the risk for developing diabetes was six-fold higher than in normoglycemic individuals, after adjusting for the effects of age, sex, and other factors.
Meeting both criteria significantly increased the risk of developing diabetes to a level 32 times higher than in normoglycemic participants. The predictive power of using both tests is multiplied rather than simply additive, the investigators suggested.
The discordance between prediabetes diagnoses made by either HbA1c level or impaired fasting glucose in this study was similar to results from the U.S. National Health and Nutrition Examination Survey (NHANES), they added. In the current study, 19.7% met the HbA1c criterion for prediabetes without having impaired fasting glucose, compared with 17% in the NHANES data. In NHANES, the HbA1c test had a 27% sensitivity and a 93% specificity for diagnosing prediabetes, compared with a sensitivity of 21% and a specificity of 91% in the Japanese cohort.
Subjects in the Japanese study ranged in age from 24-82 years, with a mean age of 50 years; 75% were men.
Differences in baseline characteristics made up different cardiovascular risk profiles between individuals diagnosed with prediabetes solely based on HbA1c level or impaired fasting glucose. People diagnosed with prediabetes solely on the HbA1c criterion were more likely to be female and older, and less likely to be hypertensive or obese. They also had lower levels of triglyceride, uric acid, and HDL cholesterol.
The investigators reported having no conflicts of interest. The study was funded in part by Japan’s Ministry of Health, Labor and Welfare.
SAN DIEGO – Having a hemoglobin A1c level of 5.7%-6.4% or impaired fasting glucose each predicted a sixfold higher risk for developing diabetes among individuals screened for the disease, and people who meet both criteria are at a 32-fold increased risk for diabetes, compared with normoglycemic individuals, a large longitudinal study found.
Using the two tests together could better identify people who are most likely to progress to diabetes and who could therefore benefit from early interventions, Yoriko Heianza and her associates reported at the annual scientific sessions of the American Diabetes Association. The findings simultaneously were published online (Lancet 2011 [doi:10.1016/S0140-6736(11)60472-8]).
The study followed 6,241 Japanese subjects, most of whom were government employees and who did not have diabetes at the time of their annual health screenings between 1997 and 2003, and who had annual exams for the next 4-5 years. During that time, 5% developed diabetes, an incidence similar to that in the general Japanese population.
At the baseline exam, 2,092 (34%) were diagnosed with prediabetes. Of those, nearly 20% were diagnosed with prediabetes solely on the basis of an HBA1c level of 5.7%-6.4% and 61% were diagnosed solely based on impaired fasting glucose, defined as a fasting plasma glucose concentration of 5.6-6.9 mmol/L. The remaining nearly 20% met both criteria for prediabetes, reported Ms. Heianza of the University of Tsukuba (Japan) Institute of Clinical Medicine and Toranomon Hospital, Tokyo.
Only half of the people who were diagnosed with prediabetes based on HbA1c level also had impaired fasting glucose, and only 24% of people diagnosed by impaired fasting glucose also met the HbA1c criterion.
Although the HbA1c test identified fewer individuals with prediabetes (822) than did impaired fasting glucose (1,680), the predictive power for progression to diabetes was similar between tests. Once diagnosed with prediabetes with either test, the risk for developing diabetes was six-fold higher than in normoglycemic individuals, after adjusting for the effects of age, sex, and other factors.
Meeting both criteria significantly increased the risk of developing diabetes to a level 32 times higher than in normoglycemic participants. The predictive power of using both tests is multiplied rather than simply additive, the investigators suggested.
The discordance between prediabetes diagnoses made by either HbA1c level or impaired fasting glucose in this study was similar to results from the U.S. National Health and Nutrition Examination Survey (NHANES), they added. In the current study, 19.7% met the HbA1c criterion for prediabetes without having impaired fasting glucose, compared with 17% in the NHANES data. In NHANES, the HbA1c test had a 27% sensitivity and a 93% specificity for diagnosing prediabetes, compared with a sensitivity of 21% and a specificity of 91% in the Japanese cohort.
Subjects in the Japanese study ranged in age from 24-82 years, with a mean age of 50 years; 75% were men.
Differences in baseline characteristics made up different cardiovascular risk profiles between individuals diagnosed with prediabetes solely based on HbA1c level or impaired fasting glucose. People diagnosed with prediabetes solely on the HbA1c criterion were more likely to be female and older, and less likely to be hypertensive or obese. They also had lower levels of triglyceride, uric acid, and HDL cholesterol.
The investigators reported having no conflicts of interest. The study was funded in part by Japan’s Ministry of Health, Labor and Welfare.
FROM THE ANNUAL SCIENTIFIC SESSIONS OF THE AMERICAN DIABETES ASSOCIATION
Major Finding: Having an HbA1c level of 5.7%-6.4% or impaired fasting glucose each predicted a sixfold higher risk for developing diabetes among people screened for the disease, and people who meet both criteria were at a 32-fold increased risk for diabetes, compared with normoglycemic individuals.
Data Source: Longitudinal cohort study in 6,241 Japanese people without diabetes when they presented for routine health checks who were followed for a mean of 5 years.
Disclosures: The investigators reported having no conflicts of interest. The study was funded in part by Japan’s Ministry of Health, Labor and Welfare.
HbA1c Plus Fasting Glucose More Accurately Identifies Prediabetes
SAN DIEGO – Having a hemoglobin A1c level of 5.7%-6.4% or impaired fasting glucose each predicted a sixfold higher risk for developing diabetes among individuals screened for the disease, and people who meet both criteria are at a 32-fold increased risk for diabetes, compared with normoglycemic individuals, a large longitudinal study found.
Using the two tests together could better identify people who are most likely to progress to diabetes and who could therefore benefit from early interventions, Yoriko Heianza and her associates reported at the annual scientific sessions of the American Diabetes Association. The findings simultaneously were published online (Lancet 2011 [doi:10.1016/S0140-6736(11)60472-8]).
The study followed 6,241 Japanese subjects, most of whom were government employees and who did not have diabetes at the time of their annual health screenings between 1997 and 2003, and who had annual exams for the next 4-5 years. During that time, 5% developed diabetes, an incidence similar to that in the general Japanese population.
At the baseline exam, 2,092 (34%) were diagnosed with prediabetes. Of those, nearly 20% were diagnosed with prediabetes solely on the basis of an HBA1c level of 5.7%-6.4% and 61% were diagnosed solely based on impaired fasting glucose, defined as a fasting plasma glucose concentration of 5.6-6.9 mmol/L. The remaining nearly 20% met both criteria for prediabetes, reported Ms. Heianza of the University of Tsukuba (Japan) Institute of Clinical Medicine and Toranomon Hospital, Tokyo.
Only half of the people who were diagnosed with prediabetes based on HbA1c level also had impaired fasting glucose, and only 24% of people diagnosed by impaired fasting glucose also met the HbA1c criterion.
Although the HbA1c test identified fewer individuals with prediabetes (822) than did impaired fasting glucose (1,680), the predictive power for progression to diabetes was similar between tests. Once diagnosed with prediabetes with either test, the risk for developing diabetes was six-fold higher than in normoglycemic individuals, after adjusting for the effects of age, sex, and other factors.
Meeting both criteria significantly increased the risk of developing diabetes to a level 32 times higher than in normoglycemic participants. The predictive power of using both tests is multiplied rather than simply additive, the investigators suggested.
The discordance between prediabetes diagnoses made by either HbA1c level or impaired fasting glucose in this study was similar to results from the U.S. National Health and Nutrition Examination Survey (NHANES), they added. In the current study, 19.7% met the HbA1c criterion for prediabetes without having impaired fasting glucose, compared with 17% in the NHANES data. In NHANES, the HbA1c test had a 27% sensitivity and a 93% specificity for diagnosing prediabetes, compared with a sensitivity of 21% and a specificity of 91% in the Japanese cohort.
