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RISE: Insulin glargine, metformin offer no beta cell function benefit in youth
ORLANDO – in the pediatric medication portion of the Restoring Insulin Secretion (RISE) study.
The treatments, including either metformin for 12 months in 47 participants or insulin glargine for 3 months followed by metformin for 9 months in 44 participants, were not associated with improvement in beta cell function at 12 months, compared with baseline, according to reports from members of the RISE Consortium at the annual scientific sessions of the American Diabetes Association.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Furthermore, measures of beta cell function worsened in both groups at 15-month follow-up, and the same was true for participants with impaired glucose tolerance only; the outcomes in that subset of patients were similar to the entire group, including patients with early T2DM.
“Beta cell failure progressed despite that intervention, and though both [metformin and insulin glargine] were effective for lowering glucose – and metformin for lowering weight ... it had nothing to do with the natural history of the disease, and that’s really quite disappointing,” John B. Buse, MD, said in a video interview.
But that’s not to say the findings weren’t of value.
“The exciting bit was our greater understanding of what’s different about diabetes in youth, and basically [the findings] showed that, both in the setting of impaired glucose tolerance and early diabetes, youth have more insulin resistance than adults, they have relatively more well-preserved beta cell function – they’re secreting more insulin at both impaired glucose tolerance and diabetes, and they have lesser hepatic insulin clearance,” said Dr. Buse, professor, chief of the division of endocrinology, and director of the Diabetes Center at the University of North Carolina, Chapel Hill.
Dr. Buse provided invited commentary on the findings at the ADA scientific sessions and elaborated on those comments in this interview, noting that, in addition to identifying important differences between children and adults with impaired glucose tolerance and diabetes, the RISE study demonstrated that the numerous challenges associated with conducting a major study involving children with impaired glucose tolerance or T2DM can be overcome.
“It’s a really heartwarming story,” he said of the efforts and successes of the RISE investigators in completing the pediatric medication portion of the study. “It at least gives us hope that, even if we haven’t found a cure for type 2 diabetes in children, we at least know we can do the studies.”
Dr. Buse also provided his take on what the future holds for both parts of the RISE study (findings from the adult medication and adult surgery portions are expected to be reported within the next year) and for other studies in children and youth with diabetes; he noted that the current findings and successes in enrolling and completing the pediatric portion of the study highlight multiple opportunities for future research.
Dr. Buse reported financial relationships with Adocia, AstraZeneca, Dexcom, Elcelyx, Eli Lilly, Fractyl Laboratories, Intarcia Therapeutics, Lexicon Pharmaceuticals, Metavention, NovaTarg Therapeutics, Novo Nordisk, Sanofi, VTV Therapeutics, Boehringer Ingelheim, Johnson & Johnson Services, Theracos, Shenzhen Hightide Biopharmaceutical, National Heart Lung and Blood Institute, National Center for Advancing Translational Sciences, National Institute of Diabetes and Digestive and Kidney Diseases, American Diabetes Association, Patient-Centered Outcomes Research Institute, and the National Institute of Environmental Health Sciences.
ORLANDO – in the pediatric medication portion of the Restoring Insulin Secretion (RISE) study.
The treatments, including either metformin for 12 months in 47 participants or insulin glargine for 3 months followed by metformin for 9 months in 44 participants, were not associated with improvement in beta cell function at 12 months, compared with baseline, according to reports from members of the RISE Consortium at the annual scientific sessions of the American Diabetes Association.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Furthermore, measures of beta cell function worsened in both groups at 15-month follow-up, and the same was true for participants with impaired glucose tolerance only; the outcomes in that subset of patients were similar to the entire group, including patients with early T2DM.
“Beta cell failure progressed despite that intervention, and though both [metformin and insulin glargine] were effective for lowering glucose – and metformin for lowering weight ... it had nothing to do with the natural history of the disease, and that’s really quite disappointing,” John B. Buse, MD, said in a video interview.
But that’s not to say the findings weren’t of value.
“The exciting bit was our greater understanding of what’s different about diabetes in youth, and basically [the findings] showed that, both in the setting of impaired glucose tolerance and early diabetes, youth have more insulin resistance than adults, they have relatively more well-preserved beta cell function – they’re secreting more insulin at both impaired glucose tolerance and diabetes, and they have lesser hepatic insulin clearance,” said Dr. Buse, professor, chief of the division of endocrinology, and director of the Diabetes Center at the University of North Carolina, Chapel Hill.
Dr. Buse provided invited commentary on the findings at the ADA scientific sessions and elaborated on those comments in this interview, noting that, in addition to identifying important differences between children and adults with impaired glucose tolerance and diabetes, the RISE study demonstrated that the numerous challenges associated with conducting a major study involving children with impaired glucose tolerance or T2DM can be overcome.
“It’s a really heartwarming story,” he said of the efforts and successes of the RISE investigators in completing the pediatric medication portion of the study. “It at least gives us hope that, even if we haven’t found a cure for type 2 diabetes in children, we at least know we can do the studies.”
Dr. Buse also provided his take on what the future holds for both parts of the RISE study (findings from the adult medication and adult surgery portions are expected to be reported within the next year) and for other studies in children and youth with diabetes; he noted that the current findings and successes in enrolling and completing the pediatric portion of the study highlight multiple opportunities for future research.
Dr. Buse reported financial relationships with Adocia, AstraZeneca, Dexcom, Elcelyx, Eli Lilly, Fractyl Laboratories, Intarcia Therapeutics, Lexicon Pharmaceuticals, Metavention, NovaTarg Therapeutics, Novo Nordisk, Sanofi, VTV Therapeutics, Boehringer Ingelheim, Johnson & Johnson Services, Theracos, Shenzhen Hightide Biopharmaceutical, National Heart Lung and Blood Institute, National Center for Advancing Translational Sciences, National Institute of Diabetes and Digestive and Kidney Diseases, American Diabetes Association, Patient-Centered Outcomes Research Institute, and the National Institute of Environmental Health Sciences.
ORLANDO – in the pediatric medication portion of the Restoring Insulin Secretion (RISE) study.
The treatments, including either metformin for 12 months in 47 participants or insulin glargine for 3 months followed by metformin for 9 months in 44 participants, were not associated with improvement in beta cell function at 12 months, compared with baseline, according to reports from members of the RISE Consortium at the annual scientific sessions of the American Diabetes Association.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Furthermore, measures of beta cell function worsened in both groups at 15-month follow-up, and the same was true for participants with impaired glucose tolerance only; the outcomes in that subset of patients were similar to the entire group, including patients with early T2DM.
“Beta cell failure progressed despite that intervention, and though both [metformin and insulin glargine] were effective for lowering glucose – and metformin for lowering weight ... it had nothing to do with the natural history of the disease, and that’s really quite disappointing,” John B. Buse, MD, said in a video interview.
But that’s not to say the findings weren’t of value.
“The exciting bit was our greater understanding of what’s different about diabetes in youth, and basically [the findings] showed that, both in the setting of impaired glucose tolerance and early diabetes, youth have more insulin resistance than adults, they have relatively more well-preserved beta cell function – they’re secreting more insulin at both impaired glucose tolerance and diabetes, and they have lesser hepatic insulin clearance,” said Dr. Buse, professor, chief of the division of endocrinology, and director of the Diabetes Center at the University of North Carolina, Chapel Hill.
