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The 2016 updates of the American Diabetes Association’s Standards of Medical Care in Diabetes bring an enhanced focus on patient-centered care, evidence-based updates for atherosclerotic cardiovascular disease, and a dedicated section on obesity (Diabetes Care 2016;39[Suppl. 1]:S4-S5. doi: 10.2337/dc16-S003).

According to Dr. Robert E. Ratner, chief scientific and medical officer for the American Diabetes Association in Alexandria, Va., the focus of care for individuals with diabetes is to achieve a holistic approach coordinating patient-centered disease management to maximize the benefits of an integrated team approach. The 2016 guideline puts that mission front and center.

When formulating its yearly updates, the ADA looks for new information “that makes a significant change in the practice of medicine” and that will affect patient care, Dr. Ratner said in an interview. “We are trying to make the recommendations both thorough and evidence based.”

The guidelines were formulated by a professional practice committee chaired by Dr. William H. Herman, professor of epidemiology and internal medicine at the University of Michigan, Ann Arbor. According to the guidelines, the appointed committee “adheres to the Institute of Medicine Standards for Developing Trustworthy Clinical Practice Guidelines,” and the draft guidelines were made publicly available for comment before publication.

What’s different for 2016? Foremost is a change in approach, to more patient-centered care. Guidelines always address best practices at the population health level, Dr. Ratner said. However, “for each individual patient, interventions must be tailored, and the intervention must be adjusted to meet individual needs.”

One example is a relaxation in hemoglobin A_1c (HbA_1c) targets for the infirm and the elderly, based on data from large Veterans Affairs studies and from the National Health and Nutrition Examination Survey that show the harms of inappropriately low HbA_1c levels for fragile populations. The updated guidelines encourage those caring for these patients to “back off and be more patient centered,” said Dr. Ratner.

The practice guidelines also acknowledge new information regarding the risk of euglycemic diabetic ketoacidosis with the use of sodium-glucose cotransporter 2 (SGLT2) inhibitors.

These changes strive to take into account new research, while acknowledging that in some areas there’s still a paucity of data, said Dr. Ratner. For example, recommendations regarding use of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors for certain individuals with dyslipidemia and diabetes are included, though study of this new class of medications is ongoing; the guideline includes an evidence rating system to allow practitioners to rate the strength of recommendations when making individualized treatment decisions.

The guideline also gives the option of adding ezetimibe to a moderate statin dose for some individuals with diabetes and dyslipidemia, acknowledging the findings of the IMPROVE-IT trial. Other atherosclerotic cardiovascular disease updates include considering aspirin therapy for women 50 years and older who have diabetes with at least one additional major risk factor.

A new section devoted to obesity management acknowledges its critical importance in type 2 diabetes mellitus (T2DM). While continuing to emphasize the importance of lifestyle changes, such as healthful eating and physical activity, the guideline acknowledges that there’s a role for pharmacotherapy and surgical treatment. In addition to providing information on approved anti-obesity medication, the guideline addresses the benefit of bariatric surgery for a select group of patients. “We can’t ignore the data” that point toward a role for these interventions for some patients, said Dr. Ratner. The guideline weighs the advantages and disadvantages of each approach.

Other updates include a recommendation for testing all adults for diabetes beginning at age 45 years, without regard to weight; clarifying testing guidelines to emphasize that no one testing strategy is preferred over another; slightly relaxing HbA_1c targets for pregnant women to 6%-6.5%; and enhancing guidelines for hospitalized patients with diabetes.

The complete practice guideline, which runs to 119 pages, is accompanied by an abridged version that provides a basic framework for diabetes management. Dr. Ratner said that the complete standards of care are appropriate for endocrinologists and others who focus on diabetes management, while the abridged version is a resource for primary care providers who may see some patients with diabetes in the mix of their caseload. Both documents are available to view or download free of charge. A summary of key updates precedes the full text of the guidelines, so that those using last year’s guidelines can familiarize themselves quickly with changes in the new version.

Dr. Herman reported chairing data and safety monitoring boards for Merck Sharp & Dohme, and Lexicon Pharmaceuticals. He has served as the editor for the Americas of Diabetic Medicine, and as ad hoc editor in chief of Diabetes Care.

[email protected]

On Twitter @karioakes

The 2016 updates of the American Diabetes Association’s Standards of Medical Care in Diabetes bring an enhanced focus on patient-centered care, evidence-based updates for atherosclerotic cardiovascular disease, and a dedicated section on obesity (Diabetes Care 2016;39[Suppl. 1]:S4-S5. doi: 10.2337/dc16-S003).

According to Dr. Robert E. Ratner, chief scientific and medical officer for the American Diabetes Association in Alexandria, Va., the focus of care for individuals with diabetes is to achieve a holistic approach coordinating patient-centered disease management to maximize the benefits of an integrated team approach. The 2016 guideline puts that mission front and center.

When formulating its yearly updates, the ADA looks for new information “that makes a significant change in the practice of medicine” and that will affect patient care, Dr. Ratner said in an interview. “We are trying to make the recommendations both thorough and evidence based.”

The guidelines were formulated by a professional practice committee chaired by Dr. William H. Herman, professor of epidemiology and internal medicine at the University of Michigan, Ann Arbor. According to the guidelines, the appointed committee “adheres to the Institute of Medicine Standards for Developing Trustworthy Clinical Practice Guidelines,” and the draft guidelines were made publicly available for comment before publication.

What’s different for 2016? Foremost is a change in approach, to more patient-centered care. Guidelines always address best practices at the population health level, Dr. Ratner said. However, “for each individual patient, interventions must be tailored, and the intervention must be adjusted to meet individual needs.”

One example is a relaxation in hemoglobin A_1c (HbA_1c) targets for the infirm and the elderly, based on data from large Veterans Affairs studies and from the National Health and Nutrition Examination Survey that show the harms of inappropriately low HbA_1c levels for fragile populations. The updated guidelines encourage those caring for these patients to “back off and be more patient centered,” said Dr. Ratner.

The practice guidelines also acknowledge new information regarding the risk of euglycemic diabetic ketoacidosis with the use of sodium-glucose cotransporter 2 (SGLT2) inhibitors.

These changes strive to take into account new research, while acknowledging that in some areas there’s still a paucity of data, said Dr. Ratner. For example, recommendations regarding use of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors for certain individuals with dyslipidemia and diabetes are included, though study of this new class of medications is ongoing; the guideline includes an evidence rating system to allow practitioners to rate the strength of recommendations when making individualized treatment decisions.

The guideline also gives the option of adding ezetimibe to a moderate statin dose for some individuals with diabetes and dyslipidemia, acknowledging the findings of the IMPROVE-IT trial. Other atherosclerotic cardiovascular disease updates include considering aspirin therapy for women 50 years and older who have diabetes with at least one additional major risk factor.

A new section devoted to obesity management acknowledges its critical importance in type 2 diabetes mellitus (T2DM). While continuing to emphasize the importance of lifestyle changes, such as healthful eating and physical activity, the guideline acknowledges that there’s a role for pharmacotherapy and surgical treatment. In addition to providing information on approved anti-obesity medication, the guideline addresses the benefit of bariatric surgery for a select group of patients. “We can’t ignore the data” that point toward a role for these interventions for some patients, said Dr. Ratner. The guideline weighs the advantages and disadvantages of each approach.

Other updates include a recommendation for testing all adults for diabetes beginning at age 45 years, without regard to weight; clarifying testing guidelines to emphasize that no one testing strategy is preferred over another; slightly relaxing HbA_1c targets for pregnant women to 6%-6.5%; and enhancing guidelines for hospitalized patients with diabetes.

The complete practice guideline, which runs to 119 pages, is accompanied by an abridged version that provides a basic framework for diabetes management. Dr. Ratner said that the complete standards of care are appropriate for endocrinologists and others who focus on diabetes management, while the abridged version is a resource for primary care providers who may see some patients with diabetes in the mix of their caseload. Both documents are available to view or download free of charge. A summary of key updates precedes the full text of the guidelines, so that those using last year’s guidelines can familiarize themselves quickly with changes in the new version.