Subjects in the Japanese study ranged in age from 24-82 years, with a mean age of 50 years; 75% were men.
Differences in baseline characteristics made up different cardiovascular risk profiles between individuals diagnosed with prediabetes solely based on HbA1c level or impaired fasting glucose. People diagnosed with prediabetes solely on the HbA1c criterion were more likely to be female and older, and less likely to be hypertensive or obese. They also had lower levels of triglyceride, uric acid, and HDL cholesterol.
The investigators reported having no conflicts of interest. The study was funded in part by Japan’s Ministry of Health, Labor and Welfare.
The findings further the debate about the use of HbA1c to diagnose diabetes and prediabetes, according to Dr. Anoop Misra and Dr. Satish Garg.
Most important, the fact that using both tests identified more high-risk individuals suggests that they play unique roles in predicting diabetes. Impaired fasting glucose is caused mainly by hepatic insulin resistance. HbA1c reflects chronic exposure to basal and postprandial hyperglycemia. Impaired glucose tolerance indicates muscle insulin resistance. Data for oral glucose tolerance tests were not available in the study. Those three tests may identify different risk phenotypes because they represent different facets of glucose metabolism, they said.
The HbA1c test seems to have lower sensitivity but is fairly specific, compared with glucose-based diagnostic tests, Dr. Misra and Dr. Garg noted.
Many physicians argue that use of HbA1c to diagnose diabetes and prediabetes is premature, however, especially in resource-poor developing countries, because of difficulty interpreting it in certain clinical situations, in different ethnic groups, in children or adolescents, and in older people.
Widespread use of HbA1c would reclassify 50 million "healthy" adults in the United States alone as prediabetic, they added. That would have enormous implications for health care systems that have not prepared to manage this population.
Dr. Misra is with Fortis Hospital in New Delhi, and Dr. Garg is with the University of Colorado Denver, Aurora. They reported having no conflicts of interest. Their comments were taken from an accompanying editorial (Lancet 2011 [doi:10.1016/S0140-6736(11)60789-7]).
The findings further the debate about the use of HbA1c to diagnose diabetes and prediabetes, according to Dr. Anoop Misra and Dr. Satish Garg.
Most important, the fact that using both tests identified more high-risk individuals suggests that they play unique roles in predicting diabetes. Impaired fasting glucose is caused mainly by hepatic insulin resistance. HbA1c reflects chronic exposure to basal and postprandial hyperglycemia. Impaired glucose tolerance indicates muscle insulin resistance. Data for oral glucose tolerance tests were not available in the study. Those three tests may identify different risk phenotypes because they represent different facets of glucose metabolism, they said.
The HbA1c test seems to have lower sensitivity but is fairly specific, compared with glucose-based diagnostic tests, Dr. Misra and Dr. Garg noted.
Many physicians argue that use of HbA1c to diagnose diabetes and prediabetes is premature, however, especially in resource-poor developing countries, because of difficulty interpreting it in certain clinical situations, in different ethnic groups, in children or adolescents, and in older people.
Widespread use of HbA1c would reclassify 50 million "healthy" adults in the United States alone as prediabetic, they added. That would have enormous implications for health care systems that have not prepared to manage this population.
Dr. Misra is with Fortis Hospital in New Delhi, and Dr. Garg is with the University of Colorado Denver, Aurora. They reported having no conflicts of interest. Their comments were taken from an accompanying editorial (Lancet 2011 [doi:10.1016/S0140-6736(11)60789-7]).
The findings further the debate about the use of HbA1c to diagnose diabetes and prediabetes, according to Dr. Anoop Misra and Dr. Satish Garg.
Most important, the fact that using both tests identified more high-risk individuals suggests that they play unique roles in predicting diabetes. Impaired fasting glucose is caused mainly by hepatic insulin resistance. HbA1c reflects chronic exposure to basal and postprandial hyperglycemia. Impaired glucose tolerance indicates muscle insulin resistance. Data for oral glucose tolerance tests were not available in the study. Those three tests may identify different risk phenotypes because they represent different facets of glucose metabolism, they said.
The HbA1c test seems to have lower sensitivity but is fairly specific, compared with glucose-based diagnostic tests, Dr. Misra and Dr. Garg noted.
Many physicians argue that use of HbA1c to diagnose diabetes and prediabetes is premature, however, especially in resource-poor developing countries, because of difficulty interpreting it in certain clinical situations, in different ethnic groups, in children or adolescents, and in older people.
Widespread use of HbA1c would reclassify 50 million "healthy" adults in the United States alone as prediabetic, they added. That would have enormous implications for health care systems that have not prepared to manage this population.
Dr. Misra is with Fortis Hospital in New Delhi, and Dr. Garg is with the University of Colorado Denver, Aurora. They reported having no conflicts of interest. Their comments were taken from an accompanying editorial (Lancet 2011 [doi:10.1016/S0140-6736(11)60789-7]).
SAN DIEGO – Having a hemoglobin A1c level of 5.7%-6.4% or impaired fasting glucose each predicted a sixfold higher risk for developing diabetes among individuals screened for the disease, and people who meet both criteria are at a 32-fold increased risk for diabetes, compared with normoglycemic individuals, a large longitudinal study found.
Using the two tests together could better identify people who are most likely to progress to diabetes and who could therefore benefit from early interventions, Yoriko Heianza and her associates reported at the annual scientific sessions of the American Diabetes Association. The findings simultaneously were published online (Lancet 2011 [doi:10.1016/S0140-6736(11)60472-8]).
The study followed 6,241 Japanese subjects, most of whom were government employees and who did not have diabetes at the time of their annual health screenings between 1997 and 2003, and who had annual exams for the next 4-5 years. During that time, 5% developed diabetes, an incidence similar to that in the general Japanese population.
At the baseline exam, 2,092 (34%) were diagnosed with prediabetes. Of those, nearly 20% were diagnosed with prediabetes solely on the basis of an HBA1c level of 5.7%-6.4% and 61% were diagnosed solely based on impaired fasting glucose, defined as a fasting plasma glucose concentration of 5.6-6.9 mmol/L. The remaining nearly 20% met both criteria for prediabetes, reported Ms. Heianza of the University of Tsukuba (Japan) Institute of Clinical Medicine and Toranomon Hospital, Tokyo.
Only half of the people who were diagnosed with prediabetes based on HbA1c level also had impaired fasting glucose, and only 24% of people diagnosed by impaired fasting glucose also met the HbA1c criterion.
Although the HbA1c test identified fewer individuals with prediabetes (822) than did impaired fasting glucose (1,680), the predictive power for progression to diabetes was similar between tests. Once diagnosed with prediabetes with either test, the risk for developing diabetes was six-fold higher than in normoglycemic individuals, after adjusting for the effects of age, sex, and other factors.
Meeting both criteria significantly increased the risk of developing diabetes to a level 32 times higher than in normoglycemic participants. The predictive power of using both tests is multiplied rather than simply additive, the investigators suggested.
The discordance between prediabetes diagnoses made by either HbA1c level or impaired fasting glucose in this study was similar to results from the U.S. National Health and Nutrition Examination Survey (NHANES), they added. In the current study, 19.7% met the HbA1c criterion for prediabetes without having impaired fasting glucose, compared with 17% in the NHANES data. In NHANES, the HbA1c test had a 27% sensitivity and a 93% specificity for diagnosing prediabetes, compared with a sensitivity of 21% and a specificity of 91% in the Japanese cohort.