Dr. Buse provided invited commentary on the findings at the ADA scientific sessions and elaborated on those comments in this interview, noting that, in addition to identifying important differences between children and adults with impaired glucose tolerance and diabetes, the RISE study demonstrated that the numerous challenges associated with conducting a major study involving children with impaired glucose tolerance or T2DM can be overcome.
“It’s a really heartwarming story,” he said of the efforts and successes of the RISE investigators in completing the pediatric medication portion of the study. “It at least gives us hope that, even if we haven’t found a cure for type 2 diabetes in children, we at least know we can do the studies.”
Dr. Buse also provided his take on what the future holds for both parts of the RISE study (findings from the adult medication and adult surgery portions are expected to be reported within the next year) and for other studies in children and youth with diabetes; he noted that the current findings and successes in enrolling and completing the pediatric portion of the study highlight multiple opportunities for future research.
Dr. Buse reported financial relationships with Adocia, AstraZeneca, Dexcom, Elcelyx, Eli Lilly, Fractyl Laboratories, Intarcia Therapeutics, Lexicon Pharmaceuticals, Metavention, NovaTarg Therapeutics, Novo Nordisk, Sanofi, VTV Therapeutics, Boehringer Ingelheim, Johnson & Johnson Services, Theracos, Shenzhen Hightide Biopharmaceutical, National Heart Lung and Blood Institute, National Center for Advancing Translational Sciences, National Institute of Diabetes and Digestive and Kidney Diseases, American Diabetes Association, Patient-Centered Outcomes Research Institute, and the National Institute of Environmental Health Sciences.
EXPERT ANALYSIS AT ADA 2018
mSToPS breaks ground as a ‘pragmatic’ randomized trial
The mSToPS study “represents an innovative example of the potential (and challenges) inherent in a pragmatic information technology trial. The trial “represents a brave new world for clinical research: an innovative, highly commendable, contemporary pragmatic health care information technology study that tested an important question and yielded significant clinical findings,” wrote two leaders in trial design in an editorial about the study.
In addition, the mHealth Screening to Prevent Strokes (mSToPS) trial tested the utility of a wearable ECG patch to detect new-onset episodes of atrial fibrillation. Thus the study also served as one of the first examples of a trial designed to examine whether a wearable, digital device can transform health care by improving clinical outcomes, an advance that crosses the current “chasm between the technology and clinical worlds,” wrote Eric D. Peterson, MD, and Robert A. Harrington, MD. Their editorial framed mSToPS as a breakthrough in a new type of information technology–based, pragmatic clinical trial (JAMA. 2018 July 10;320[2]:137-8).
Future trials with similar designs and novel health information technology methods could tap into the enormous information contained in electronic health records, wrote Dr. Peterson, a cardiologist, professor of medicine, and executive director of the Duke Clinical Research Institute at Duke University in Durham, N.C., and Dr. Harrington, a cardiologist, professor, and chairman of medicine at Stanford (Calif.) University.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Dr. Steven R. Steinhubl, lead investigator for the mSToPS trial, agreed with this assessment. Speaking in a video interview in March 2018 during the annual scientific sessions of the American College of Cardiology, where Dr. Steinhubl first reported the mSToPS results, he characterized the trial as “completely reimagining how clinical trials are done,” by making them less expensive and more convenient for participants. In this way, mSToPS is a break from the traditional randomized clinical trial format, which creates an “artificial treatment environment and artificial patient behaviors,” said Dr. Steinhubl, a cardiologist and director of digital medicine at the Scripps Translational Science Institute in La Jolla, Calif.
Dr. Peterson has received personal fees from Livogo and has received research funding from Akili, RefleXion Medical, and Verily Life Sciences. Dr. Harrington has been a consultant to Amgen, Element Science, Gilead Sciences, MyoKardia, and WebMD; has served on the board of directors of Signal Path and Scanadu; has received personal fees from Bayer; and has received research funding from Apple, AstraZeneca, Bristol-Myers Squibb, CSL, Janssen, Novartis, Portola, Sanofi, and the Medicines Company. Dr. Steinhubl has received research funding from Janssen, DynoSense, EasyG, SpryHealth, and Striiv.
SOURCE: Peterson ED et al. JAMA. 2018 July 10;320[2]:138-9.
The mSToPS study “represents an innovative example of the potential (and challenges) inherent in a pragmatic information technology trial. The trial “represents a brave new world for clinical research: an innovative, highly commendable, contemporary pragmatic health care information technology study that tested an important question and yielded significant clinical findings,” wrote two leaders in trial design in an editorial about the study.
In addition, the mHealth Screening to Prevent Strokes (mSToPS) trial tested the utility of a wearable ECG patch to detect new-onset episodes of atrial fibrillation. Thus the study also served as one of the first examples of a trial designed to examine whether a wearable, digital device can transform health care by improving clinical outcomes, an advance that crosses the current “chasm between the technology and clinical worlds,” wrote Eric D. Peterson, MD, and Robert A. Harrington, MD. Their editorial framed mSToPS as a breakthrough in a new type of information technology–based, pragmatic clinical trial (JAMA. 2018 July 10;320[2]:137-8).
Future trials with similar designs and novel health information technology methods could tap into the enormous information contained in electronic health records, wrote Dr. Peterson, a cardiologist, professor of medicine, and executive director of the Duke Clinical Research Institute at Duke University in Durham, N.C., and Dr. Harrington, a cardiologist, professor, and chairman of medicine at Stanford (Calif.) University.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Dr. Steven R. Steinhubl, lead investigator for the mSToPS trial, agreed with this assessment. Speaking in a video interview in March 2018 during the annual scientific sessions of the American College of Cardiology, where Dr. Steinhubl first reported the mSToPS results, he characterized the trial as “completely reimagining how clinical trials are done,” by making them less expensive and more convenient for participants. In this way, mSToPS is a break from the traditional randomized clinical trial format, which creates an “artificial treatment environment and artificial patient behaviors,” said Dr. Steinhubl, a cardiologist and director of digital medicine at the Scripps Translational Science Institute in La Jolla, Calif.
Dr. Peterson has received personal fees from Livogo and has received research funding from Akili, RefleXion Medical, and Verily Life Sciences. Dr. Harrington has been a consultant to Amgen, Element Science, Gilead Sciences, MyoKardia, and WebMD; has served on the board of directors of Signal Path and Scanadu; has received personal fees from Bayer; and has received research funding from Apple, AstraZeneca, Bristol-Myers Squibb, CSL, Janssen, Novartis, Portola, Sanofi, and the Medicines Company. Dr. Steinhubl has received research funding from Janssen, DynoSense, EasyG, SpryHealth, and Striiv.
SOURCE: Peterson ED et al. JAMA. 2018 July 10;320[2]:138-9.
The mSToPS study “represents an innovative example of the potential (and challenges) inherent in a pragmatic information technology trial. The trial “represents a brave new world for clinical research: an innovative, highly commendable, contemporary pragmatic health care information technology study that tested an important question and yielded significant clinical findings,” wrote two leaders in trial design in an editorial about the study.
In addition, the mHealth Screening to Prevent Strokes (mSToPS) trial tested the utility of a wearable ECG patch to detect new-onset episodes of atrial fibrillation. Thus the study also served as one of the first examples of a trial designed to examine whether a wearable, digital device can transform health care by improving clinical outcomes, an advance that crosses the current “chasm between the technology and clinical worlds,” wrote Eric D. Peterson, MD, and Robert A. Harrington, MD. Their editorial framed mSToPS as a breakthrough in a new type of information technology–based, pragmatic clinical trial (JAMA. 2018 July 10;320[2]:137-8).