Dr. Herman reported chairing data and safety monitoring boards for Merck Sharp & Dohme, and Lexicon Pharmaceuticals. He has served as the editor for the Americas of Diabetic Medicine, and as ad hoc editor in chief of Diabetes Care.

[email protected]

On Twitter @karioakes

The 2016 updates of the American Diabetes Association’s Standards of Medical Care in Diabetes bring an enhanced focus on patient-centered care, evidence-based updates for atherosclerotic cardiovascular disease, and a dedicated section on obesity (Diabetes Care 2016;39[Suppl. 1]:S4-S5. doi: 10.2337/dc16-S003).

According to Dr. Robert E. Ratner, chief scientific and medical officer for the American Diabetes Association in Alexandria, Va., the focus of care for individuals with diabetes is to achieve a holistic approach coordinating patient-centered disease management to maximize the benefits of an integrated team approach. The 2016 guideline puts that mission front and center.

When formulating its yearly updates, the ADA looks for new information “that makes a significant change in the practice of medicine” and that will affect patient care, Dr. Ratner said in an interview. “We are trying to make the recommendations both thorough and evidence based.”

The guidelines were formulated by a professional practice committee chaired by Dr. William H. Herman, professor of epidemiology and internal medicine at the University of Michigan, Ann Arbor. According to the guidelines, the appointed committee “adheres to the Institute of Medicine Standards for Developing Trustworthy Clinical Practice Guidelines,” and the draft guidelines were made publicly available for comment before publication.

What’s different for 2016? Foremost is a change in approach, to more patient-centered care. Guidelines always address best practices at the population health level, Dr. Ratner said. However, “for each individual patient, interventions must be tailored, and the intervention must be adjusted to meet individual needs.”

One example is a relaxation in hemoglobin A_1c (HbA_1c) targets for the infirm and the elderly, based on data from large Veterans Affairs studies and from the National Health and Nutrition Examination Survey that show the harms of inappropriately low HbA_1c levels for fragile populations. The updated guidelines encourage those caring for these patients to “back off and be more patient centered,” said Dr. Ratner.

The practice guidelines also acknowledge new information regarding the risk of euglycemic diabetic ketoacidosis with the use of sodium-glucose cotransporter 2 (SGLT2) inhibitors.

These changes strive to take into account new research, while acknowledging that in some areas there’s still a paucity of data, said Dr. Ratner. For example, recommendations regarding use of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors for certain individuals with dyslipidemia and diabetes are included, though study of this new class of medications is ongoing; the guideline includes an evidence rating system to allow practitioners to rate the strength of recommendations when making individualized treatment decisions.

The guideline also gives the option of adding ezetimibe to a moderate statin dose for some individuals with diabetes and dyslipidemia, acknowledging the findings of the IMPROVE-IT trial. Other atherosclerotic cardiovascular disease updates include considering aspirin therapy for women 50 years and older who have diabetes with at least one additional major risk factor.

A new section devoted to obesity management acknowledges its critical importance in type 2 diabetes mellitus (T2DM). While continuing to emphasize the importance of lifestyle changes, such as healthful eating and physical activity, the guideline acknowledges that there’s a role for pharmacotherapy and surgical treatment. In addition to providing information on approved anti-obesity medication, the guideline addresses the benefit of bariatric surgery for a select group of patients. “We can’t ignore the data” that point toward a role for these interventions for some patients, said Dr. Ratner. The guideline weighs the advantages and disadvantages of each approach.

Other updates include a recommendation for testing all adults for diabetes beginning at age 45 years, without regard to weight; clarifying testing guidelines to emphasize that no one testing strategy is preferred over another; slightly relaxing HbA_1c targets for pregnant women to 6%-6.5%; and enhancing guidelines for hospitalized patients with diabetes.

The complete practice guideline, which runs to 119 pages, is accompanied by an abridged version that provides a basic framework for diabetes management. Dr. Ratner said that the complete standards of care are appropriate for endocrinologists and others who focus on diabetes management, while the abridged version is a resource for primary care providers who may see some patients with diabetes in the mix of their caseload. Both documents are available to view or download free of charge. A summary of key updates precedes the full text of the guidelines, so that those using last year’s guidelines can familiarize themselves quickly with changes in the new version.

Dr. Herman reported chairing data and safety monitoring boards for Merck Sharp & Dohme, and Lexicon Pharmaceuticals. He has served as the editor for the Americas of Diabetic Medicine, and as ad hoc editor in chief of Diabetes Care.

[email protected]

On Twitter @karioakes

VANCOUVER – It may be time to reconsider the criteria used to select obese patients with type 2 diabetes mellitus for bariatric surgery, according to data from a pooled cohort study.

Typically, diabetic patients are considered eligible only if they have a body mass index of at least 35 kg/m² and poorly controlled glycemia, according to lead author Dr. Geltrude Mingrone, department of internal medicine, Catholic University, Rome, and department of diabetes and nutritional sciences, King’s College, London.

But in her team’s new analysis of 727 patients, the best predictors of remission after bariatric surgery were a lower fasting glucose level, shorter diabetes duration at baseline, and having a gastric procedure with diversion, she reported at the World Diabetes Congress. And the best baseline predictors of improved glycemic control after bariatric surgery were lower waist circumference, better diabetes control, and lower triglyceride levels.

“We can say that there is a clear advantage of an early operation on diabetes remission that is independent of baseline body mass index. Baseline waist circumference and HOMA-IR [homeostasis model assessment of insulin resistance] are better predictors of glycemic control after bariatric surgery than body mass index,” Dr. Mingrone maintained.

“So I would like to advise the scientific community … to try to define new criteria for the selection of diabetic patients for metabolic surgery. Also, [it is important] because all over the world, the number of bariatric operations is only 250,000, a quarter of a million, while the potential eligible patients are many, many millions,” she concluded.

“I completely concur with Professor Mingrone – we need to come up with criteria for utilizing this procedure,” session comoderator Dr. Robert E. Ratner said in an interview.

“There are so many millions of individuals with diabetes, we cannot be doing surgery on all of them. We need to be selective, and we need to be very specific about why we are doing it and what we are looking for,” elaborated Dr. Rattner, who is a professor of medicine at Georgetown University and senior research scientist at the MedStar Health Research Institute, Washington, as well as chief scientific and medical officer of the American Diabetes Association, Alexandria, Va.

In the new research, the investigators merged databases of the Swedish Obese Subjects (SOS) prospective controlled study (N Engl J Med. 2004;351:2683-93) and two randomized, controlled trials conducted in Australia (JAMA. 2008;299:316-23) and Italy (N Engl J Med. 2012;366:1577-85).

Overall, 415 patients had bariatric surgery (about three-fourths had a gastric-only procedure, while the rest had a gastric procedure plus diversion) and 312 patients had medical management. The mean duration of diabetes at baseline was roughly 3.5 years.

After 2 years the proportion of patients achieving diabetes remission, defined as a fasting plasma glucose of less than 5.6 mmol/L in the absence of any antidiabetes medication, was higher in the surgical group than in the medical group (64% vs. 15%, P less than .001). And within the surgical group, it was higher for those whose operation included a diversion (76% vs. 60%, P = .016).

Among the patients who had surgery, the probability of remission fell with increasing baseline diabetes duration (–0.210), and fasting blood glucose level (–0.145), whereas it rose with increasing body mass index (+0.059). But when the type of surgery was added to the model, body mass index was no longer a significant predictor, and two additional predictors emerged: use of only oral antidiabetic medications versus none (–1.22) and receipt of a procedure with diversion (2.180).

In the subgroup who had a gastric-only procedure, the probability of remission fell with increasing diabetes duration (–0.197), and increasing fasting blood glucose level (–0.186), and it was lower for patients who used only oral antidiabetic medications (–1.364) or insulin with or without oral medications (–1.783). In the subgroup who had a gastric procedure with diversion, the only predictor was diabetes duration (–0.273).

Of note, there was no significant difference in the odds of remission between patients with a body mass index of 35 kg/m² or lower and patients with a body index between 35 and 40 kg/m².

Dr. Mingrone disclosed that she receives lecture fees and travel expenses from Novo Nordisk, and research grants from AstraZeneca, and is a consultant to Fractyl.

VANCOUVER – It may be time to reconsider the criteria used to select obese patients with type 2 diabetes mellitus for bariatric surgery, according to data from a pooled cohort study.