Subjects in the Japanese study ranged in age from 24-82 years, with a mean age of 50 years; 75% were men.
Differences in baseline characteristics made up different cardiovascular risk profiles between individuals diagnosed with prediabetes solely based on HbA1c level or impaired fasting glucose. People diagnosed with prediabetes solely on the HbA1c criterion were more likely to be female and older, and less likely to be hypertensive or obese. They also had lower levels of triglyceride, uric acid, and HDL cholesterol.
The investigators reported having no conflicts of interest. The study was funded in part by Japan’s Ministry of Health, Labor and Welfare.
SAN DIEGO – Having a hemoglobin A1c level of 5.7%-6.4% or impaired fasting glucose each predicted a sixfold higher risk for developing diabetes among individuals screened for the disease, and people who meet both criteria are at a 32-fold increased risk for diabetes, compared with normoglycemic individuals, a large longitudinal study found.
Using the two tests together could better identify people who are most likely to progress to diabetes and who could therefore benefit from early interventions, Yoriko Heianza and her associates reported at the annual scientific sessions of the American Diabetes Association. The findings simultaneously were published online (Lancet 2011 [doi:10.1016/S0140-6736(11)60472-8]).
The study followed 6,241 Japanese subjects, most of whom were government employees and who did not have diabetes at the time of their annual health screenings between 1997 and 2003, and who had annual exams for the next 4-5 years. During that time, 5% developed diabetes, an incidence similar to that in the general Japanese population.
At the baseline exam, 2,092 (34%) were diagnosed with prediabetes. Of those, nearly 20% were diagnosed with prediabetes solely on the basis of an HBA1c level of 5.7%-6.4% and 61% were diagnosed solely based on impaired fasting glucose, defined as a fasting plasma glucose concentration of 5.6-6.9 mmol/L. The remaining nearly 20% met both criteria for prediabetes, reported Ms. Heianza of the University of Tsukuba (Japan) Institute of Clinical Medicine and Toranomon Hospital, Tokyo.
Only half of the people who were diagnosed with prediabetes based on HbA1c level also had impaired fasting glucose, and only 24% of people diagnosed by impaired fasting glucose also met the HbA1c criterion.
Although the HbA1c test identified fewer individuals with prediabetes (822) than did impaired fasting glucose (1,680), the predictive power for progression to diabetes was similar between tests. Once diagnosed with prediabetes with either test, the risk for developing diabetes was six-fold higher than in normoglycemic individuals, after adjusting for the effects of age, sex, and other factors.
Meeting both criteria significantly increased the risk of developing diabetes to a level 32 times higher than in normoglycemic participants. The predictive power of using both tests is multiplied rather than simply additive, the investigators suggested.
The discordance between prediabetes diagnoses made by either HbA1c level or impaired fasting glucose in this study was similar to results from the U.S. National Health and Nutrition Examination Survey (NHANES), they added. In the current study, 19.7% met the HbA1c criterion for prediabetes without having impaired fasting glucose, compared with 17% in the NHANES data. In NHANES, the HbA1c test had a 27% sensitivity and a 93% specificity for diagnosing prediabetes, compared with a sensitivity of 21% and a specificity of 91% in the Japanese cohort.
Subjects in the Japanese study ranged in age from 24-82 years, with a mean age of 50 years; 75% were men.
Differences in baseline characteristics made up different cardiovascular risk profiles between individuals diagnosed with prediabetes solely based on HbA1c level or impaired fasting glucose. People diagnosed with prediabetes solely on the HbA1c criterion were more likely to be female and older, and less likely to be hypertensive or obese. They also had lower levels of triglyceride, uric acid, and HDL cholesterol.
The investigators reported having no conflicts of interest. The study was funded in part by Japan’s Ministry of Health, Labor and Welfare.
FROM THE ANNUAL SCIENTIFIC SESSIONS OF THE AMERICAN DIABETES ASSOCIATION
Major Finding: Having an HbA1c level of 5.7%-6.4% or impaired fasting glucose each predicted a sixfold higher risk for developing diabetes among people screened for the disease, and people who meet both criteria were at a 32-fold increased risk for diabetes, compared with normoglycemic individuals.
Data Source: Longitudinal cohort study in 6,241 Japanese people without diabetes when they presented for routine health checks who were followed for a mean of 5 years.
Disclosures: The investigators reported having no conflicts of interest. The study was funded in part by Japan’s Ministry of Health, Labor and Welfare.
Multifactorial Intervention Did Not Cut Cardiac Events in Type 2 Diabetes
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 A1c 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 HbA1c 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.
Although only a small trend toward cardiovascular benefit from
intensive treatment compared with routine care was recorded, some other
aspects of the trial have important messages.
|
Unforeseen changes to national guidelines during the trial meant that
by the end of ADDITION-Europe, the treatment groups were similar in
terms of allocated treatments such as statins and had similar prevalence
of glycemia and cardiovascular risk factors. As a result, achieving the
target of a 30% reduction in cardiovascular events with intensive
therapy became unlikely.
In addition, event rates were only half
those expected in the initial power calculation. This finding might have
obscured a true benefit as suggested by the divergence in event rates
at 4 years. Moreover, medical practices that were motivated to
participate in ADDITION-Europe might have already improved their quality
of diabetes care.
What ADDITION-Europe could not answer is whether screen detection of diabetes is clinically beneficial against the background of current clinical diagnosis and practice. However, the substantial improvements seen in the routine-care group in blood pressure (from systolic 150 mm Hg at baseline to 138 mm Hg at follow-up) and cholesterol (LDL 3.5-2.3 mmol/L) suggest that early diagnosis and treatment of diabetes according to current guidelines are likely to be beneficial.
Dr. David Preiss and Dr. Naveed Sattar are with the British Heart Foundation, Glasgow Cardiovascular Research Centre, University of Glasgow, Scotland. Dr. Preiss and Dr. Sattar declared that they have no disclosures.
Although only a small trend toward cardiovascular benefit from
intensive treatment compared with routine care was recorded, some other
aspects of the trial have important messages.
|
Unforeseen changes to national guidelines during the trial meant that
by the end of ADDITION-Europe, the treatment groups were similar in
terms of allocated treatments such as statins and had similar prevalence
of glycemia and cardiovascular risk factors. As a result, achieving the
target of a 30% reduction in cardiovascular events with intensive
therapy became unlikely.
In addition, event rates were only half
those expected in the initial power calculation. This finding might have
obscured a true benefit as suggested by the divergence in event rates
at 4 years. Moreover, medical practices that were motivated to
participate in ADDITION-Europe might have already improved their quality
of diabetes care.
What ADDITION-Europe could not answer is whether screen detection of diabetes is clinically beneficial against the background of current clinical diagnosis and practice. However, the substantial improvements seen in the routine-care group in blood pressure (from systolic 150 mm Hg at baseline to 138 mm Hg at follow-up) and cholesterol (LDL 3.5-2.3 mmol/L) suggest that early diagnosis and treatment of diabetes according to current guidelines are likely to be beneficial.
Dr. David Preiss and Dr. Naveed Sattar are with the British Heart Foundation, Glasgow Cardiovascular Research Centre, University of Glasgow, Scotland. Dr. Preiss and Dr. Sattar declared that they have no disclosures.
Although only a small trend toward cardiovascular benefit from
intensive treatment compared with routine care was recorded, some other
aspects of the trial have important messages.
|
Unforeseen changes to national guidelines during the trial meant that
by the end of ADDITION-Europe, the treatment groups were similar in
terms of allocated treatments such as statins and had similar prevalence
of glycemia and cardiovascular risk factors. As a result, achieving the
target of a 30% reduction in cardiovascular events with intensive
therapy became unlikely.