Future trials with similar designs and novel health information technology methods could tap into the enormous information contained in electronic health records, wrote Dr. Peterson, a cardiologist, professor of medicine, and executive director of the Duke Clinical Research Institute at Duke University in Durham, N.C., and Dr. Harrington, a cardiologist, professor, and chairman of medicine at Stanford (Calif.) University.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Dr. Steven R. Steinhubl, lead investigator for the mSToPS trial, agreed with this assessment. Speaking in a video interview in March 2018 during the annual scientific sessions of the American College of Cardiology, where Dr. Steinhubl first reported the mSToPS results, he characterized the trial as “completely reimagining how clinical trials are done,” by making them less expensive and more convenient for participants. In this way, mSToPS is a break from the traditional randomized clinical trial format, which creates an “artificial treatment environment and artificial patient behaviors,” said Dr. Steinhubl, a cardiologist and director of digital medicine at the Scripps Translational Science Institute in La Jolla, Calif.
Dr. Peterson has received personal fees from Livogo and has received research funding from Akili, RefleXion Medical, and Verily Life Sciences. Dr. Harrington has been a consultant to Amgen, Element Science, Gilead Sciences, MyoKardia, and WebMD; has served on the board of directors of Signal Path and Scanadu; has received personal fees from Bayer; and has received research funding from Apple, AstraZeneca, Bristol-Myers Squibb, CSL, Janssen, Novartis, Portola, Sanofi, and the Medicines Company. Dr. Steinhubl has received research funding from Janssen, DynoSense, EasyG, SpryHealth, and Striiv.
SOURCE: Peterson ED et al. JAMA. 2018 July 10;320[2]:138-9.
FROM JAMA
Female authorship trends in academic gastroenterology over 4 decades
WASHINGTON – Gastroenterology is still a majority male specialty, although women are entering the field at higher and higher rates. Female first authorship tripled from 1995 to 2010 (from 11% to 32%) and female senior authorship tripled from 2000 to 2010 (from 7% to 24%), but gains have not been equal in all areas and have not continued in all areas.
Eileen J. Benz, MD, of Beaumont Hospital, Dublin, described in a video interview at the annual Digestive Disease Week® a study she and her colleagues conducted to analyze published research in the journal Gastroenterology for the changing prevalence of female authorship over 4 decades.
The researchers reviewed all research published in the January and July issues of Gastroenterology during 1971-2010 (865 abstracts); animal trials were excluded. The sex of the first author and the last author (considered the senior author) of each paper was recorded, as was the type of study (basic science, clinical trials, or epidemiologic research). The increase in female senior authorship lagged behind the increase in first authorship, which likely reflects the promotion of female gastroenterologists over time into senior academic positions.
Also noted was that basic science and epidemiology research have the highest number of female authors overall, and these areas seem to continue to add female authors, whereas the number of female authors in clinical trials research seems to have stagnated since 1996. Dr. Benz hypothesizes that both bench science and epidemiology have research time built in, but that for a physician who may have other demands on her time, clinical trials research is an add-on for which there may not be protected time.
WASHINGTON – Gastroenterology is still a majority male specialty, although women are entering the field at higher and higher rates. Female first authorship tripled from 1995 to 2010 (from 11% to 32%) and female senior authorship tripled from 2000 to 2010 (from 7% to 24%), but gains have not been equal in all areas and have not continued in all areas.
Eileen J. Benz, MD, of Beaumont Hospital, Dublin, described in a video interview at the annual Digestive Disease Week® a study she and her colleagues conducted to analyze published research in the journal Gastroenterology for the changing prevalence of female authorship over 4 decades.
The researchers reviewed all research published in the January and July issues of Gastroenterology during 1971-2010 (865 abstracts); animal trials were excluded. The sex of the first author and the last author (considered the senior author) of each paper was recorded, as was the type of study (basic science, clinical trials, or epidemiologic research). The increase in female senior authorship lagged behind the increase in first authorship, which likely reflects the promotion of female gastroenterologists over time into senior academic positions.
Also noted was that basic science and epidemiology research have the highest number of female authors overall, and these areas seem to continue to add female authors, whereas the number of female authors in clinical trials research seems to have stagnated since 1996. Dr. Benz hypothesizes that both bench science and epidemiology have research time built in, but that for a physician who may have other demands on her time, clinical trials research is an add-on for which there may not be protected time.
WASHINGTON – Gastroenterology is still a majority male specialty, although women are entering the field at higher and higher rates. Female first authorship tripled from 1995 to 2010 (from 11% to 32%) and female senior authorship tripled from 2000 to 2010 (from 7% to 24%), but gains have not been equal in all areas and have not continued in all areas.
Eileen J. Benz, MD, of Beaumont Hospital, Dublin, described in a video interview at the annual Digestive Disease Week® a study she and her colleagues conducted to analyze published research in the journal Gastroenterology for the changing prevalence of female authorship over 4 decades.
The researchers reviewed all research published in the January and July issues of Gastroenterology during 1971-2010 (865 abstracts); animal trials were excluded. The sex of the first author and the last author (considered the senior author) of each paper was recorded, as was the type of study (basic science, clinical trials, or epidemiologic research). The increase in female senior authorship lagged behind the increase in first authorship, which likely reflects the promotion of female gastroenterologists over time into senior academic positions.
Also noted was that basic science and epidemiology research have the highest number of female authors overall, and these areas seem to continue to add female authors, whereas the number of female authors in clinical trials research seems to have stagnated since 1996. Dr. Benz hypothesizes that both bench science and epidemiology have research time built in, but that for a physician who may have other demands on her time, clinical trials research is an add-on for which there may not be protected time.
Reporting from DDW 2018
Chronic kidney disease is 40% more common in T2DM than T1DM
ORLANDO – A new analysis of more than 1.5 million U.S. subjects with diabetes found that chronic kidney disease (CKD) is much more common in type 2 diabetes mellitus (T2DM) than in type 1 diabetes mellitus (T1DM) – 44% vs. 32%, respectively. The research also provides more evidence that albumin testing can provide crucial warning signs of future kidney trouble.
“Our data suggest – but don’t really prove – that there’s a lot more eGFR testing than there is albumin testing,” said nephrologist and study coauthor Michael Cressman, DO, of Covance, the drug development business of LabCorp, in an interview at the annual scientific sessions of the American Diabetes Association. “It is very important to measure albumin in the urine in order to identify patients who are at highest risk of progressive renal disease. There you identify people for whom you really want to maximize all the available treatments.”
According to the study, previous research has estimated that 25% of U.S. adults with diabetes have CKD (eGFR less than 60 ml/min per 1.73m2 or an albumin to creatinine ratio equal to or greater than 30 mg/g), but the difference in rates between T1DM and T2DM has been unclear.
Researchers analyzed LabCorp laboratory data on blood from for 48,036 adults with T1DM and 1,461,915 with T2DM. The analysis included ACR and CKD-EPI calculator for eGFR measurements from 2014-2017.
The researchers tracked declines in eGFR in patients who had more than three eGFR readings over at least 1 year.