Typically, diabetic patients are considered eligible only if they have a body mass index of at least 35 kg/m² and poorly controlled glycemia, according to lead author Dr. Geltrude Mingrone, department of internal medicine, Catholic University, Rome, and department of diabetes and nutritional sciences, King’s College, London.

But in her team’s new analysis of 727 patients, the best predictors of remission after bariatric surgery were a lower fasting glucose level, shorter diabetes duration at baseline, and having a gastric procedure with diversion, she reported at the World Diabetes Congress. And the best baseline predictors of improved glycemic control after bariatric surgery were lower waist circumference, better diabetes control, and lower triglyceride levels.

“We can say that there is a clear advantage of an early operation on diabetes remission that is independent of baseline body mass index. Baseline waist circumference and HOMA-IR [homeostasis model assessment of insulin resistance] are better predictors of glycemic control after bariatric surgery than body mass index,” Dr. Mingrone maintained.

“So I would like to advise the scientific community … to try to define new criteria for the selection of diabetic patients for metabolic surgery. Also, [it is important] because all over the world, the number of bariatric operations is only 250,000, a quarter of a million, while the potential eligible patients are many, many millions,” she concluded.

“I completely concur with Professor Mingrone – we need to come up with criteria for utilizing this procedure,” session comoderator Dr. Robert E. Ratner said in an interview.

“There are so many millions of individuals with diabetes, we cannot be doing surgery on all of them. We need to be selective, and we need to be very specific about why we are doing it and what we are looking for,” elaborated Dr. Rattner, who is a professor of medicine at Georgetown University and senior research scientist at the MedStar Health Research Institute, Washington, as well as chief scientific and medical officer of the American Diabetes Association, Alexandria, Va.

In the new research, the investigators merged databases of the Swedish Obese Subjects (SOS) prospective controlled study (N Engl J Med. 2004;351:2683-93) and two randomized, controlled trials conducted in Australia (JAMA. 2008;299:316-23) and Italy (N Engl J Med. 2012;366:1577-85).

Overall, 415 patients had bariatric surgery (about three-fourths had a gastric-only procedure, while the rest had a gastric procedure plus diversion) and 312 patients had medical management. The mean duration of diabetes at baseline was roughly 3.5 years.

After 2 years the proportion of patients achieving diabetes remission, defined as a fasting plasma glucose of less than 5.6 mmol/L in the absence of any antidiabetes medication, was higher in the surgical group than in the medical group (64% vs. 15%, P less than .001). And within the surgical group, it was higher for those whose operation included a diversion (76% vs. 60%, P = .016).

Among the patients who had surgery, the probability of remission fell with increasing baseline diabetes duration (–0.210), and fasting blood glucose level (–0.145), whereas it rose with increasing body mass index (+0.059). But when the type of surgery was added to the model, body mass index was no longer a significant predictor, and two additional predictors emerged: use of only oral antidiabetic medications versus none (–1.22) and receipt of a procedure with diversion (2.180).

In the subgroup who had a gastric-only procedure, the probability of remission fell with increasing diabetes duration (–0.197), and increasing fasting blood glucose level (–0.186), and it was lower for patients who used only oral antidiabetic medications (–1.364) or insulin with or without oral medications (–1.783). In the subgroup who had a gastric procedure with diversion, the only predictor was diabetes duration (–0.273).

Of note, there was no significant difference in the odds of remission between patients with a body mass index of 35 kg/m² or lower and patients with a body index between 35 and 40 kg/m².

Dr. Mingrone disclosed that she receives lecture fees and travel expenses from Novo Nordisk, and research grants from AstraZeneca, and is a consultant to Fractyl.

VANCOUVER – It may be time to reconsider the criteria used to select obese patients with type 2 diabetes mellitus for bariatric surgery, according to data from a pooled cohort study.

Typically, diabetic patients are considered eligible only if they have a body mass index of at least 35 kg/m² and poorly controlled glycemia, according to lead author Dr. Geltrude Mingrone, department of internal medicine, Catholic University, Rome, and department of diabetes and nutritional sciences, King’s College, London.

But in her team’s new analysis of 727 patients, the best predictors of remission after bariatric surgery were a lower fasting glucose level, shorter diabetes duration at baseline, and having a gastric procedure with diversion, she reported at the World Diabetes Congress. And the best baseline predictors of improved glycemic control after bariatric surgery were lower waist circumference, better diabetes control, and lower triglyceride levels.

“We can say that there is a clear advantage of an early operation on diabetes remission that is independent of baseline body mass index. Baseline waist circumference and HOMA-IR [homeostasis model assessment of insulin resistance] are better predictors of glycemic control after bariatric surgery than body mass index,” Dr. Mingrone maintained.

“So I would like to advise the scientific community … to try to define new criteria for the selection of diabetic patients for metabolic surgery. Also, [it is important] because all over the world, the number of bariatric operations is only 250,000, a quarter of a million, while the potential eligible patients are many, many millions,” she concluded.

“I completely concur with Professor Mingrone – we need to come up with criteria for utilizing this procedure,” session comoderator Dr. Robert E. Ratner said in an interview.

“There are so many millions of individuals with diabetes, we cannot be doing surgery on all of them. We need to be selective, and we need to be very specific about why we are doing it and what we are looking for,” elaborated Dr. Rattner, who is a professor of medicine at Georgetown University and senior research scientist at the MedStar Health Research Institute, Washington, as well as chief scientific and medical officer of the American Diabetes Association, Alexandria, Va.

In the new research, the investigators merged databases of the Swedish Obese Subjects (SOS) prospective controlled study (N Engl J Med. 2004;351:2683-93) and two randomized, controlled trials conducted in Australia (JAMA. 2008;299:316-23) and Italy (N Engl J Med. 2012;366:1577-85).

Overall, 415 patients had bariatric surgery (about three-fourths had a gastric-only procedure, while the rest had a gastric procedure plus diversion) and 312 patients had medical management. The mean duration of diabetes at baseline was roughly 3.5 years.

After 2 years the proportion of patients achieving diabetes remission, defined as a fasting plasma glucose of less than 5.6 mmol/L in the absence of any antidiabetes medication, was higher in the surgical group than in the medical group (64% vs. 15%, P less than .001). And within the surgical group, it was higher for those whose operation included a diversion (76% vs. 60%, P = .016).

Among the patients who had surgery, the probability of remission fell with increasing baseline diabetes duration (–0.210), and fasting blood glucose level (–0.145), whereas it rose with increasing body mass index (+0.059). But when the type of surgery was added to the model, body mass index was no longer a significant predictor, and two additional predictors emerged: use of only oral antidiabetic medications versus none (–1.22) and receipt of a procedure with diversion (2.180).

In the subgroup who had a gastric-only procedure, the probability of remission fell with increasing diabetes duration (–0.197), and increasing fasting blood glucose level (–0.186), and it was lower for patients who used only oral antidiabetic medications (–1.364) or insulin with or without oral medications (–1.783). In the subgroup who had a gastric procedure with diversion, the only predictor was diabetes duration (–0.273).

Of note, there was no significant difference in the odds of remission between patients with a body mass index of 35 kg/m² or lower and patients with a body index between 35 and 40 kg/m².

Dr. Mingrone disclosed that she receives lecture fees and travel expenses from Novo Nordisk, and research grants from AstraZeneca, and is a consultant to Fractyl.

People with rheumatoid arthritis who take oral glucocorticoids have an increased risk of diabetes, the magnitude of which is dependent on dose and treatment duration, based on an analysis of two databases.

Dr. Mohammad Movahedi of the Arthritis Research UK Centre for Epidemiology at the University of Manchester (England) led researchers conducting the observational study using the U.K. primary care database (CPRD) of 21,962 RA patients and the U.S. National Data Bank for Rheumatic Diseases (NDB) involving 12,657 RA patients (Arthritis Rheumatol. 2015 Dec 14. doi: 10.1002/art.39537).

©Tashatuvango/Thinkstockphotos.com

The hazard ratio (HR) for developing diabetes was 1.30 (95% confidence interval, 1.17-1.45) for patients taking oral glucocorticoids in the CPRD cohort and 1.61 (95% CI, 1.37-1.89) for people in the NDB cohort.