In addition, event rates were only half
those expected in the initial power calculation. This finding might have
obscured a true benefit as suggested by the divergence in event rates
at 4 years. Moreover, medical practices that were motivated to
participate in ADDITION-Europe might have already improved their quality
of diabetes care.
What ADDITION-Europe could not answer is whether screen detection of diabetes is clinically beneficial against the background of current clinical diagnosis and practice. However, the substantial improvements seen in the routine-care group in blood pressure (from systolic 150 mm Hg at baseline to 138 mm Hg at follow-up) and cholesterol (LDL 3.5-2.3 mmol/L) suggest that early diagnosis and treatment of diabetes according to current guidelines are likely to be beneficial.
Dr. David Preiss and Dr. Naveed Sattar are with the British Heart Foundation, Glasgow Cardiovascular Research Centre, University of Glasgow, Scotland. Dr. Preiss and Dr. Sattar declared that they have no disclosures.
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 A1c 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 HbA1c 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 A1c 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 HbA1c 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.
FROM THE ANNUAL SCIENTIFIC SESSIONS OF THE AMERICAN DIABETES ASSOCIATION
Multifactorial Intervention Did Not Cut Cardiac Events in Type 2 Diabetes
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 A1c 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 HbA1c 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.
Although only a small trend toward cardiovascular benefit from
intensive treatment compared with routine care was recorded, some other
aspects of the trial have important messages.
Unforeseen changes to national guidelines during the trial meant that
by the end of ADDITION-Europe, the treatment groups were similar in
terms of allocated treatments such as statins and had similar prevalence
of glycemia and cardiovascular risk factors. As a result, achieving the
target of a 30% reduction in cardiovascular events with intensive
therapy became unlikely.
 Dr. Sattar Naveed |
In addition, event rates were only half
those expected in the initial power calculation. This finding might have
obscured a true benefit as suggested by the divergence in event rates
at 4 years. Moreover, medical practices that were motivated to
participate in ADDITION-Europe might have already improved their quality
of diabetes care.
What ADDITION-Europe could not answer is
whether screen detection of diabetes is clinically beneficial against
the background of current clinical diagnosis and practice. However, the
substantial improvements seen in the routine-care group in blood
pressure (from systolic 150 mm Hg at baseline to 138 mm Hg at follow-up)
and cholesterol (LDL 3.5-2.3 mmol/L) suggest that early diagnosis and
treatment of diabetes according to current guidelines are likely to be
beneficial.
Dr. David Preiss and Dr. Naveed Sattar
are with the British Heart Foundation, Glasgow Cardiovascular Research
Centre, University of Glasgow, Scotland. Dr. Preiss and Dr. Sattar
declared that they have no disclosures.
Although only a small trend toward cardiovascular benefit from
intensive treatment compared with routine care was recorded, some other
aspects of the trial have important messages.
Unforeseen changes to national guidelines during the trial meant that
by the end of ADDITION-Europe, the treatment groups were similar in
terms of allocated treatments such as statins and had similar prevalence
of glycemia and cardiovascular risk factors. As a result, achieving the
target of a 30% reduction in cardiovascular events with intensive
therapy became unlikely.
Dr. Sattar Naveed |
In addition, event rates were only half
those expected in the initial power calculation. This finding might have
obscured a true benefit as suggested by the divergence in event rates
at 4 years. Moreover, medical practices that were motivated to
participate in ADDITION-Europe might have already improved their quality
of diabetes care.
What ADDITION-Europe could not answer is
whether screen detection of diabetes is clinically beneficial against
the background of current clinical diagnosis and practice. However, the
substantial improvements seen in the routine-care group in blood
pressure (from systolic 150 mm Hg at baseline to 138 mm Hg at follow-up)
and cholesterol (LDL 3.5-2.3 mmol/L) suggest that early diagnosis and
treatment of diabetes according to current guidelines are likely to be
beneficial.
Dr. David Preiss and Dr. Naveed Sattar
are with the British Heart Foundation, Glasgow Cardiovascular Research
Centre, University of Glasgow, Scotland. Dr. Preiss and Dr. Sattar
declared that they have no disclosures.
Although only a small trend toward cardiovascular benefit from
intensive treatment compared with routine care was recorded, some other
aspects of the trial have important messages.
Unforeseen changes to national guidelines during the trial meant that
by the end of ADDITION-Europe, the treatment groups were similar in
terms of allocated treatments such as statins and had similar prevalence
of glycemia and cardiovascular risk factors. As a result, achieving the
target of a 30% reduction in cardiovascular events with intensive
therapy became unlikely.
Dr. Sattar Naveed |
In addition, event rates were only half
those expected in the initial power calculation. This finding might have
obscured a true benefit as suggested by the divergence in event rates
at 4 years. Moreover, medical practices that were motivated to
participate in ADDITION-Europe might have already improved their quality
of diabetes care.
What ADDITION-Europe could not answer is
whether screen detection of diabetes is clinically beneficial against
the background of current clinical diagnosis and practice. However, the
substantial improvements seen in the routine-care group in blood
pressure (from systolic 150 mm Hg at baseline to 138 mm Hg at follow-up)
and cholesterol (LDL 3.5-2.3 mmol/L) suggest that early diagnosis and
treatment of diabetes according to current guidelines are likely to be
beneficial.
Dr. David Preiss and Dr. Naveed Sattar
are with the British Heart Foundation, Glasgow Cardiovascular Research
Centre, University of Glasgow, Scotland. Dr. Preiss and Dr. Sattar
declared that they have no disclosures.
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 A1c 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 HbA1c 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 A1c 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 HbA1c 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.
FROM THE ANNUAL SCIENTIFIC SESSIONS OF THE AMERICAN DIABETES ASSOCIATION
Glycemic Control Protects Against Heart Failure in Type 1 Diabetes
SAN DIEGO – Tight control of hemoglobin A1c levels significantly reduces the risk of heart failure in patients with type 1 diabetes, results from a large, long-term study show.
In fact, patients with very poor glycemic control were four times as likely to experience heart failure, compared with their counterparts with optimal glycemic control.
"Because treatment for heart failure improves survival and quality of life, clinicians should be observant of signs of heart failure in management of patients with type 1 diabetes, starting at an early stage," lead author Dr. Marcus Lind wrote in the study, which was presented at the annual scientific sessions of the American Diabetes Association and simultaneously published online in the Lancet on June 25. "Echocardiography might be warranted, especially in the presence of poor glycemic control, long duration of diabetes, or an adverse risk factor profile."
Dr. Lind of the department of medicine at Uddevalla (Sweden) Hospital and his associates used the Swedish national diabetes registry to identify 20,985 patients aged 18 years or older with type 1 disease who had no known heart failure and who were registered between January 1998 and December 2003. They followed the cohort until hospital admission for heart failure, death, or end of follow-up on Dec. 31, 2009 (Lancet 2011 June 25 [doi: 10.1016/S0140-6736(11)60471-6]).
The incidence of heart failure was determined by dividing the number of patient-years of follow-up in a particular HbA1c category, reported as events per 1,000 years of follow-up. The six HbA1c categories were less than 6.5%, from 6.5% to less than 7.5%, from 7.5% to less than 8.5%, from 8.5% to less than 9.5%, from 9.5% to less than 10.5%, and 10.5% or greater. Cox regression analysis was used to study possible associations between heart failure and patients’ characteristics.