Researchers found that the rate of CKD was 40% higher in patients with T2DM than it was in those with T1DM (44% vs. 32%, respectively; P less than .001), as was the prevalence of subjects considered to be at high or very high risk (18% vs. 12%, respectively; P less than .001).
These findings didn’t surprise Dr. Cressman, who said the higher ages of subjects with T2DM could explain the gap since they were more likely to have been exposed to hypertension for longer amounts of time.
Researchers also reported that the median eGFR decline (ml/min per year) was especially high in those with macroalbuminuria: –3.80 in T1DM and –3.58 in T2DM.
“Although MA [macroalbuminuria] is uncommon and most frequently observed in patients with normal or only mildly reduced eGFR, it was a potent predictor of eGFR decline in both T1DM and T2DM,” the researchers wrote.
“While it’s been known for a while that it’s bad to have albumin, this is more of a strong reinforcing piece of data,” Dr. Cressman said. “When you read about these things and it’s an epidemiological study or a clinical trial, it kind of loses its flavor. These are actual patients. A doctor could look at this data and say, ‘I ought to be checking this [albumin].’ It’s sort of an obvious rationale for what the guidelines say.”
No study funding was reported. Dr. Cressman reported employment by Covance. Other study authors variously report no disclosures or employment by Covance and its parent company LabCorp and stock/shareholding in LabCorp.
SOURCE: Cressman M et al. ADA 2018, Abstract 544-P.
ORLANDO – A new analysis of more than 1.5 million U.S. subjects with diabetes found that chronic kidney disease (CKD) is much more common in type 2 diabetes mellitus (T2DM) than in type 1 diabetes mellitus (T1DM) – 44% vs. 32%, respectively. The research also provides more evidence that albumin testing can provide crucial warning signs of future kidney trouble.
“Our data suggest – but don’t really prove – that there’s a lot more eGFR testing than there is albumin testing,” said nephrologist and study coauthor Michael Cressman, DO, of Covance, the drug development business of LabCorp, in an interview at the annual scientific sessions of the American Diabetes Association. “It is very important to measure albumin in the urine in order to identify patients who are at highest risk of progressive renal disease. There you identify people for whom you really want to maximize all the available treatments.”
According to the study, previous research has estimated that 25% of U.S. adults with diabetes have CKD (eGFR less than 60 ml/min per 1.73m2 or an albumin to creatinine ratio equal to or greater than 30 mg/g), but the difference in rates between T1DM and T2DM has been unclear.
Researchers analyzed LabCorp laboratory data on blood from for 48,036 adults with T1DM and 1,461,915 with T2DM. The analysis included ACR and CKD-EPI calculator for eGFR measurements from 2014-2017.
The researchers tracked declines in eGFR in patients who had more than three eGFR readings over at least 1 year.
Researchers found that the rate of CKD was 40% higher in patients with T2DM than it was in those with T1DM (44% vs. 32%, respectively; P less than .001), as was the prevalence of subjects considered to be at high or very high risk (18% vs. 12%, respectively; P less than .001).
These findings didn’t surprise Dr. Cressman, who said the higher ages of subjects with T2DM could explain the gap since they were more likely to have been exposed to hypertension for longer amounts of time.
Researchers also reported that the median eGFR decline (ml/min per year) was especially high in those with macroalbuminuria: –3.80 in T1DM and –3.58 in T2DM.
“Although MA [macroalbuminuria] is uncommon and most frequently observed in patients with normal or only mildly reduced eGFR, it was a potent predictor of eGFR decline in both T1DM and T2DM,” the researchers wrote.
“While it’s been known for a while that it’s bad to have albumin, this is more of a strong reinforcing piece of data,” Dr. Cressman said. “When you read about these things and it’s an epidemiological study or a clinical trial, it kind of loses its flavor. These are actual patients. A doctor could look at this data and say, ‘I ought to be checking this [albumin].’ It’s sort of an obvious rationale for what the guidelines say.”
No study funding was reported. Dr. Cressman reported employment by Covance. Other study authors variously report no disclosures or employment by Covance and its parent company LabCorp and stock/shareholding in LabCorp.
SOURCE: Cressman M et al. ADA 2018, Abstract 544-P.
ORLANDO – A new analysis of more than 1.5 million U.S. subjects with diabetes found that chronic kidney disease (CKD) is much more common in type 2 diabetes mellitus (T2DM) than in type 1 diabetes mellitus (T1DM) – 44% vs. 32%, respectively. The research also provides more evidence that albumin testing can provide crucial warning signs of future kidney trouble.
“Our data suggest – but don’t really prove – that there’s a lot more eGFR testing than there is albumin testing,” said nephrologist and study coauthor Michael Cressman, DO, of Covance, the drug development business of LabCorp, in an interview at the annual scientific sessions of the American Diabetes Association. “It is very important to measure albumin in the urine in order to identify patients who are at highest risk of progressive renal disease. There you identify people for whom you really want to maximize all the available treatments.”
According to the study, previous research has estimated that 25% of U.S. adults with diabetes have CKD (eGFR less than 60 ml/min per 1.73m2 or an albumin to creatinine ratio equal to or greater than 30 mg/g), but the difference in rates between T1DM and T2DM has been unclear.
Researchers analyzed LabCorp laboratory data on blood from for 48,036 adults with T1DM and 1,461,915 with T2DM. The analysis included ACR and CKD-EPI calculator for eGFR measurements from 2014-2017.
The researchers tracked declines in eGFR in patients who had more than three eGFR readings over at least 1 year.
Researchers found that the rate of CKD was 40% higher in patients with T2DM than it was in those with T1DM (44% vs. 32%, respectively; P less than .001), as was the prevalence of subjects considered to be at high or very high risk (18% vs. 12%, respectively; P less than .001).
These findings didn’t surprise Dr. Cressman, who said the higher ages of subjects with T2DM could explain the gap since they were more likely to have been exposed to hypertension for longer amounts of time.
Researchers also reported that the median eGFR decline (ml/min per year) was especially high in those with macroalbuminuria: –3.80 in T1DM and –3.58 in T2DM.
“Although MA [macroalbuminuria] is uncommon and most frequently observed in patients with normal or only mildly reduced eGFR, it was a potent predictor of eGFR decline in both T1DM and T2DM,” the researchers wrote.
“While it’s been known for a while that it’s bad to have albumin, this is more of a strong reinforcing piece of data,” Dr. Cressman said. “When you read about these things and it’s an epidemiological study or a clinical trial, it kind of loses its flavor. These are actual patients. A doctor could look at this data and say, ‘I ought to be checking this [albumin].’ It’s sort of an obvious rationale for what the guidelines say.”
No study funding was reported. Dr. Cressman reported employment by Covance. Other study authors variously report no disclosures or employment by Covance and its parent company LabCorp and stock/shareholding in LabCorp.
SOURCE: Cressman M et al. ADA 2018, Abstract 544-P.
REPORTING FROM ADA 2018
Key clinical point: CKD is significantly more common in patients with T2DM than those with T1DM, and albumin testing provides crucial warning signs.
Major finding: Of subjects with T2DM, 44% had signs of CKD, compared with 32% of those with T1DM.
Study details: Analysis of LabCorp blood testing of more than 1.5 million U.S. adults with diabetes from 2014-2017.
Disclosures: No study funding was reported. Authors reported various disclosures, mostly employment for Covance or its parent company, LabCorp.