While doses taken more than 6 months ago did not influence current risk, each 5-mg increase of current oral glucocorticoid dose was associated with a 25% and 30% increased risk of diabetes in the CPRD and NDB cohorts, respectively.

According to the researchers, identifying the risk of diabetes with various doses and durations of therapy allows clinicians and patients to make informed decisions about treatment as well as balance the benefits and harms.

The research team plans to examine the threshold for cost-effective diabetes screening in patients receiving steroids for RA.

Individual investigators reported support for their work from the Medical Research Council, the Canadian Institute for Health Research, the Rheumatology Research Foundation, and the NIHR Manchester Musculoskeletal Biomedical Research Unit. 

People with rheumatoid arthritis who take oral glucocorticoids have an increased risk of diabetes, the magnitude of which is dependent on dose and treatment duration, based on an analysis of two databases.

Dr. Mohammad Movahedi of the Arthritis Research UK Centre for Epidemiology at the University of Manchester (England) led researchers conducting the observational study using the U.K. primary care database (CPRD) of 21,962 RA patients and the U.S. National Data Bank for Rheumatic Diseases (NDB) involving 12,657 RA patients (Arthritis Rheumatol. 2015 Dec 14. doi: 10.1002/art.39537).

©Tashatuvango/Thinkstockphotos.com

The hazard ratio (HR) for developing diabetes was 1.30 (95% confidence interval, 1.17-1.45) for patients taking oral glucocorticoids in the CPRD cohort and 1.61 (95% CI, 1.37-1.89) for people in the NDB cohort.

While doses taken more than 6 months ago did not influence current risk, each 5-mg increase of current oral glucocorticoid dose was associated with a 25% and 30% increased risk of diabetes in the CPRD and NDB cohorts, respectively.

According to the researchers, identifying the risk of diabetes with various doses and durations of therapy allows clinicians and patients to make informed decisions about treatment as well as balance the benefits and harms.

The research team plans to examine the threshold for cost-effective diabetes screening in patients receiving steroids for RA.

Individual investigators reported support for their work from the Medical Research Council, the Canadian Institute for Health Research, the Rheumatology Research Foundation, and the NIHR Manchester Musculoskeletal Biomedical Research Unit. 

People with rheumatoid arthritis who take oral glucocorticoids have an increased risk of diabetes, the magnitude of which is dependent on dose and treatment duration, based on an analysis of two databases.

Dr. Mohammad Movahedi of the Arthritis Research UK Centre for Epidemiology at the University of Manchester (England) led researchers conducting the observational study using the U.K. primary care database (CPRD) of 21,962 RA patients and the U.S. National Data Bank for Rheumatic Diseases (NDB) involving 12,657 RA patients (Arthritis Rheumatol. 2015 Dec 14. doi: 10.1002/art.39537).

©Tashatuvango/Thinkstockphotos.com

The hazard ratio (HR) for developing diabetes was 1.30 (95% confidence interval, 1.17-1.45) for patients taking oral glucocorticoids in the CPRD cohort and 1.61 (95% CI, 1.37-1.89) for people in the NDB cohort.

While doses taken more than 6 months ago did not influence current risk, each 5-mg increase of current oral glucocorticoid dose was associated with a 25% and 30% increased risk of diabetes in the CPRD and NDB cohorts, respectively.

According to the researchers, identifying the risk of diabetes with various doses and durations of therapy allows clinicians and patients to make informed decisions about treatment as well as balance the benefits and harms.

The research team plans to examine the threshold for cost-effective diabetes screening in patients receiving steroids for RA.

Individual investigators reported support for their work from the Medical Research Council, the Canadian Institute for Health Research, the Rheumatology Research Foundation, and the NIHR Manchester Musculoskeletal Biomedical Research Unit. 

VANCOUVER – Perhaps in the not-too-distant future, people at risk for type 1 diabetes will be screened for antibodies against beta cells, and, if two or more are present, started on immunotherapy to prevent beta cell destruction and clinical disease.

The vision is to treat “islet autoimmunity” as we do hypertension and other silent diseases to prevent problems down the road.

In the everyday medical world, that’s mostly science fiction for now – treatment starts when symptoms emerge – but researchers around the world are working hard to make it a reality, including Dr. Carla J. Greenbaum, director of the Diabetes Research Program at the Benaroya Research Institute in Seattle.

It’s known now that when babies have two or more antibodies against beta cells, about 11% per year will develop clinical diabetes, and all of them eventually. Adults with two or more antibodies will also develop diabetes, although at a slower rate than children.

“The take-home message is that type 1 diabetes starts when you have two antibodies. We need to change from symptom management to disease-modifying therapy, and that will require immunotherapy; it will be the future of diabetes care. Endocrinologists need to learn about immunotherapy,” Dr. Greenbaum said at the World Diabetes Congress.

So far, studies of four immunotherapies – teplizumab (Diabetes. 2013 Nov;62[11]:3766-74), rituximab (N Engl J Med. 2009 Nov 26;361[22]:2143-52), abatacept (Diabetes Care. 2014 Apr;37[4]:1069-75), and, most recently, alefacept (J Clin Invest. 2015 Aug 3;125[8]:3285-96) – have shown positive outcomes in preserving beta cell function after diagnosis of type 1. “The positive results are largely driven by children,” she said, suggesting that they might benefit most from a screen-and-treat approach to islet autoimmunity.

Teplizumab, oral insulin, and abatacept are now being tested in antibody-positive patients who haven’t developed symptoms. The trials aim to reduce the risk of clinical disease by 40%. If successful, treating 100 people with islet autoimmunity would prevent 14 from getting clinical type 1 diabetes, said Dr. Greenbaum, who is involved in the work.

A lot of questions need to be answered if the results pan out. Who should be screened, for instance, and how, and what immunotherapies should be used in different patient groups? What’s the right balance between risks and benefits?

There’s also a big question about how to “bring disease-modifying therapies to the clinic. As endocrinologists, we don’t use immunotherapies, but it’s important to recognize that millions of people for many decades have been using them safely to change the course of disease. We need to learn how to do this,” Dr. Greenbaum said.

“I often get people saying immunotherapy doesn’t really work, but that’s not true.” The effect sizes are small – maybe 20% – but it’s the same case in multiple sclerosis and rheumatoid arthritis. “The issue is if you have a weak joint, and you are 20% better, you feel it, but if beta cells are doing better, you might not notice,” she said.

Dr. Greenbaum disclosed research support from Novo Nordisk.

[email protected]

VANCOUVER – Perhaps in the not-too-distant future, people at risk for type 1 diabetes will be screened for antibodies against beta cells, and, if two or more are present, started on immunotherapy to prevent beta cell destruction and clinical disease.

The vision is to treat “islet autoimmunity” as we do hypertension and other silent diseases to prevent problems down the road.

In the everyday medical world, that’s mostly science fiction for now – treatment starts when symptoms emerge – but researchers around the world are working hard to make it a reality, including Dr. Carla J. Greenbaum, director of the Diabetes Research Program at the Benaroya Research Institute in Seattle.

It’s known now that when babies have two or more antibodies against beta cells, about 11% per year will develop clinical diabetes, and all of them eventually. Adults with two or more antibodies will also develop diabetes, although at a slower rate than children.

“The take-home message is that type 1 diabetes starts when you have two antibodies. We need to change from symptom management to disease-modifying therapy, and that will require immunotherapy; it will be the future of diabetes care. Endocrinologists need to learn about immunotherapy,” Dr. Greenbaum said at the World Diabetes Congress.

So far, studies of four immunotherapies – teplizumab (Diabetes. 2013 Nov;62[11]:3766-74), rituximab (N Engl J Med. 2009 Nov 26;361[22]:2143-52), abatacept (Diabetes Care. 2014 Apr;37[4]:1069-75), and, most recently, alefacept (J Clin Invest. 2015 Aug 3;125[8]:3285-96) – have shown positive outcomes in preserving beta cell function after diagnosis of type 1. “The positive results are largely driven by children,” she said, suggesting that they might benefit most from a screen-and-treat approach to islet autoimmunity.