The mean age of patients was 39 years, and 45% were female; they had had diabetes for a mean of 14 years, and their mean body mass index was 25 kg/m2. During a median follow-up of 9 years, 635 patients (3%) were admitted with a primary or secondary diagnosis of heart failure, for an incidence of 3.38 per 1,000 patient-years. The incidence of heart failure increased in a stepwise fashion as HbA1c levels increased, from an incidence of 1.42 per 1,000 patient-years among patients in the below-6.5% category of HbA1c to an incidence of 5.20 per 1,000 patient-years among those in the 10.5% or higher category of HbA1c.
After adjustment for age, sex, duration of diabetes, cardiovascular disease risk factors, acute myocardial infarction, and other comorbidities, a Cox regression analysis revealed that patients with an HbA1c level of 10.5% or higher were four times more likely to develop heart failure than were those who had an HbA1c level of less than 6.5%.
Other independent predictors of heart failure included age (hazard ratio, 1.64 per 10-year increase); duration of diabetes (HR, 1.34 per 10-year increase); BMI (HR, 1.05 per 1 kg/m2 increase); systolic blood pressure (HR, 1.15 per 10 mm Hg increase); smoking (HR, 1.11-1.90, according to reported frequency); valve surgery (HR, 2.32); atrial fibrillation (HR 1.89); myocardial infarction (HR, 6.42), and ischemic heart disease (HR, 2.9).
"For many years there have observations that poor glycemic control is linked to heart attack and cardiovascular mortality," Dr. Sue Kirkman, senior vice president of medical affairs and community information for the American Diabetes Association, said in an interview at the meeting. "This may be the first time that it’s been shown to be linked to heart failure in a type 1 population."
She called the study "hypothesis-generating," and noted that a long-term randomized trial will be needed to confirm the findings. "It is interesting, because it seems that in type 1 diabetes there may be a stronger link between glucose lowering and cardiac outcomes than in type 2 diabetes," she said.
The researchers acknowledged certain limitations of the study, including its observational design and the fact that only data on hospital admission for heart failure were available from the Swedish national diabetes registry, "so the true incidence of heart failure could be underestimated," they wrote. "Patients with early signs of heart failure, or asymptomatic heart failure detectable by echocardiography, will not have been captured."
The study was supported by an unrestricted grant from AstraZeneca, Novo Nordisk Scandinavia, the Swedish Heart and Lung Foundation, and the Swedish Research Council. Dr. Lind disclosed that he has received honoraria or served as consultant for Bayer, Eli Lilly, Novartis, Novo Nordisk Scandinavia, Medtronic Pfizer, and Sanofi-Aventis; and has been a member of an advisory board for Novo Nordisk Scandinavia.
How tightly should glycemia be controlled in diabetes? The clear message from Dr. Lind’s and his colleagues’ paper is that tight control of glycemia in type 1 diabetes is essential, especially now that they have shown that such control can prevent heart failure, besides other aspects of cardiovascular disease. In the future, even established type 1 diabetes cardiomyopathy might be rescued by gene-activated prosurvival paths, as shown in a mouse model. Only in developing countries, where tight control is often not feasible, could less-strict control be acceptable for type 1 diabetes.
Lionel H. Opie, M.D., is director of the Hatter Cardiovascular Research Institute at the University of Cape Town (South Africa). This was adapted from an accompanying commentary published online (Lancet 2011 June 25 [doi: 10.1016/S0140-6736(11)6078703]). He reported no conflicts of interest.
How tightly should glycemia be controlled in diabetes? The clear message from Dr. Lind’s and his colleagues’ paper is that tight control of glycemia in type 1 diabetes is essential, especially now that they have shown that such control can prevent heart failure, besides other aspects of cardiovascular disease. In the future, even established type 1 diabetes cardiomyopathy might be rescued by gene-activated prosurvival paths, as shown in a mouse model. Only in developing countries, where tight control is often not feasible, could less-strict control be acceptable for type 1 diabetes.
Lionel H. Opie, M.D., is director of the Hatter Cardiovascular Research Institute at the University of Cape Town (South Africa). This was adapted from an accompanying commentary published online (Lancet 2011 June 25 [doi: 10.1016/S0140-6736(11)6078703]). He reported no conflicts of interest.
How tightly should glycemia be controlled in diabetes? The clear message from Dr. Lind’s and his colleagues’ paper is that tight control of glycemia in type 1 diabetes is essential, especially now that they have shown that such control can prevent heart failure, besides other aspects of cardiovascular disease. In the future, even established type 1 diabetes cardiomyopathy might be rescued by gene-activated prosurvival paths, as shown in a mouse model. Only in developing countries, where tight control is often not feasible, could less-strict control be acceptable for type 1 diabetes.
Lionel H. Opie, M.D., is director of the Hatter Cardiovascular Research Institute at the University of Cape Town (South Africa). This was adapted from an accompanying commentary published online (Lancet 2011 June 25 [doi: 10.1016/S0140-6736(11)6078703]). He reported no conflicts of interest.
SAN DIEGO – Tight control of hemoglobin A1c levels significantly reduces the risk of heart failure in patients with type 1 diabetes, results from a large, long-term study show.
In fact, patients with very poor glycemic control were four times as likely to experience heart failure, compared with their counterparts with optimal glycemic control.
"Because treatment for heart failure improves survival and quality of life, clinicians should be observant of signs of heart failure in management of patients with type 1 diabetes, starting at an early stage," lead author Dr. Marcus Lind wrote in the study, which was presented at the annual scientific sessions of the American Diabetes Association and simultaneously published online in the Lancet on June 25. "Echocardiography might be warranted, especially in the presence of poor glycemic control, long duration of diabetes, or an adverse risk factor profile."
Dr. Lind of the department of medicine at Uddevalla (Sweden) Hospital and his associates used the Swedish national diabetes registry to identify 20,985 patients aged 18 years or older with type 1 disease who had no known heart failure and who were registered between January 1998 and December 2003. They followed the cohort until hospital admission for heart failure, death, or end of follow-up on Dec. 31, 2009 (Lancet 2011 June 25 [doi: 10.1016/S0140-6736(11)60471-6]).
The incidence of heart failure was determined by dividing the number of patient-years of follow-up in a particular HbA1c category, reported as events per 1,000 years of follow-up. The six HbA1c categories were less than 6.5%, from 6.5% to less than 7.5%, from 7.5% to less than 8.5%, from 8.5% to less than 9.5%, from 9.5% to less than 10.5%, and 10.5% or greater. Cox regression analysis was used to study possible associations between heart failure and patients’ characteristics.
The mean age of patients was 39 years, and 45% were female; they had had diabetes for a mean of 14 years, and their mean body mass index was 25 kg/m2. During a median follow-up of 9 years, 635 patients (3%) were admitted with a primary or secondary diagnosis of heart failure, for an incidence of 3.38 per 1,000 patient-years. The incidence of heart failure increased in a stepwise fashion as HbA1c levels increased, from an incidence of 1.42 per 1,000 patient-years among patients in the below-6.5% category of HbA1c to an incidence of 5.20 per 1,000 patient-years among those in the 10.5% or higher category of HbA1c.
After adjustment for age, sex, duration of diabetes, cardiovascular disease risk factors, acute myocardial infarction, and other comorbidities, a Cox regression analysis revealed that patients with an HbA1c level of 10.5% or higher were four times more likely to develop heart failure than were those who had an HbA1c level of less than 6.5%.
Other independent predictors of heart failure included age (hazard ratio, 1.64 per 10-year increase); duration of diabetes (HR, 1.34 per 10-year increase); BMI (HR, 1.05 per 1 kg/m2 increase); systolic blood pressure (HR, 1.15 per 10 mm Hg increase); smoking (HR, 1.11-1.90, according to reported frequency); valve surgery (HR, 2.32); atrial fibrillation (HR 1.89); myocardial infarction (HR, 6.42), and ischemic heart disease (HR, 2.9).