Source: Cressman M et al. ADA 2018, Abstract 544-P.
Autism spectrum disorder in adults
EULAR recommendations on steroids: ‘As necessary, but as little as possible’
AMSTERDAM – Glucocorticosteroids remain an important therapeutic option for many patients with rheumatic and nonrheumatic disease, but careful assessment of their relative benefits and risks needs to be considered when prescribing, according to an expert summary of currently available European League Against Rheumatism (EULAR) recommendations.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
From rheumatoid arthritis (RA) and polymyalgia rheumatica (PMR) to vasculitis, myositis, and even gout, steroids are widely used in the rheumatic diseases, said Frank Buttgereit, MD, during a final plenary session at the European Congress of Rheumatology.
“These are strong-acting, rapidly acting, efficacious drugs,” observed Dr. Buttgereit, who is a professor in the department of rheumatology at Charité–Universitätsmedizin Berlin. While effective at reducing inflammation and providing immunosuppression, they are, of course, not without their well-known risks. Some of the well-documented risks he pointed out were the development of osteoporosis, myopathy, and edema; the disruption of lipid and carbohydrate metabolism; and the risk of developing glaucoma and cataracts.
“This leads to the question on how to optimize the use of these drugs,” Dr. Buttgereit said. “EULAR is constantly working to improve its guidelines,” and updating these in line with the available evidence, he added. “The bottom line is always give as much as necessary but as little as possible.”
Over the past few years, EULAR’s Glucocorticoid Task Force has been reviewing and updating recommendations on the use of these drugs and it has published several important documents clarifying their use in RA and in PMR. The task force has also published a viewpoint article on the long-term use of steroids, defining the conditions where an “acceptably low level of harm” might exist to enable their continued use. There have also been separate recommendations, published in 2010, on how to monitor these drugs (Ann Rheum Dis. 2010;69[11]:1913-9).
Clarifying the role of steroids in rheumatoid arthritis
The latest (2016) EULAR recommendations on the use of glucocorticosteroids were published last year (Ann Rheum Dis. 2017;76[6]:960-77) and included an important adjustment on when they should be initially used in RA, Dr. Buttgereit explained. Previous recommendations had said that steroids could be combined with disease-modifying antirheumatic drugs (DMARDs) but had suggested that they be used at a low dose. Now the wording has changed to focus on short-term use rather than dosing.
“Glucocorticoids can be given initially at different dosages, and using different routes of administration,” he said in a video interview at the EULAR Congress. The practice on what dose to give varies from country to country, he noted, so the recommendations are now being less prescriptive.
“We have made it clear that glucocorticoids should really be used only when initiating conventional synthetic DMARDs, but not necessarily if you switch to biologics or targeted synthetics because usually the onset of their actions is pretty fast,” Dr. Buttgereit said.
One thing that hasn’t changed is that steroid should be tapered down as “rapidly as clinically feasible” until, ideally, their full withdrawal. Although there are cases when that might not be possible, and their long-term use might be warranted. This is when you get into discussion about the benefit-to-risk ratio, he said.
Steroids for polymyalgia rheumatica
Steroids may be used as monotherapy in patients with PMR, Dr. Buttgereit observed, which is in contrast to other conditions such as RA. Although the evidence for use of steroids in PMR is limited, the EULAR Glucocorticoid Task Force and American College of Rheumatology recommended (Ann Rheum Dis. 2015;74[10]:1799-807) using a starting dose of a prednisolone-equivalent dose between 12.5 and 25 mg/day, and if there is an improvement in few weeks, the dose can start to be reduced. Tapering should be rapid at first to bring the dose down to 10 mg/day and followed by a more gradual dose-reduction phase.
“So, you can see we are giving more or less precise recommendations on how to start, how to taper,” Dr. Buttgereit said.
Balancing long-term benefit vs. harm
Balancing the long-term benefits and risks of steroids in rheumatic disease was the focus of a EULAR viewpoint article published 3 years ago in 2015 (Ann Rheum Dis. 2015;75[6]:952-7).
Three main messages can be drawn out of this work, Dr. Buttgereit said.
First, treatment with steroids for 3-6 months is associated with more benefits than risks if doses of 5 mg/day or less are used. There is one important exception to this, however, and that is the use of steroids in patients with comorbid cardiovascular disease.
Second, using doses of 10 mg/day for long periods tips the balance toward more risks than benefits, and “this means you should avoid this.”
Third, doses of 5-10 mg/day may be appropriate, but there are certain patient factors that will influence the benefit-to-harm ratio that need to be considered. These include older age, smoking, high alcohol consumption, and poor nutrition. There are also factors that may help protect the patients from risk, such as early diagnosis, low disease activity, low cumulative dose of steroids, and a shorter duration of treatment.
“It’s not only the dose, it’s also the absence or presence of risk factors and/or preventive measures,” that’s important, Dr. Buttgereit said.
Dr. Buttgereit has received consultancy fees, honoraria, and/or travel expenses from Amgen, Horizon Pharma, Mundipharma, Roche, and Pfizer and grant or study support from Amgen, Mundipharma, and Pfizer.
SOURCE: Buttgereit F. EULAR 2018 Congress, Abstract SP160.
AMSTERDAM – Glucocorticosteroids remain an important therapeutic option for many patients with rheumatic and nonrheumatic disease, but careful assessment of their relative benefits and risks needs to be considered when prescribing, according to an expert summary of currently available European League Against Rheumatism (EULAR) recommendations.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
From rheumatoid arthritis (RA) and polymyalgia rheumatica (PMR) to vasculitis, myositis, and even gout, steroids are widely used in the rheumatic diseases, said Frank Buttgereit, MD, during a final plenary session at the European Congress of Rheumatology.
“These are strong-acting, rapidly acting, efficacious drugs,” observed Dr. Buttgereit, who is a professor in the department of rheumatology at Charité–Universitätsmedizin Berlin. While effective at reducing inflammation and providing immunosuppression, they are, of course, not without their well-known risks. Some of the well-documented risks he pointed out were the development of osteoporosis, myopathy, and edema; the disruption of lipid and carbohydrate metabolism; and the risk of developing glaucoma and cataracts.
“This leads to the question on how to optimize the use of these drugs,” Dr. Buttgereit said. “EULAR is constantly working to improve its guidelines,” and updating these in line with the available evidence, he added. “The bottom line is always give as much as necessary but as little as possible.”
Over the past few years, EULAR’s Glucocorticoid Task Force has been reviewing and updating recommendations on the use of these drugs and it has published several important documents clarifying their use in RA and in PMR. The task force has also published a viewpoint article on the long-term use of steroids, defining the conditions where an “acceptably low level of harm” might exist to enable their continued use. There have also been separate recommendations, published in 2010, on how to monitor these drugs (Ann Rheum Dis. 2010;69[11]:1913-9).
Clarifying the role of steroids in rheumatoid arthritis
The latest (2016) EULAR recommendations on the use of glucocorticosteroids were published last year (Ann Rheum Dis. 2017;76[6]:960-77) and included an important adjustment on when they should be initially used in RA, Dr. Buttgereit explained. Previous recommendations had said that steroids could be combined with disease-modifying antirheumatic drugs (DMARDs) but had suggested that they be used at a low dose. Now the wording has changed to focus on short-term use rather than dosing.