Teplizumab, oral insulin, and abatacept are now being tested in antibody-positive patients who haven’t developed symptoms. The trials aim to reduce the risk of clinical disease by 40%. If successful, treating 100 people with islet autoimmunity would prevent 14 from getting clinical type 1 diabetes, said Dr. Greenbaum, who is involved in the work.

A lot of questions need to be answered if the results pan out. Who should be screened, for instance, and how, and what immunotherapies should be used in different patient groups? What’s the right balance between risks and benefits?

There’s also a big question about how to “bring disease-modifying therapies to the clinic. As endocrinologists, we don’t use immunotherapies, but it’s important to recognize that millions of people for many decades have been using them safely to change the course of disease. We need to learn how to do this,” Dr. Greenbaum said.

“I often get people saying immunotherapy doesn’t really work, but that’s not true.” The effect sizes are small – maybe 20% – but it’s the same case in multiple sclerosis and rheumatoid arthritis. “The issue is if you have a weak joint, and you are 20% better, you feel it, but if beta cells are doing better, you might not notice,” she said.

Dr. Greenbaum disclosed research support from Novo Nordisk.

[email protected]

VANCOUVER – Perhaps in the not-too-distant future, people at risk for type 1 diabetes will be screened for antibodies against beta cells, and, if two or more are present, started on immunotherapy to prevent beta cell destruction and clinical disease.

The vision is to treat “islet autoimmunity” as we do hypertension and other silent diseases to prevent problems down the road.

In the everyday medical world, that’s mostly science fiction for now – treatment starts when symptoms emerge – but researchers around the world are working hard to make it a reality, including Dr. Carla J. Greenbaum, director of the Diabetes Research Program at the Benaroya Research Institute in Seattle.

It’s known now that when babies have two or more antibodies against beta cells, about 11% per year will develop clinical diabetes, and all of them eventually. Adults with two or more antibodies will also develop diabetes, although at a slower rate than children.

“The take-home message is that type 1 diabetes starts when you have two antibodies. We need to change from symptom management to disease-modifying therapy, and that will require immunotherapy; it will be the future of diabetes care. Endocrinologists need to learn about immunotherapy,” Dr. Greenbaum said at the World Diabetes Congress.

So far, studies of four immunotherapies – teplizumab (Diabetes. 2013 Nov;62[11]:3766-74), rituximab (N Engl J Med. 2009 Nov 26;361[22]:2143-52), abatacept (Diabetes Care. 2014 Apr;37[4]:1069-75), and, most recently, alefacept (J Clin Invest. 2015 Aug 3;125[8]:3285-96) – have shown positive outcomes in preserving beta cell function after diagnosis of type 1. “The positive results are largely driven by children,” she said, suggesting that they might benefit most from a screen-and-treat approach to islet autoimmunity.

Teplizumab, oral insulin, and abatacept are now being tested in antibody-positive patients who haven’t developed symptoms. The trials aim to reduce the risk of clinical disease by 40%. If successful, treating 100 people with islet autoimmunity would prevent 14 from getting clinical type 1 diabetes, said Dr. Greenbaum, who is involved in the work.

A lot of questions need to be answered if the results pan out. Who should be screened, for instance, and how, and what immunotherapies should be used in different patient groups? What’s the right balance between risks and benefits?

There’s also a big question about how to “bring disease-modifying therapies to the clinic. As endocrinologists, we don’t use immunotherapies, but it’s important to recognize that millions of people for many decades have been using them safely to change the course of disease. We need to learn how to do this,” Dr. Greenbaum said.

“I often get people saying immunotherapy doesn’t really work, but that’s not true.” The effect sizes are small – maybe 20% – but it’s the same case in multiple sclerosis and rheumatoid arthritis. “The issue is if you have a weak joint, and you are 20% better, you feel it, but if beta cells are doing better, you might not notice,” she said.

Dr. Greenbaum disclosed research support from Novo Nordisk.

[email protected]

VANCOUVER – Taking frequent 5-minute breaks from prolonged sitting to stand or walk at a leisurely pace improved the metabolic response to a meal in heavy postmenopausal women with dysglycemia in a randomized trial reported at the World Diabetes Congress.

The incremental area under the curve for glucose levels after a meal was 34% lower with standing breaks and 28% lower with light walking breaks, compared with uninterrupted, prolonged sitting. Moreover, these benefits persisted into the next day.

Findings were similar for levels of insulin (20% and 37% reductions in response) and for the suppression of nonesterified fatty acids (33% and 47% reductions in response).

“The results of this trial provide new experimental evidence that simply breaking up sedentary behavior appears to have quite an acute positive effect in overweight or obese women with a high risk of type 2 diabetes, and it may last for at least 24 hours after the initial activity stimulus,” commented first author Joseph Henson, Ph.D., a research associate at the Diabetes Research Centre at the University of Leicester in England.

“This simple behavioral approach could inform future public health interventions aimed at improving the metabolic profile of dysglycemic individuals if we are able to prove this in large numbers and also in men,” he added.

“I think as a proof of principle, this study was fascinating,” commented session comoderator Dr. Robert E. Ratner, professor of medicine at Georgetown University and senior research scientist at the MedStar Health Research Institute, Washington, as well as chief scientific and medical officer of the American Diabetes Association.

However, the uninterrupted sitting condition was not realistic, he noted in an interview. “The bottom line is that none of us are escorted to the lavatory by wheelchairs, so the control situation is somewhat limited. But I think that it points out that all of us need to sit less and move more.”

A session attendee noted that the findings for simple standing and with regard to the persistence of the effects over time were somewhat surprising.

The “difference I would have thought previously would have been driven by energy expenditure. So I would have said individuals would have to get up and move in order to see a difference,” Dr. Henson acknowledged. “But we were noticing that [benefit] even with standing. So maybe there is something happening at the level of the muscle, which is inducing the responses.”

As for the persistence of the metabolic benefit, more research will be needed, he said. In particular, studies should assess exactly how long it lasts.

“I think the main conclusion is, simply put, that you can break sitting time with anything, whether it’s standing or walking, and you are likely to get some sort of effect,” Dr. Henson said. Also, individuals should “try and use a stepped approach, so going from sitting to standing, and from standing to walking. The more you move, the better the health outcomes will be.”

Women were eligible for the trial if they were overweight or obese, postmenopausal, aged 50-75 years, and had impaired glucose tolerance or a glycated hemoglobin level of 5.7%-6.4%. “These characteristics are really important because these are the sorts of individuals who are likely to be identified and referred into relevant diabetes prevention programs,” Dr. Henson commented. In addition, the women had to be sedentary, engaging in less than 150 minutes of regular purposeful activity each week.

They each participated in two of three activities on separate days: unbroken prolonged sitting for 7.5 hours (interrupted only by trips to the restroom by wheelchair); prolonged sitting, broken up with 5-minute bouts of standing every 30 minutes; and prolonged sitting, broken up with 5-minute bouts of light-intensity walking (up to 2.5 mph) on a treadmill every 30 minutes.

Midway through each day, the women were given a high-fat meal. Serial blood samples were collected throughout the day for measurement of cardiometabolic markers.

Study results, reported at the congress and recently published (Diabetes Care. 2015 Dec 1. doi: 10.2337/dc15-1240), showed that the incremental area under the curve was 5.3 mmol/L per hour with unbroken prolonged sitting, but it was lower at 3.5 mmol/L per hour with standing breaks and 3.8 mmol/L per hour with sitting breaks (P less than .05 for each difference vs. sitting).

Respective values were 548.2, 437.2, and 347.9 mU/L per hour for insulin levels (P less than .05 for each difference vs. sitting), and –1.5, –1.0, and –0.8 mmol/L per hour for suppression of nonesterified fatty acid levels (P less than .05 for each difference vs. sitting).

In contrast, neither type of activity break significantly affected the triglyceride response to a meal or altered blood pressure, according to Dr. Henson, who disclosed that he received support for the presentation from the International Diabetes Federation–American Diabetes Association.

[email protected]

VANCOUVER – Taking frequent 5-minute breaks from prolonged sitting to stand or walk at a leisurely pace improved the metabolic response to a meal in heavy postmenopausal women with dysglycemia in a randomized trial reported at the World Diabetes Congress.