"For many years there have observations that poor glycemic control is linked to heart attack and cardiovascular mortality," Dr. Sue Kirkman, senior vice president of medical affairs and community information for the American Diabetes Association, said in an interview at the meeting. "This may be the first time that it’s been shown to be linked to heart failure in a type 1 population."
She called the study "hypothesis-generating," and noted that a long-term randomized trial will be needed to confirm the findings. "It is interesting, because it seems that in type 1 diabetes there may be a stronger link between glucose lowering and cardiac outcomes than in type 2 diabetes," she said.
The researchers acknowledged certain limitations of the study, including its observational design and the fact that only data on hospital admission for heart failure were available from the Swedish national diabetes registry, "so the true incidence of heart failure could be underestimated," they wrote. "Patients with early signs of heart failure, or asymptomatic heart failure detectable by echocardiography, will not have been captured."
The study was supported by an unrestricted grant from AstraZeneca, Novo Nordisk Scandinavia, the Swedish Heart and Lung Foundation, and the Swedish Research Council. Dr. Lind disclosed that he has received honoraria or served as consultant for Bayer, Eli Lilly, Novartis, Novo Nordisk Scandinavia, Medtronic Pfizer, and Sanofi-Aventis; and has been a member of an advisory board for Novo Nordisk Scandinavia.
SAN DIEGO – Tight control of hemoglobin A1c levels significantly reduces the risk of heart failure in patients with type 1 diabetes, results from a large, long-term study show.
In fact, patients with very poor glycemic control were four times as likely to experience heart failure, compared with their counterparts with optimal glycemic control.
"Because treatment for heart failure improves survival and quality of life, clinicians should be observant of signs of heart failure in management of patients with type 1 diabetes, starting at an early stage," lead author Dr. Marcus Lind wrote in the study, which was presented at the annual scientific sessions of the American Diabetes Association and simultaneously published online in the Lancet on June 25. "Echocardiography might be warranted, especially in the presence of poor glycemic control, long duration of diabetes, or an adverse risk factor profile."
Dr. Lind of the department of medicine at Uddevalla (Sweden) Hospital and his associates used the Swedish national diabetes registry to identify 20,985 patients aged 18 years or older with type 1 disease who had no known heart failure and who were registered between January 1998 and December 2003. They followed the cohort until hospital admission for heart failure, death, or end of follow-up on Dec. 31, 2009 (Lancet 2011 June 25 [doi: 10.1016/S0140-6736(11)60471-6]).
The incidence of heart failure was determined by dividing the number of patient-years of follow-up in a particular HbA1c category, reported as events per 1,000 years of follow-up. The six HbA1c categories were less than 6.5%, from 6.5% to less than 7.5%, from 7.5% to less than 8.5%, from 8.5% to less than 9.5%, from 9.5% to less than 10.5%, and 10.5% or greater. Cox regression analysis was used to study possible associations between heart failure and patients’ characteristics.
The mean age of patients was 39 years, and 45% were female; they had had diabetes for a mean of 14 years, and their mean body mass index was 25 kg/m2. During a median follow-up of 9 years, 635 patients (3%) were admitted with a primary or secondary diagnosis of heart failure, for an incidence of 3.38 per 1,000 patient-years. The incidence of heart failure increased in a stepwise fashion as HbA1c levels increased, from an incidence of 1.42 per 1,000 patient-years among patients in the below-6.5% category of HbA1c to an incidence of 5.20 per 1,000 patient-years among those in the 10.5% or higher category of HbA1c.
After adjustment for age, sex, duration of diabetes, cardiovascular disease risk factors, acute myocardial infarction, and other comorbidities, a Cox regression analysis revealed that patients with an HbA1c level of 10.5% or higher were four times more likely to develop heart failure than were those who had an HbA1c level of less than 6.5%.
Other independent predictors of heart failure included age (hazard ratio, 1.64 per 10-year increase); duration of diabetes (HR, 1.34 per 10-year increase); BMI (HR, 1.05 per 1 kg/m2 increase); systolic blood pressure (HR, 1.15 per 10 mm Hg increase); smoking (HR, 1.11-1.90, according to reported frequency); valve surgery (HR, 2.32); atrial fibrillation (HR 1.89); myocardial infarction (HR, 6.42), and ischemic heart disease (HR, 2.9).
"For many years there have observations that poor glycemic control is linked to heart attack and cardiovascular mortality," Dr. Sue Kirkman, senior vice president of medical affairs and community information for the American Diabetes Association, said in an interview at the meeting. "This may be the first time that it’s been shown to be linked to heart failure in a type 1 population."
She called the study "hypothesis-generating," and noted that a long-term randomized trial will be needed to confirm the findings. "It is interesting, because it seems that in type 1 diabetes there may be a stronger link between glucose lowering and cardiac outcomes than in type 2 diabetes," she said.
The researchers acknowledged certain limitations of the study, including its observational design and the fact that only data on hospital admission for heart failure were available from the Swedish national diabetes registry, "so the true incidence of heart failure could be underestimated," they wrote. "Patients with early signs of heart failure, or asymptomatic heart failure detectable by echocardiography, will not have been captured."
The study was supported by an unrestricted grant from AstraZeneca, Novo Nordisk Scandinavia, the Swedish Heart and Lung Foundation, and the Swedish Research Council. Dr. Lind disclosed that he has received honoraria or served as consultant for Bayer, Eli Lilly, Novartis, Novo Nordisk Scandinavia, Medtronic Pfizer, and Sanofi-Aventis; and has been a member of an advisory board for Novo Nordisk Scandinavia.
FROM THE ANNUAL SCIENTIFIC SESSIONS OF THE AMERICAN DIABETES ASSOCIATION
Major Finding: The incidence of heart failure among patients with type 1 diabetes increased in a stepwise fashion as HbA1c levels increased, from 1.42 per 1,000 patient-years in patients with HbA1c below 6.5% to 5.20 per 1,000 patient-years in those in with HbA1c of at least 10.5%.
Data Source: An analysis of 20,985 patients from the Swedish national diabetes registry who were aged 18 years or older, had type 1 disease, no known heart failure, and who were registered during 1998-2003, and followed through 2009.
Disclosures: The study was supported by an unrestricted grant from AstraZeneca, Novo Nordisk Scandinavia, the Swedish Heart and Lung Foundation, and the Swedish Research Council. Dr. Lind disclosed that he has received honoraria or served as consultant for Bayer, Eli Lilly, Novartis, Novo Nordisk Scandinavia, Medtronic Pfizer, and Sanofi-Aventis; and has been a member of an advisory board for Novo Nordisk Scandinavia.
Glycemic Control Protects Against Heart Failure in Type 1 Diabetes
SAN DIEGO – Tight control of hemoglobin A1c levels significantly reduces the risk of heart failure in patients with type 1 diabetes, results from a large, long-term study show.
In fact, patients with very poor glycemic control were four times as likely to experience heart failure, compared with their counterparts with optimal glycemic control.
"Because treatment for heart failure improves survival and quality of life, clinicians should be observant of signs of heart failure in management of patients with type 1 diabetes, starting at an early stage," lead author Dr. Marcus Lind wrote in the study, which was presented at the annual scientific sessions of the American Diabetes Association and simultaneously published online in the Lancet on June 25. "Echocardiography might be warranted, especially in the presence of poor glycemic control, long duration of diabetes, or an adverse risk factor profile."