“Glucocorticoids can be given initially at different dosages, and using different routes of administration,” he said in a video interview at the EULAR Congress. The practice on what dose to give varies from country to country, he noted, so the recommendations are now being less prescriptive.
“We have made it clear that glucocorticoids should really be used only when initiating conventional synthetic DMARDs, but not necessarily if you switch to biologics or targeted synthetics because usually the onset of their actions is pretty fast,” Dr. Buttgereit said.
One thing that hasn’t changed is that steroid should be tapered down as “rapidly as clinically feasible” until, ideally, their full withdrawal. Although there are cases when that might not be possible, and their long-term use might be warranted. This is when you get into discussion about the benefit-to-risk ratio, he said.
Steroids for polymyalgia rheumatica
Steroids may be used as monotherapy in patients with PMR, Dr. Buttgereit observed, which is in contrast to other conditions such as RA. Although the evidence for use of steroids in PMR is limited, the EULAR Glucocorticoid Task Force and American College of Rheumatology recommended (Ann Rheum Dis. 2015;74[10]:1799-807) using a starting dose of a prednisolone-equivalent dose between 12.5 and 25 mg/day, and if there is an improvement in few weeks, the dose can start to be reduced. Tapering should be rapid at first to bring the dose down to 10 mg/day and followed by a more gradual dose-reduction phase.
“So, you can see we are giving more or less precise recommendations on how to start, how to taper,” Dr. Buttgereit said.
Balancing long-term benefit vs. harm
Balancing the long-term benefits and risks of steroids in rheumatic disease was the focus of a EULAR viewpoint article published 3 years ago in 2015 (Ann Rheum Dis. 2015;75[6]:952-7).
Three main messages can be drawn out of this work, Dr. Buttgereit said.
First, treatment with steroids for 3-6 months is associated with more benefits than risks if doses of 5 mg/day or less are used. There is one important exception to this, however, and that is the use of steroids in patients with comorbid cardiovascular disease.
Second, using doses of 10 mg/day for long periods tips the balance toward more risks than benefits, and “this means you should avoid this.”
Third, doses of 5-10 mg/day may be appropriate, but there are certain patient factors that will influence the benefit-to-harm ratio that need to be considered. These include older age, smoking, high alcohol consumption, and poor nutrition. There are also factors that may help protect the patients from risk, such as early diagnosis, low disease activity, low cumulative dose of steroids, and a shorter duration of treatment.
“It’s not only the dose, it’s also the absence or presence of risk factors and/or preventive measures,” that’s important, Dr. Buttgereit said.
Dr. Buttgereit has received consultancy fees, honoraria, and/or travel expenses from Amgen, Horizon Pharma, Mundipharma, Roche, and Pfizer and grant or study support from Amgen, Mundipharma, and Pfizer.
SOURCE: Buttgereit F. EULAR 2018 Congress, Abstract SP160.
AMSTERDAM – Glucocorticosteroids remain an important therapeutic option for many patients with rheumatic and nonrheumatic disease, but careful assessment of their relative benefits and risks needs to be considered when prescribing, according to an expert summary of currently available European League Against Rheumatism (EULAR) recommendations.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
From rheumatoid arthritis (RA) and polymyalgia rheumatica (PMR) to vasculitis, myositis, and even gout, steroids are widely used in the rheumatic diseases, said Frank Buttgereit, MD, during a final plenary session at the European Congress of Rheumatology.
“These are strong-acting, rapidly acting, efficacious drugs,” observed Dr. Buttgereit, who is a professor in the department of rheumatology at Charité–Universitätsmedizin Berlin. While effective at reducing inflammation and providing immunosuppression, they are, of course, not without their well-known risks. Some of the well-documented risks he pointed out were the development of osteoporosis, myopathy, and edema; the disruption of lipid and carbohydrate metabolism; and the risk of developing glaucoma and cataracts.
“This leads to the question on how to optimize the use of these drugs,” Dr. Buttgereit said. “EULAR is constantly working to improve its guidelines,” and updating these in line with the available evidence, he added. “The bottom line is always give as much as necessary but as little as possible.”
Over the past few years, EULAR’s Glucocorticoid Task Force has been reviewing and updating recommendations on the use of these drugs and it has published several important documents clarifying their use in RA and in PMR. The task force has also published a viewpoint article on the long-term use of steroids, defining the conditions where an “acceptably low level of harm” might exist to enable their continued use. There have also been separate recommendations, published in 2010, on how to monitor these drugs (Ann Rheum Dis. 2010;69[11]:1913-9).
Clarifying the role of steroids in rheumatoid arthritis
The latest (2016) EULAR recommendations on the use of glucocorticosteroids were published last year (Ann Rheum Dis. 2017;76[6]:960-77) and included an important adjustment on when they should be initially used in RA, Dr. Buttgereit explained. Previous recommendations had said that steroids could be combined with disease-modifying antirheumatic drugs (DMARDs) but had suggested that they be used at a low dose. Now the wording has changed to focus on short-term use rather than dosing.
“Glucocorticoids can be given initially at different dosages, and using different routes of administration,” he said in a video interview at the EULAR Congress. The practice on what dose to give varies from country to country, he noted, so the recommendations are now being less prescriptive.
“We have made it clear that glucocorticoids should really be used only when initiating conventional synthetic DMARDs, but not necessarily if you switch to biologics or targeted synthetics because usually the onset of their actions is pretty fast,” Dr. Buttgereit said.
One thing that hasn’t changed is that steroid should be tapered down as “rapidly as clinically feasible” until, ideally, their full withdrawal. Although there are cases when that might not be possible, and their long-term use might be warranted. This is when you get into discussion about the benefit-to-risk ratio, he said.
Steroids for polymyalgia rheumatica
Steroids may be used as monotherapy in patients with PMR, Dr. Buttgereit observed, which is in contrast to other conditions such as RA. Although the evidence for use of steroids in PMR is limited, the EULAR Glucocorticoid Task Force and American College of Rheumatology recommended (Ann Rheum Dis. 2015;74[10]:1799-807) using a starting dose of a prednisolone-equivalent dose between 12.5 and 25 mg/day, and if there is an improvement in few weeks, the dose can start to be reduced. Tapering should be rapid at first to bring the dose down to 10 mg/day and followed by a more gradual dose-reduction phase.
“So, you can see we are giving more or less precise recommendations on how to start, how to taper,” Dr. Buttgereit said.
Balancing long-term benefit vs. harm
Balancing the long-term benefits and risks of steroids in rheumatic disease was the focus of a EULAR viewpoint article published 3 years ago in 2015 (Ann Rheum Dis. 2015;75[6]:952-7).
Three main messages can be drawn out of this work, Dr. Buttgereit said.
First, treatment with steroids for 3-6 months is associated with more benefits than risks if doses of 5 mg/day or less are used. There is one important exception to this, however, and that is the use of steroids in patients with comorbid cardiovascular disease.
Second, using doses of 10 mg/day for long periods tips the balance toward more risks than benefits, and “this means you should avoid this.”
Third, doses of 5-10 mg/day may be appropriate, but there are certain patient factors that will influence the benefit-to-harm ratio that need to be considered. These include older age, smoking, high alcohol consumption, and poor nutrition. There are also factors that may help protect the patients from risk, such as early diagnosis, low disease activity, low cumulative dose of steroids, and a shorter duration of treatment.