The incremental area under the curve for glucose levels after a meal was 34% lower with standing breaks and 28% lower with light walking breaks, compared with uninterrupted, prolonged sitting. Moreover, these benefits persisted into the next day.

Findings were similar for levels of insulin (20% and 37% reductions in response) and for the suppression of nonesterified fatty acids (33% and 47% reductions in response).

“The results of this trial provide new experimental evidence that simply breaking up sedentary behavior appears to have quite an acute positive effect in overweight or obese women with a high risk of type 2 diabetes, and it may last for at least 24 hours after the initial activity stimulus,” commented first author Joseph Henson, Ph.D., a research associate at the Diabetes Research Centre at the University of Leicester in England.

“This simple behavioral approach could inform future public health interventions aimed at improving the metabolic profile of dysglycemic individuals if we are able to prove this in large numbers and also in men,” he added.

“I think as a proof of principle, this study was fascinating,” commented session comoderator Dr. Robert E. Ratner, professor of medicine at Georgetown University and senior research scientist at the MedStar Health Research Institute, Washington, as well as chief scientific and medical officer of the American Diabetes Association.

However, the uninterrupted sitting condition was not realistic, he noted in an interview. “The bottom line is that none of us are escorted to the lavatory by wheelchairs, so the control situation is somewhat limited. But I think that it points out that all of us need to sit less and move more.”

A session attendee noted that the findings for simple standing and with regard to the persistence of the effects over time were somewhat surprising.

The “difference I would have thought previously would have been driven by energy expenditure. So I would have said individuals would have to get up and move in order to see a difference,” Dr. Henson acknowledged. “But we were noticing that [benefit] even with standing. So maybe there is something happening at the level of the muscle, which is inducing the responses.”

As for the persistence of the metabolic benefit, more research will be needed, he said. In particular, studies should assess exactly how long it lasts.

“I think the main conclusion is, simply put, that you can break sitting time with anything, whether it’s standing or walking, and you are likely to get some sort of effect,” Dr. Henson said. Also, individuals should “try and use a stepped approach, so going from sitting to standing, and from standing to walking. The more you move, the better the health outcomes will be.”

Women were eligible for the trial if they were overweight or obese, postmenopausal, aged 50-75 years, and had impaired glucose tolerance or a glycated hemoglobin level of 5.7%-6.4%. “These characteristics are really important because these are the sorts of individuals who are likely to be identified and referred into relevant diabetes prevention programs,” Dr. Henson commented. In addition, the women had to be sedentary, engaging in less than 150 minutes of regular purposeful activity each week.

They each participated in two of three activities on separate days: unbroken prolonged sitting for 7.5 hours (interrupted only by trips to the restroom by wheelchair); prolonged sitting, broken up with 5-minute bouts of standing every 30 minutes; and prolonged sitting, broken up with 5-minute bouts of light-intensity walking (up to 2.5 mph) on a treadmill every 30 minutes.

Midway through each day, the women were given a high-fat meal. Serial blood samples were collected throughout the day for measurement of cardiometabolic markers.

Study results, reported at the congress and recently published (Diabetes Care. 2015 Dec 1. doi: 10.2337/dc15-1240), showed that the incremental area under the curve was 5.3 mmol/L per hour with unbroken prolonged sitting, but it was lower at 3.5 mmol/L per hour with standing breaks and 3.8 mmol/L per hour with sitting breaks (P less than .05 for each difference vs. sitting).

Respective values were 548.2, 437.2, and 347.9 mU/L per hour for insulin levels (P less than .05 for each difference vs. sitting), and –1.5, –1.0, and –0.8 mmol/L per hour for suppression of nonesterified fatty acid levels (P less than .05 for each difference vs. sitting).

In contrast, neither type of activity break significantly affected the triglyceride response to a meal or altered blood pressure, according to Dr. Henson, who disclosed that he received support for the presentation from the International Diabetes Federation–American Diabetes Association.

[email protected]

VANCOUVER – Taking frequent 5-minute breaks from prolonged sitting to stand or walk at a leisurely pace improved the metabolic response to a meal in heavy postmenopausal women with dysglycemia in a randomized trial reported at the World Diabetes Congress.

The incremental area under the curve for glucose levels after a meal was 34% lower with standing breaks and 28% lower with light walking breaks, compared with uninterrupted, prolonged sitting. Moreover, these benefits persisted into the next day.

Findings were similar for levels of insulin (20% and 37% reductions in response) and for the suppression of nonesterified fatty acids (33% and 47% reductions in response).

“The results of this trial provide new experimental evidence that simply breaking up sedentary behavior appears to have quite an acute positive effect in overweight or obese women with a high risk of type 2 diabetes, and it may last for at least 24 hours after the initial activity stimulus,” commented first author Joseph Henson, Ph.D., a research associate at the Diabetes Research Centre at the University of Leicester in England.

“This simple behavioral approach could inform future public health interventions aimed at improving the metabolic profile of dysglycemic individuals if we are able to prove this in large numbers and also in men,” he added.

“I think as a proof of principle, this study was fascinating,” commented session comoderator Dr. Robert E. Ratner, professor of medicine at Georgetown University and senior research scientist at the MedStar Health Research Institute, Washington, as well as chief scientific and medical officer of the American Diabetes Association.

However, the uninterrupted sitting condition was not realistic, he noted in an interview. “The bottom line is that none of us are escorted to the lavatory by wheelchairs, so the control situation is somewhat limited. But I think that it points out that all of us need to sit less and move more.”

A session attendee noted that the findings for simple standing and with regard to the persistence of the effects over time were somewhat surprising.

The “difference I would have thought previously would have been driven by energy expenditure. So I would have said individuals would have to get up and move in order to see a difference,” Dr. Henson acknowledged. “But we were noticing that [benefit] even with standing. So maybe there is something happening at the level of the muscle, which is inducing the responses.”

As for the persistence of the metabolic benefit, more research will be needed, he said. In particular, studies should assess exactly how long it lasts.

“I think the main conclusion is, simply put, that you can break sitting time with anything, whether it’s standing or walking, and you are likely to get some sort of effect,” Dr. Henson said. Also, individuals should “try and use a stepped approach, so going from sitting to standing, and from standing to walking. The more you move, the better the health outcomes will be.”

Women were eligible for the trial if they were overweight or obese, postmenopausal, aged 50-75 years, and had impaired glucose tolerance or a glycated hemoglobin level of 5.7%-6.4%. “These characteristics are really important because these are the sorts of individuals who are likely to be identified and referred into relevant diabetes prevention programs,” Dr. Henson commented. In addition, the women had to be sedentary, engaging in less than 150 minutes of regular purposeful activity each week.

They each participated in two of three activities on separate days: unbroken prolonged sitting for 7.5 hours (interrupted only by trips to the restroom by wheelchair); prolonged sitting, broken up with 5-minute bouts of standing every 30 minutes; and prolonged sitting, broken up with 5-minute bouts of light-intensity walking (up to 2.5 mph) on a treadmill every 30 minutes.

Midway through each day, the women were given a high-fat meal. Serial blood samples were collected throughout the day for measurement of cardiometabolic markers.

Study results, reported at the congress and recently published (Diabetes Care. 2015 Dec 1. doi: 10.2337/dc15-1240), showed that the incremental area under the curve was 5.3 mmol/L per hour with unbroken prolonged sitting, but it was lower at 3.5 mmol/L per hour with standing breaks and 3.8 mmol/L per hour with sitting breaks (P less than .05 for each difference vs. sitting).

Respective values were 548.2, 437.2, and 347.9 mU/L per hour for insulin levels (P less than .05 for each difference vs. sitting), and –1.5, –1.0, and –0.8 mmol/L per hour for suppression of nonesterified fatty acid levels (P less than .05 for each difference vs. sitting).

In contrast, neither type of activity break significantly affected the triglyceride response to a meal or altered blood pressure, according to Dr. Henson, who disclosed that he received support for the presentation from the International Diabetes Federation–American Diabetes Association.

[email protected]

VANCOUVER – When diabetes is diagnosed from ages 15 to 30 years, type 2 patients are less likely than are type 1 patients to reach their 50th birthday, according to investigators from the University of Sydney.

Even just a few years after diagnosis, young type 2 patients have a worse cardiovascular profile and worse cardiovascular disease, which leads to an earlier death.