Dr. Lind of the department of medicine at Uddevalla (Sweden) Hospital and his associates used the Swedish national diabetes registry to identify 20,985 patients aged 18 years or older with type 1 disease who had no known heart failure and who were registered between January 1998 and December 2003. They followed the cohort until hospital admission for heart failure, death, or end of follow-up on Dec. 31, 2009 (Lancet 2011 June 25 [doi: 10.1016/S0140-6736(11)60471-6]).
The incidence of heart failure was determined by dividing the number of patient-years of follow-up in a particular HbA1c category, reported as events per 1,000 years of follow-up. The six HbA1c categories were less than 6.5%, from 6.5% to less than 7.5%, from 7.5% to less than 8.5%, from 8.5% to less than 9.5%, from 9.5% to less than 10.5%, and 10.5% or greater. Cox regression analysis was used to study possible associations between heart failure and patients’ characteristics.
The mean age of patients was 39 years, and 45% were female; they had had diabetes for a mean of 14 years, and their mean body mass index was 25 kg/m2. During a median follow-up of 9 years, 635 patients (3%) were admitted with a primary or secondary diagnosis of heart failure, for an incidence of 3.38 per 1,000 patient-years. The incidence of heart failure increased in a stepwise fashion as HbA1c levels increased, from an incidence of 1.42 per 1,000 patient-years among patients in the below-6.5% category of HbA1c to an incidence of 5.20 per 1,000 patient-years among those in the 10.5% or higher category of HbA1c.
After adjustment for age, sex, duration of diabetes, cardiovascular disease risk factors, acute myocardial infarction, and other comorbidities, a Cox regression analysis revealed that patients with an HbA1c level of 10.5% or higher were four times more likely to develop heart failure than were those who had an HbA1c level of less than 6.5%.
Other independent predictors of heart failure included age (hazard ratio, 1.64 per 10-year increase); duration of diabetes (HR, 1.34 per 10-year increase); BMI (HR, 1.05 per 1 kg/m2 increase); systolic blood pressure (HR, 1.15 per 10 mm Hg increase); smoking (HR, 1.11-1.90, according to reported frequency); valve surgery (HR, 2.32); atrial fibrillation (HR 1.89); myocardial infarction (HR, 6.42), and ischemic heart disease (HR, 2.9).
"For many years there have observations that poor glycemic control is linked to heart attack and cardiovascular mortality," Dr. Sue Kirkman, senior vice president of medical affairs and community information for the American Diabetes Association, said in an interview at the meeting. "This may be the first time that it’s been shown to be linked to heart failure in a type 1 population."
She called the study "hypothesis-generating," and noted that a long-term randomized trial will be needed to confirm the findings. "It is interesting, because it seems that in type 1 diabetes there may be a stronger link between glucose lowering and cardiac outcomes than in type 2 diabetes," she said.
The researchers acknowledged certain limitations of the study, including its observational design and the fact that only data on hospital admission for heart failure were available from the Swedish national diabetes registry, "so the true incidence of heart failure could be underestimated," they wrote. "Patients with early signs of heart failure, or asymptomatic heart failure detectable by echocardiography, will not have been captured."
The study was supported by an unrestricted grant from AstraZeneca, Novo Nordisk Scandinavia, the Swedish Heart and Lung Foundation, and the Swedish Research Council. Dr. Lind disclosed that he has received honoraria or served as consultant for Bayer, Eli Lilly, Novartis, Novo Nordisk Scandinavia, Medtronic Pfizer, and Sanofi-Aventis; and has been a member of an advisory board for Novo Nordisk Scandinavia.
How tightly should glycemia be controlled in diabetes? The clear message from Dr. Lind’s and his colleagues’ paper is that tight control of glycemia in type 1 diabetes is essential, especially now that they have shown that such control can prevent heart failure, besides other aspects of cardiovascular disease. In the future, even established type 1 diabetes cardiomyopathy might be rescued by gene-activated prosurvival paths, as shown in a mouse model. Only in developing countries, where tight control is often not feasible, could less-strict control be acceptable for type 1 diabetes.
Lionel H. Opie, M.D., is director of the Hatter Cardiovascular Research Institute at the University of Cape Town (South Africa). This was adapted from an accompanying commentary published online (Lancet 2011 June 25 [doi: 10.1016/S0140-6736(11)6078703]). He reported no conflicts of interest.
How tightly should glycemia be controlled in diabetes? The clear message from Dr. Lind’s and his colleagues’ paper is that tight control of glycemia in type 1 diabetes is essential, especially now that they have shown that such control can prevent heart failure, besides other aspects of cardiovascular disease. In the future, even established type 1 diabetes cardiomyopathy might be rescued by gene-activated prosurvival paths, as shown in a mouse model. Only in developing countries, where tight control is often not feasible, could less-strict control be acceptable for type 1 diabetes.
Lionel H. Opie, M.D., is director of the Hatter Cardiovascular Research Institute at the University of Cape Town (South Africa). This was adapted from an accompanying commentary published online (Lancet 2011 June 25 [doi: 10.1016/S0140-6736(11)6078703]). He reported no conflicts of interest.
How tightly should glycemia be controlled in diabetes? The clear message from Dr. Lind’s and his colleagues’ paper is that tight control of glycemia in type 1 diabetes is essential, especially now that they have shown that such control can prevent heart failure, besides other aspects of cardiovascular disease. In the future, even established type 1 diabetes cardiomyopathy might be rescued by gene-activated prosurvival paths, as shown in a mouse model. Only in developing countries, where tight control is often not feasible, could less-strict control be acceptable for type 1 diabetes.
Lionel H. Opie, M.D., is director of the Hatter Cardiovascular Research Institute at the University of Cape Town (South Africa). This was adapted from an accompanying commentary published online (Lancet 2011 June 25 [doi: 10.1016/S0140-6736(11)6078703]). He reported no conflicts of interest.
SAN DIEGO – Tight control of hemoglobin A1c levels significantly reduces the risk of heart failure in patients with type 1 diabetes, results from a large, long-term study show.
In fact, patients with very poor glycemic control were four times as likely to experience heart failure, compared with their counterparts with optimal glycemic control.
"Because treatment for heart failure improves survival and quality of life, clinicians should be observant of signs of heart failure in management of patients with type 1 diabetes, starting at an early stage," lead author Dr. Marcus Lind wrote in the study, which was presented at the annual scientific sessions of the American Diabetes Association and simultaneously published online in the Lancet on June 25. "Echocardiography might be warranted, especially in the presence of poor glycemic control, long duration of diabetes, or an adverse risk factor profile."
Dr. Lind of the department of medicine at Uddevalla (Sweden) Hospital and his associates used the Swedish national diabetes registry to identify 20,985 patients aged 18 years or older with type 1 disease who had no known heart failure and who were registered between January 1998 and December 2003. They followed the cohort until hospital admission for heart failure, death, or end of follow-up on Dec. 31, 2009 (Lancet 2011 June 25 [doi: 10.1016/S0140-6736(11)60471-6]).
The incidence of heart failure was determined by dividing the number of patient-years of follow-up in a particular HbA1c category, reported as events per 1,000 years of follow-up. The six HbA1c categories were less than 6.5%, from 6.5% to less than 7.5%, from 7.5% to less than 8.5%, from 8.5% to less than 9.5%, from 9.5% to less than 10.5%, and 10.5% or greater. Cox regression analysis was used to study possible associations between heart failure and patients’ characteristics.
The mean age of patients was 39 years, and 45% were female; they had had diabetes for a mean of 14 years, and their mean body mass index was 25 kg/m2. During a median follow-up of 9 years, 635 patients (3%) were admitted with a primary or secondary diagnosis of heart failure, for an incidence of 3.38 per 1,000 patient-years. The incidence of heart failure increased in a stepwise fashion as HbA1c levels increased, from an incidence of 1.42 per 1,000 patient-years among patients in the below-6.5% category of HbA1c to an incidence of 5.20 per 1,000 patient-years among those in the 10.5% or higher category of HbA1c.