“It’s not only the dose, it’s also the absence or presence of risk factors and/or preventive measures,” that’s important, Dr. Buttgereit said.
Dr. Buttgereit has received consultancy fees, honoraria, and/or travel expenses from Amgen, Horizon Pharma, Mundipharma, Roche, and Pfizer and grant or study support from Amgen, Mundipharma, and Pfizer.
SOURCE: Buttgereit F. EULAR 2018 Congress, Abstract SP160.
REPORTING FROM THE EULAR 2018 CONGRESS
Key clinical point: When dosing glucocorticoids, give as much as necessary but as little as possible.
Major finding:
Disclosures: Dr. Buttgereit has received consultancy fees, honoraria, and/or travel expenses from Amgen, Horizon Pharma, Mundipharma, Roche, and Pfizer and grant or study support from Amgen, Mundipharma, and Pfizer.
Source: Buttgereit F. EULAR 2018 Congress. Abstract SP160.
Does expectant management or induction of labor at or beyond term result in better birth outcomes?
WHAT DOES THIS MEAN FOR PRACTICE?
- Induction of labor before 41 weeks’ gestation results in overall better outcomes in mother and newborn
Intensive treatment for T2D pays off in the long run
ORLANDO – Intensified multifactorial treatment proved cost effective over time in type 2 diabetes patients in the practice-changing Steno-2 study, according to 21-year follow-up data from the randomized Danish study.
Cumulative direct health care costs from the start of the trial in 1993 through 2014 were about $13 million in 24 patients in the intensive treatment group who were available for follow-up, and about $12.3 million in 42 patients in the conventional treatment group. The difference in costs between the groups was not statistically significant, Joachim Gaede reported at the annual scientific sessions of the American Diabetes Association.
Costs per patient-year during 1996-2014, however, were significantly lower in the intensive treatment group ($9,648 vs. $10, 681, respectively), said Mr. Gaede, a graduate student in the medicine program at the University of Copenhagen.
Furthermore, patients in the intensified treatment group lived a median of 7.9 years longer than did those who were in the conventional treatment group, suggesting that while costs might be higher early on, investing in early intensified treatment of all known modifiable risk factors in high-risk patients will prolong life and still save money over time thanks to reduced complication-related costs, he noted.
Steno-2 was an open, parallel group study initiated in 1993 to compare conventional multifactorial treatment of type 2 diabetes mellitus (T2DM) with an intensified approach over an 8-year period. Enrollment included 160 patients with high-risk type 2 diabetes. After the primary composite cardiovascular endpoint was assessed, the trial continued as an observational study, with all patients given the intensified, multifactorial treatment that consisted of lifestyle measures and medications targeting hyperglycemia, hypertension, hypercholesterolemia, and hypercoagulation.
Reports from the study over the years led to changes in treatment guidelines to promote more intensive multifactorial treatment, Mr. Gaede said. For example, the initial results reported in 1999 showed a 50% relative risk reduction in kidney, eye, and nerve complications after 4 years with intensive versus conventional treatment; a 2003 report showed a 53% relative risk reduction in MI, stroke, and amputation after 8 years; and a 2008 report demonstrated a 46% relative risk reduction in death after 13 years. Finally, in 2016 a 7.9-year gain in lifespan after 21 years with intensive versus conventional treatment was reported.
In this video interview, Mr. Gaede, junior lead study author, discusses the Steno-2 study findings and the current cost analysis data.
“The bottom line is that ... you can actually, as a patient, be treated at a specialized diabetes clinic ... and, in the long run, it doesn’t cost you anything” more, he said, explaining that the up-front costs of intensive treatment are offset by the money saved because of the reduced complications over time.
Mr. Gaede reported having no disclosures.
SOURCE: Gaede J et al. ADA 2018, Abstract 162-OR.
ORLANDO – Intensified multifactorial treatment proved cost effective over time in type 2 diabetes patients in the practice-changing Steno-2 study, according to 21-year follow-up data from the randomized Danish study.
Cumulative direct health care costs from the start of the trial in 1993 through 2014 were about $13 million in 24 patients in the intensive treatment group who were available for follow-up, and about $12.3 million in 42 patients in the conventional treatment group. The difference in costs between the groups was not statistically significant, Joachim Gaede reported at the annual scientific sessions of the American Diabetes Association.
Costs per patient-year during 1996-2014, however, were significantly lower in the intensive treatment group ($9,648 vs. $10, 681, respectively), said Mr. Gaede, a graduate student in the medicine program at the University of Copenhagen.
Furthermore, patients in the intensified treatment group lived a median of 7.9 years longer than did those who were in the conventional treatment group, suggesting that while costs might be higher early on, investing in early intensified treatment of all known modifiable risk factors in high-risk patients will prolong life and still save money over time thanks to reduced complication-related costs, he noted.
Steno-2 was an open, parallel group study initiated in 1993 to compare conventional multifactorial treatment of type 2 diabetes mellitus (T2DM) with an intensified approach over an 8-year period. Enrollment included 160 patients with high-risk type 2 diabetes. After the primary composite cardiovascular endpoint was assessed, the trial continued as an observational study, with all patients given the intensified, multifactorial treatment that consisted of lifestyle measures and medications targeting hyperglycemia, hypertension, hypercholesterolemia, and hypercoagulation.
Reports from the study over the years led to changes in treatment guidelines to promote more intensive multifactorial treatment, Mr. Gaede said. For example, the initial results reported in 1999 showed a 50% relative risk reduction in kidney, eye, and nerve complications after 4 years with intensive versus conventional treatment; a 2003 report showed a 53% relative risk reduction in MI, stroke, and amputation after 8 years; and a 2008 report demonstrated a 46% relative risk reduction in death after 13 years. Finally, in 2016 a 7.9-year gain in lifespan after 21 years with intensive versus conventional treatment was reported.
In this video interview, Mr. Gaede, junior lead study author, discusses the Steno-2 study findings and the current cost analysis data.
“The bottom line is that ... you can actually, as a patient, be treated at a specialized diabetes clinic ... and, in the long run, it doesn’t cost you anything” more, he said, explaining that the up-front costs of intensive treatment are offset by the money saved because of the reduced complications over time.
Mr. Gaede reported having no disclosures.
SOURCE: Gaede J et al. ADA 2018, Abstract 162-OR.
ORLANDO – Intensified multifactorial treatment proved cost effective over time in type 2 diabetes patients in the practice-changing Steno-2 study, according to 21-year follow-up data from the randomized Danish study.
Cumulative direct health care costs from the start of the trial in 1993 through 2014 were about $13 million in 24 patients in the intensive treatment group who were available for follow-up, and about $12.3 million in 42 patients in the conventional treatment group. The difference in costs between the groups was not statistically significant, Joachim Gaede reported at the annual scientific sessions of the American Diabetes Association.
Costs per patient-year during 1996-2014, however, were significantly lower in the intensive treatment group ($9,648 vs. $10, 681, respectively), said Mr. Gaede, a graduate student in the medicine program at the University of Copenhagen.
Furthermore, patients in the intensified treatment group lived a median of 7.9 years longer than did those who were in the conventional treatment group, suggesting that while costs might be higher early on, investing in early intensified treatment of all known modifiable risk factors in high-risk patients will prolong life and still save money over time thanks to reduced complication-related costs, he noted.