“We pay less attention to type 2 than type 1 in young people. They’re not as sick, and don’t develop [diabetic ketoacidosis] if they miss a treatment. But young type 2 is not a milder form of diabetes in young people, and its detrimental impact occurs early. Before we know what’s going on, patients are middle age, and it’s too late,” said investigator Maria Constantino, a Ph.D. candidate, nurse, and diabetes researcher and educator at the University of Sydney.

Screening for type 2 diabetes “should start at a young age in at-risk groups,” and diabetes cardiovascular risk criteria should be reconsidered so that younger type 2 patients aren’t overlooked because of their age. Current criteria likely “lead to delay in preventive treatment” in the young, she said.

The conclusions come from a review of diabetes patients treated since 1990 at the Royal Prince Alfred Hospital in Sydney (Diabetes Care. 2013 Dec; 36[12]:3863-9).

The investigators compared 354 type 2 patients with 470 type 1 patients diagnosed from age 15-30 years. By around the age of 40 years, 11% of the type 2 patients had died, vs. 6.8% with type 1 (hazard ratio, 2.0; 95% confidence interval, 1.2-3.2; P = .003). Strokes, coronary artery disease, and other macrovascular complications were also far more common in the type 2 group, and they had worse hypertension and dyslipidemia despite taking more drugs to combat both. Type 2 patients also had more albuminuria and neuropathy.

The differences occurred despite the fact that type 2 patients smoked less, had a slightly shorter duration of disease (11.6 vs. 14.7 years), and equivalent glycemic control with their type 1 counterparts, with a mean hemoglobin A_1c of 8.1% in both groups. They were heavier, however, with a mean body mass index of 32.2 kg/m² vs. 25.6 kg/m² in type 1 patients.

In short, young-onset type 2 is a “more lethal phenotype of diabetes. We are not saying one type of diabetes is more important; we need to conquer both.” But in young type 2 patients, “we need to focus on more than just glycemic control.” Cardiovascular risk factors are “detectable early, and treatable,” Ms. Constantino said.

The investigators also compared their 354 young-onset type 2 patients with 1,062 patients diagnosed from age 40-50 years.

By the time they were about 50 years old, young-onset patients were 6.5 times more likely to have died than were their age-matched peers without diabetes in the general Australian population. The peak in excess mortality for those diagnosed in their 5th decade came at about age of 65 years, with a risk of death about 2.5 times higher than nondiabetic peers in the general population.

“The impact of type 2 is much higher the younger a person is. You can argue that in our enthusiasm to diagnose diabetes, we are casting our screening net wider and wider, and take pride in diagnosing many elderly patients with diabetes, but we should not lose sight of the fact that finding and treating an elderly person with diabetes has much less impact than finding and treating one in a young age group,” she said.

Ms. Constantino has no conflicts of interest.

[email protected]

VANCOUVER – When diabetes is diagnosed from ages 15 to 30 years, type 2 patients are less likely than are type 1 patients to reach their 50th birthday, according to investigators from the University of Sydney.

Even just a few years after diagnosis, young type 2 patients have a worse cardiovascular profile and worse cardiovascular disease, which leads to an earlier death.

“We pay less attention to type 2 than type 1 in young people. They’re not as sick, and don’t develop [diabetic ketoacidosis] if they miss a treatment. But young type 2 is not a milder form of diabetes in young people, and its detrimental impact occurs early. Before we know what’s going on, patients are middle age, and it’s too late,” said investigator Maria Constantino, a Ph.D. candidate, nurse, and diabetes researcher and educator at the University of Sydney.

Screening for type 2 diabetes “should start at a young age in at-risk groups,” and diabetes cardiovascular risk criteria should be reconsidered so that younger type 2 patients aren’t overlooked because of their age. Current criteria likely “lead to delay in preventive treatment” in the young, she said.

The conclusions come from a review of diabetes patients treated since 1990 at the Royal Prince Alfred Hospital in Sydney (Diabetes Care. 2013 Dec; 36[12]:3863-9).

The investigators compared 354 type 2 patients with 470 type 1 patients diagnosed from age 15-30 years. By around the age of 40 years, 11% of the type 2 patients had died, vs. 6.8% with type 1 (hazard ratio, 2.0; 95% confidence interval, 1.2-3.2; P = .003). Strokes, coronary artery disease, and other macrovascular complications were also far more common in the type 2 group, and they had worse hypertension and dyslipidemia despite taking more drugs to combat both. Type 2 patients also had more albuminuria and neuropathy.

The differences occurred despite the fact that type 2 patients smoked less, had a slightly shorter duration of disease (11.6 vs. 14.7 years), and equivalent glycemic control with their type 1 counterparts, with a mean hemoglobin A_1c of 8.1% in both groups. They were heavier, however, with a mean body mass index of 32.2 kg/m² vs. 25.6 kg/m² in type 1 patients.

In short, young-onset type 2 is a “more lethal phenotype of diabetes. We are not saying one type of diabetes is more important; we need to conquer both.” But in young type 2 patients, “we need to focus on more than just glycemic control.” Cardiovascular risk factors are “detectable early, and treatable,” Ms. Constantino said.

The investigators also compared their 354 young-onset type 2 patients with 1,062 patients diagnosed from age 40-50 years.

By the time they were about 50 years old, young-onset patients were 6.5 times more likely to have died than were their age-matched peers without diabetes in the general Australian population. The peak in excess mortality for those diagnosed in their 5th decade came at about age of 65 years, with a risk of death about 2.5 times higher than nondiabetic peers in the general population.

“The impact of type 2 is much higher the younger a person is. You can argue that in our enthusiasm to diagnose diabetes, we are casting our screening net wider and wider, and take pride in diagnosing many elderly patients with diabetes, but we should not lose sight of the fact that finding and treating an elderly person with diabetes has much less impact than finding and treating one in a young age group,” she said.

Ms. Constantino has no conflicts of interest.

[email protected]

VANCOUVER – When diabetes is diagnosed from ages 15 to 30 years, type 2 patients are less likely than are type 1 patients to reach their 50th birthday, according to investigators from the University of Sydney.

Even just a few years after diagnosis, young type 2 patients have a worse cardiovascular profile and worse cardiovascular disease, which leads to an earlier death.

“We pay less attention to type 2 than type 1 in young people. They’re not as sick, and don’t develop [diabetic ketoacidosis] if they miss a treatment. But young type 2 is not a milder form of diabetes in young people, and its detrimental impact occurs early. Before we know what’s going on, patients are middle age, and it’s too late,” said investigator Maria Constantino, a Ph.D. candidate, nurse, and diabetes researcher and educator at the University of Sydney.

Screening for type 2 diabetes “should start at a young age in at-risk groups,” and diabetes cardiovascular risk criteria should be reconsidered so that younger type 2 patients aren’t overlooked because of their age. Current criteria likely “lead to delay in preventive treatment” in the young, she said.

The conclusions come from a review of diabetes patients treated since 1990 at the Royal Prince Alfred Hospital in Sydney (Diabetes Care. 2013 Dec; 36[12]:3863-9).

The investigators compared 354 type 2 patients with 470 type 1 patients diagnosed from age 15-30 years. By around the age of 40 years, 11% of the type 2 patients had died, vs. 6.8% with type 1 (hazard ratio, 2.0; 95% confidence interval, 1.2-3.2; P = .003). Strokes, coronary artery disease, and other macrovascular complications were also far more common in the type 2 group, and they had worse hypertension and dyslipidemia despite taking more drugs to combat both. Type 2 patients also had more albuminuria and neuropathy.

The differences occurred despite the fact that type 2 patients smoked less, had a slightly shorter duration of disease (11.6 vs. 14.7 years), and equivalent glycemic control with their type 1 counterparts, with a mean hemoglobin A_1c of 8.1% in both groups. They were heavier, however, with a mean body mass index of 32.2 kg/m² vs. 25.6 kg/m² in type 1 patients.

In short, young-onset type 2 is a “more lethal phenotype of diabetes. We are not saying one type of diabetes is more important; we need to conquer both.” But in young type 2 patients, “we need to focus on more than just glycemic control.” Cardiovascular risk factors are “detectable early, and treatable,” Ms. Constantino said.