After adjustment for age, sex, duration of diabetes, cardiovascular disease risk factors, acute myocardial infarction, and other comorbidities, a Cox regression analysis revealed that patients with an HbA1c level of 10.5% or higher were four times more likely to develop heart failure than were those who had an HbA1c level of less than 6.5%.
Other independent predictors of heart failure included age (hazard ratio, 1.64 per 10-year increase); duration of diabetes (HR, 1.34 per 10-year increase); BMI (HR, 1.05 per 1 kg/m2 increase); systolic blood pressure (HR, 1.15 per 10 mm Hg increase); smoking (HR, 1.11-1.90, according to reported frequency); valve surgery (HR, 2.32); atrial fibrillation (HR 1.89); myocardial infarction (HR, 6.42), and ischemic heart disease (HR, 2.9).
"For many years there have observations that poor glycemic control is linked to heart attack and cardiovascular mortality," Dr. Sue Kirkman, senior vice president of medical affairs and community information for the American Diabetes Association, said in an interview at the meeting. "This may be the first time that it’s been shown to be linked to heart failure in a type 1 population."
She called the study "hypothesis-generating," and noted that a long-term randomized trial will be needed to confirm the findings. "It is interesting, because it seems that in type 1 diabetes there may be a stronger link between glucose lowering and cardiac outcomes than in type 2 diabetes," she said.
The researchers acknowledged certain limitations of the study, including its observational design and the fact that only data on hospital admission for heart failure were available from the Swedish national diabetes registry, "so the true incidence of heart failure could be underestimated," they wrote. "Patients with early signs of heart failure, or asymptomatic heart failure detectable by echocardiography, will not have been captured."
The study was supported by an unrestricted grant from AstraZeneca, Novo Nordisk Scandinavia, the Swedish Heart and Lung Foundation, and the Swedish Research Council. Dr. Lind disclosed that he has received honoraria or served as consultant for Bayer, Eli Lilly, Novartis, Novo Nordisk Scandinavia, Medtronic Pfizer, and Sanofi-Aventis; and has been a member of an advisory board for Novo Nordisk Scandinavia.
SAN DIEGO – Tight control of hemoglobin A1c levels significantly reduces the risk of heart failure in patients with type 1 diabetes, results from a large, long-term study show.
In fact, patients with very poor glycemic control were four times as likely to experience heart failure, compared with their counterparts with optimal glycemic control.
"Because treatment for heart failure improves survival and quality of life, clinicians should be observant of signs of heart failure in management of patients with type 1 diabetes, starting at an early stage," lead author Dr. Marcus Lind wrote in the study, which was presented at the annual scientific sessions of the American Diabetes Association and simultaneously published online in the Lancet on June 25. "Echocardiography might be warranted, especially in the presence of poor glycemic control, long duration of diabetes, or an adverse risk factor profile."
Dr. Lind of the department of medicine at Uddevalla (Sweden) Hospital and his associates used the Swedish national diabetes registry to identify 20,985 patients aged 18 years or older with type 1 disease who had no known heart failure and who were registered between January 1998 and December 2003. They followed the cohort until hospital admission for heart failure, death, or end of follow-up on Dec. 31, 2009 (Lancet 2011 June 25 [doi: 10.1016/S0140-6736(11)60471-6]).
The incidence of heart failure was determined by dividing the number of patient-years of follow-up in a particular HbA1c category, reported as events per 1,000 years of follow-up. The six HbA1c categories were less than 6.5%, from 6.5% to less than 7.5%, from 7.5% to less than 8.5%, from 8.5% to less than 9.5%, from 9.5% to less than 10.5%, and 10.5% or greater. Cox regression analysis was used to study possible associations between heart failure and patients’ characteristics.
The mean age of patients was 39 years, and 45% were female; they had had diabetes for a mean of 14 years, and their mean body mass index was 25 kg/m2. During a median follow-up of 9 years, 635 patients (3%) were admitted with a primary or secondary diagnosis of heart failure, for an incidence of 3.38 per 1,000 patient-years. The incidence of heart failure increased in a stepwise fashion as HbA1c levels increased, from an incidence of 1.42 per 1,000 patient-years among patients in the below-6.5% category of HbA1c to an incidence of 5.20 per 1,000 patient-years among those in the 10.5% or higher category of HbA1c.
After adjustment for age, sex, duration of diabetes, cardiovascular disease risk factors, acute myocardial infarction, and other comorbidities, a Cox regression analysis revealed that patients with an HbA1c level of 10.5% or higher were four times more likely to develop heart failure than were those who had an HbA1c level of less than 6.5%.
Other independent predictors of heart failure included age (hazard ratio, 1.64 per 10-year increase); duration of diabetes (HR, 1.34 per 10-year increase); BMI (HR, 1.05 per 1 kg/m2 increase); systolic blood pressure (HR, 1.15 per 10 mm Hg increase); smoking (HR, 1.11-1.90, according to reported frequency); valve surgery (HR, 2.32); atrial fibrillation (HR 1.89); myocardial infarction (HR, 6.42), and ischemic heart disease (HR, 2.9).
"For many years there have observations that poor glycemic control is linked to heart attack and cardiovascular mortality," Dr. Sue Kirkman, senior vice president of medical affairs and community information for the American Diabetes Association, said in an interview at the meeting. "This may be the first time that it’s been shown to be linked to heart failure in a type 1 population."
She called the study "hypothesis-generating," and noted that a long-term randomized trial will be needed to confirm the findings. "It is interesting, because it seems that in type 1 diabetes there may be a stronger link between glucose lowering and cardiac outcomes than in type 2 diabetes," she said.
The researchers acknowledged certain limitations of the study, including its observational design and the fact that only data on hospital admission for heart failure were available from the Swedish national diabetes registry, "so the true incidence of heart failure could be underestimated," they wrote. "Patients with early signs of heart failure, or asymptomatic heart failure detectable by echocardiography, will not have been captured."
The study was supported by an unrestricted grant from AstraZeneca, Novo Nordisk Scandinavia, the Swedish Heart and Lung Foundation, and the Swedish Research Council. Dr. Lind disclosed that he has received honoraria or served as consultant for Bayer, Eli Lilly, Novartis, Novo Nordisk Scandinavia, Medtronic Pfizer, and Sanofi-Aventis; and has been a member of an advisory board for Novo Nordisk Scandinavia.
FROM THE ANNUAL SCIENTIFIC SESSIONS OF THE AMERICAN DIABETES ASSOCIATION
Major Finding: The incidence of heart failure among patients with type 1 diabetes increased in a stepwise fashion as HbA1c levels increased, from 1.42 per 1,000 patient-years in patients with HbA1c below 6.5% to 5.20 per 1,000 patient-years in those in with HbA1c of at least 10.5%.
Data Source: An analysis of 20,985 patients from the Swedish national diabetes registry who were aged 18 years or older, had type 1 disease, no known heart failure, and who were registered during 1998-2003, and followed through 2009.
Disclosures: The study was supported by an unrestricted grant from AstraZeneca, Novo Nordisk Scandinavia, the Swedish Heart and Lung Foundation, and the Swedish Research Council. Dr. Lind disclosed that he has received honoraria or served as consultant for Bayer, Eli Lilly, Novartis, Novo Nordisk Scandinavia, Medtronic Pfizer, and Sanofi-Aventis; and has been a member of an advisory board for Novo Nordisk Scandinavia.