Steno-2 was an open, parallel group study initiated in 1993 to compare conventional multifactorial treatment of type 2 diabetes mellitus (T2DM) with an intensified approach over an 8-year period. Enrollment included 160 patients with high-risk type 2 diabetes. After the primary composite cardiovascular endpoint was assessed, the trial continued as an observational study, with all patients given the intensified, multifactorial treatment that consisted of lifestyle measures and medications targeting hyperglycemia, hypertension, hypercholesterolemia, and hypercoagulation.
Reports from the study over the years led to changes in treatment guidelines to promote more intensive multifactorial treatment, Mr. Gaede said. For example, the initial results reported in 1999 showed a 50% relative risk reduction in kidney, eye, and nerve complications after 4 years with intensive versus conventional treatment; a 2003 report showed a 53% relative risk reduction in MI, stroke, and amputation after 8 years; and a 2008 report demonstrated a 46% relative risk reduction in death after 13 years. Finally, in 2016 a 7.9-year gain in lifespan after 21 years with intensive versus conventional treatment was reported.
In this video interview, Mr. Gaede, junior lead study author, discusses the Steno-2 study findings and the current cost analysis data.
“The bottom line is that ... you can actually, as a patient, be treated at a specialized diabetes clinic ... and, in the long run, it doesn’t cost you anything” more, he said, explaining that the up-front costs of intensive treatment are offset by the money saved because of the reduced complications over time.
Mr. Gaede reported having no disclosures.
SOURCE: Gaede J et al. ADA 2018, Abstract 162-OR.
REPORTING FROM ADA 2018
Salivary gland ultrasound is accurate diagnostic tool for Sjögren’s
AMSTERDAM – Ultrasound of the salivary glands is a readily available and inexpensive tool for the diagnosis of Sjögren’s syndrome, according to a study that evaluated this test in relation to the recent American College of Rheumatology and European League Against Rheumatism (ACR/EULAR) classification criteria.
In a video interview, Esther-Jellina Mossel reported that the sensitivity and specificity of a Sjögren’s syndrome diagnosis is essentially unchanged when ultrasound replaces a positive ocular staining score, the Schirmer test, or an unstimulated whole saliva flow test, without reducing diagnostic accuracy.
The sensitivity of the diagnosis is reduced only if ultrasound is used to replace either of the two remaining ACR/EULAR criteria, which are a labial gland biopsy or an anti-SSA antibody test. In relation to the three criteria that it can replace without loss of diagnostic accuracy, ultrasound might have advantages.
“People who don’t have access to an ophthalmologist performing an ocular staining score, for instance, could use an ultrasound of the salivary glands instead of the ocular staining score and still make a diagnosis,” said Ms. Mossel, a PhD student in the department of rheumatology at the University of Groningen (the Netherlands).
Ultrasound, which is commonly used to evaluate joints of patients with inflammatory diseases, is available in the offices of most rheumatologists, according to Ms. Mossel. She estimated that the evaluation of the salivary glands, which reveals characteristic hypoechogenic areas when Sjögren’s syndrome is present, takes about 10 minutes.
At Ms. Mossel’s center, ultrasound has already become a standard tool for the diagnosis of Sjögren’s syndrome. She said that other centers have also found this imaging tool to be accurate and useful for Sjögren’s syndrome diagnosis.
Based on the experience at the University of Groningen, Ms. Mossel believes that ultrasound will eventually be widely adopted for Sjögren’s syndrome diagnosis. Indeed, she expects that this strategy is likely to be added to the ACR/EULAR diagnostic criteria when its accuracy becomes more generally recognized.
AMSTERDAM – Ultrasound of the salivary glands is a readily available and inexpensive tool for the diagnosis of Sjögren’s syndrome, according to a study that evaluated this test in relation to the recent American College of Rheumatology and European League Against Rheumatism (ACR/EULAR) classification criteria.
In a video interview, Esther-Jellina Mossel reported that the sensitivity and specificity of a Sjögren’s syndrome diagnosis is essentially unchanged when ultrasound replaces a positive ocular staining score, the Schirmer test, or an unstimulated whole saliva flow test, without reducing diagnostic accuracy.
The sensitivity of the diagnosis is reduced only if ultrasound is used to replace either of the two remaining ACR/EULAR criteria, which are a labial gland biopsy or an anti-SSA antibody test. In relation to the three criteria that it can replace without loss of diagnostic accuracy, ultrasound might have advantages.
“People who don’t have access to an ophthalmologist performing an ocular staining score, for instance, could use an ultrasound of the salivary glands instead of the ocular staining score and still make a diagnosis,” said Ms. Mossel, a PhD student in the department of rheumatology at the University of Groningen (the Netherlands).
Ultrasound, which is commonly used to evaluate joints of patients with inflammatory diseases, is available in the offices of most rheumatologists, according to Ms. Mossel. She estimated that the evaluation of the salivary glands, which reveals characteristic hypoechogenic areas when Sjögren’s syndrome is present, takes about 10 minutes.
At Ms. Mossel’s center, ultrasound has already become a standard tool for the diagnosis of Sjögren’s syndrome. She said that other centers have also found this imaging tool to be accurate and useful for Sjögren’s syndrome diagnosis.
Based on the experience at the University of Groningen, Ms. Mossel believes that ultrasound will eventually be widely adopted for Sjögren’s syndrome diagnosis. Indeed, she expects that this strategy is likely to be added to the ACR/EULAR diagnostic criteria when its accuracy becomes more generally recognized.
AMSTERDAM – Ultrasound of the salivary glands is a readily available and inexpensive tool for the diagnosis of Sjögren’s syndrome, according to a study that evaluated this test in relation to the recent American College of Rheumatology and European League Against Rheumatism (ACR/EULAR) classification criteria.
In a video interview, Esther-Jellina Mossel reported that the sensitivity and specificity of a Sjögren’s syndrome diagnosis is essentially unchanged when ultrasound replaces a positive ocular staining score, the Schirmer test, or an unstimulated whole saliva flow test, without reducing diagnostic accuracy.
The sensitivity of the diagnosis is reduced only if ultrasound is used to replace either of the two remaining ACR/EULAR criteria, which are a labial gland biopsy or an anti-SSA antibody test. In relation to the three criteria that it can replace without loss of diagnostic accuracy, ultrasound might have advantages.
“People who don’t have access to an ophthalmologist performing an ocular staining score, for instance, could use an ultrasound of the salivary glands instead of the ocular staining score and still make a diagnosis,” said Ms. Mossel, a PhD student in the department of rheumatology at the University of Groningen (the Netherlands).
Ultrasound, which is commonly used to evaluate joints of patients with inflammatory diseases, is available in the offices of most rheumatologists, according to Ms. Mossel. She estimated that the evaluation of the salivary glands, which reveals characteristic hypoechogenic areas when Sjögren’s syndrome is present, takes about 10 minutes.
At Ms. Mossel’s center, ultrasound has already become a standard tool for the diagnosis of Sjögren’s syndrome. She said that other centers have also found this imaging tool to be accurate and useful for Sjögren’s syndrome diagnosis.
Based on the experience at the University of Groningen, Ms. Mossel believes that ultrasound will eventually be widely adopted for Sjögren’s syndrome diagnosis. Indeed, she expects that this strategy is likely to be added to the ACR/EULAR diagnostic criteria when its accuracy becomes more generally recognized.
REPORTING FROM THE EULAR 2018 CONGRESS