The investigators also compared their 354 young-onset type 2 patients with 1,062 patients diagnosed from age 40-50 years.

By the time they were about 50 years old, young-onset patients were 6.5 times more likely to have died than were their age-matched peers without diabetes in the general Australian population. The peak in excess mortality for those diagnosed in their 5th decade came at about age of 65 years, with a risk of death about 2.5 times higher than nondiabetic peers in the general population.

“The impact of type 2 is much higher the younger a person is. You can argue that in our enthusiasm to diagnose diabetes, we are casting our screening net wider and wider, and take pride in diagnosing many elderly patients with diabetes, but we should not lose sight of the fact that finding and treating an elderly person with diabetes has much less impact than finding and treating one in a young age group,” she said.

Ms. Constantino has no conflicts of interest.

[email protected]

The Food and Drug Administration on Dec. 16 approved Lilly’s Basaglar (insulin glargine injection 100 unit/mL), a long-acting human insulin analog that will compete with Sanofi’s blockbuster Lantus.

Basaglar received tentative approval in 2014, but final approval was held up until the two companies settled a Sanofi lawsuit in September of 2015 that claimed patent infringement on the pen formulation of Lantus. Basaglar will now also have a pen option.

U.S. pricing information hasn’t been released, but in Europe, where Basaglar is already on the market, the pen formulation costs about 15% less than Lantus pens.

The approval was based, in part, on the FDA’s confidence in Lantus, which was approved in 2000. “The applicant demonstrated that Basaglar was sufficiently similar to Lantus to scientifically justify” approval, “and also provided Basaglar-specific data to establish the drug’s safety and efficacy for its approved uses. The Basaglar-specific data included two clinical trials enrolling 534 and 744 patients with type 1 and 2 diabetes mellitus, respectively,” the agency said in a statement.

Basaglar carries the same indications as Lantus to improve glycemic control in adults and children with type 1 diabetes and adults with type 2 diabetes. The agency said Basaglar is meant to be administered once daily at the same time every day. Lantus carries that dosing recommendation, but physicians have come to realize that its duration of action varies, and some now prefer a split dose with two daily injections, believing it provides tighter glycemic control.

“Long-acting insulin products like insulin glargine play an important role in the treatment of types 1 and 2 diabetes mellitus, and today’s approval is expected to expand the availability of treatment options for health care professionals and patients,” Dr. Jean-Marc Guettier, director of the FDA’s Division of Metabolism and Endocrinology Products, said in the agency statement.

Like any insulin, Basaglar can cause life-threatening hypoglycemia, and life-threatening allergic reactions, including anaphylaxis.

Also as with any insulin, the agency noted, Basaglar should not be used during episodes of hypoglycemia, and patients should be monitored more closely when there are “changes to insulin dosage, co-administration of other glucose-lowering medications, meal pattern, physical activity and in patients with renal impairment or hepatic impairment or hypoglycemia unawareness.”

Adverse reactions in trials were generally the same as with Lantus, and included hypoglycemia, allergic reactions, injection site reactions, injection site pitting, itching, rash, edema, and weight gain.

Although considered a Lantus biosimilar by some, the FDA noted that “Basaglar is not approved as a biosimilar product. No insulin glargine products are currently licensed under the Public Health Service Act, so there is no reference product for a proposed biosimilar product.”

[email protected]

The Food and Drug Administration on Dec. 16 approved Lilly’s Basaglar (insulin glargine injection 100 unit/mL), a long-acting human insulin analog that will compete with Sanofi’s blockbuster Lantus.

Basaglar received tentative approval in 2014, but final approval was held up until the two companies settled a Sanofi lawsuit in September of 2015 that claimed patent infringement on the pen formulation of Lantus. Basaglar will now also have a pen option.

U.S. pricing information hasn’t been released, but in Europe, where Basaglar is already on the market, the pen formulation costs about 15% less than Lantus pens.

The approval was based, in part, on the FDA’s confidence in Lantus, which was approved in 2000. “The applicant demonstrated that Basaglar was sufficiently similar to Lantus to scientifically justify” approval, “and also provided Basaglar-specific data to establish the drug’s safety and efficacy for its approved uses. The Basaglar-specific data included two clinical trials enrolling 534 and 744 patients with type 1 and 2 diabetes mellitus, respectively,” the agency said in a statement.

Basaglar carries the same indications as Lantus to improve glycemic control in adults and children with type 1 diabetes and adults with type 2 diabetes. The agency said Basaglar is meant to be administered once daily at the same time every day. Lantus carries that dosing recommendation, but physicians have come to realize that its duration of action varies, and some now prefer a split dose with two daily injections, believing it provides tighter glycemic control.

“Long-acting insulin products like insulin glargine play an important role in the treatment of types 1 and 2 diabetes mellitus, and today’s approval is expected to expand the availability of treatment options for health care professionals and patients,” Dr. Jean-Marc Guettier, director of the FDA’s Division of Metabolism and Endocrinology Products, said in the agency statement.

Like any insulin, Basaglar can cause life-threatening hypoglycemia, and life-threatening allergic reactions, including anaphylaxis.

Also as with any insulin, the agency noted, Basaglar should not be used during episodes of hypoglycemia, and patients should be monitored more closely when there are “changes to insulin dosage, co-administration of other glucose-lowering medications, meal pattern, physical activity and in patients with renal impairment or hepatic impairment or hypoglycemia unawareness.”

Adverse reactions in trials were generally the same as with Lantus, and included hypoglycemia, allergic reactions, injection site reactions, injection site pitting, itching, rash, edema, and weight gain.

Although considered a Lantus biosimilar by some, the FDA noted that “Basaglar is not approved as a biosimilar product. No insulin glargine products are currently licensed under the Public Health Service Act, so there is no reference product for a proposed biosimilar product.”

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The Food and Drug Administration on Dec. 16 approved Lilly’s Basaglar (insulin glargine injection 100 unit/mL), a long-acting human insulin analog that will compete with Sanofi’s blockbuster Lantus.

Basaglar received tentative approval in 2014, but final approval was held up until the two companies settled a Sanofi lawsuit in September of 2015 that claimed patent infringement on the pen formulation of Lantus. Basaglar will now also have a pen option.

U.S. pricing information hasn’t been released, but in Europe, where Basaglar is already on the market, the pen formulation costs about 15% less than Lantus pens.

The approval was based, in part, on the FDA’s confidence in Lantus, which was approved in 2000. “The applicant demonstrated that Basaglar was sufficiently similar to Lantus to scientifically justify” approval, “and also provided Basaglar-specific data to establish the drug’s safety and efficacy for its approved uses. The Basaglar-specific data included two clinical trials enrolling 534 and 744 patients with type 1 and 2 diabetes mellitus, respectively,” the agency said in a statement.

Basaglar carries the same indications as Lantus to improve glycemic control in adults and children with type 1 diabetes and adults with type 2 diabetes. The agency said Basaglar is meant to be administered once daily at the same time every day. Lantus carries that dosing recommendation, but physicians have come to realize that its duration of action varies, and some now prefer a split dose with two daily injections, believing it provides tighter glycemic control.

“Long-acting insulin products like insulin glargine play an important role in the treatment of types 1 and 2 diabetes mellitus, and today’s approval is expected to expand the availability of treatment options for health care professionals and patients,” Dr. Jean-Marc Guettier, director of the FDA’s Division of Metabolism and Endocrinology Products, said in the agency statement.

Like any insulin, Basaglar can cause life-threatening hypoglycemia, and life-threatening allergic reactions, including anaphylaxis.

Also as with any insulin, the agency noted, Basaglar should not be used during episodes of hypoglycemia, and patients should be monitored more closely when there are “changes to insulin dosage, co-administration of other glucose-lowering medications, meal pattern, physical activity and in patients with renal impairment or hepatic impairment or hypoglycemia unawareness.”

Adverse reactions in trials were generally the same as with Lantus, and included hypoglycemia, allergic reactions, injection site reactions, injection site pitting, itching, rash, edema, and weight gain.

Although considered a Lantus biosimilar by some, the FDA noted that “Basaglar is not approved as a biosimilar product. No insulin glargine products are currently licensed under the Public Health Service Act, so there is no reference product for a proposed biosimilar product.”

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