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Diabetes Hub contains news and clinical review articles for physicians seeking the most up-to-date information on the rapidly evolving options for treating and preventing Type 2 Diabetes in at-risk patients. The Diabetes Hub is powered by Frontline Medical Communications.
No clear choice for vision treatment for diabetic macular edema
Aflibercept was more effective for vision treatment in patients with diabetic macular edema then were two other vascular endothelial growth factor inhibitors, bevacizumab and ranibizumab, but only in patients with poor baseline vision, according to Adam Glassman and his associates.
When baseline vision was worse than roughly 20/50, aflibercept improved vision by an average of 19%, compared to 12% with bevacizumab and 14% with ranibizumab. When the initial vision impairment was more mild, all three performed at about the same level. For patients with vision between 20/30 and 20/40, all three drugs improved vision by about 8%. For all patients, aflibercept improved vision by 13%, bevacizumab improved vision by 10%, and ranibizumab improved vision by 11%.
No significant differences in the incidence of serious adverse side effects, hospitalization, major cardiovascular events, or death were found among the three groups, the investigators reported.
Find the full study in the New England Journal of Medicine (doi: 10.1056/NEJMoa1414264).
Aflibercept was more effective for vision treatment in patients with diabetic macular edema then were two other vascular endothelial growth factor inhibitors, bevacizumab and ranibizumab, but only in patients with poor baseline vision, according to Adam Glassman and his associates.
When baseline vision was worse than roughly 20/50, aflibercept improved vision by an average of 19%, compared to 12% with bevacizumab and 14% with ranibizumab. When the initial vision impairment was more mild, all three performed at about the same level. For patients with vision between 20/30 and 20/40, all three drugs improved vision by about 8%. For all patients, aflibercept improved vision by 13%, bevacizumab improved vision by 10%, and ranibizumab improved vision by 11%.
No significant differences in the incidence of serious adverse side effects, hospitalization, major cardiovascular events, or death were found among the three groups, the investigators reported.
Find the full study in the New England Journal of Medicine (doi: 10.1056/NEJMoa1414264).
Aflibercept was more effective for vision treatment in patients with diabetic macular edema then were two other vascular endothelial growth factor inhibitors, bevacizumab and ranibizumab, but only in patients with poor baseline vision, according to Adam Glassman and his associates.
When baseline vision was worse than roughly 20/50, aflibercept improved vision by an average of 19%, compared to 12% with bevacizumab and 14% with ranibizumab. When the initial vision impairment was more mild, all three performed at about the same level. For patients with vision between 20/30 and 20/40, all three drugs improved vision by about 8%. For all patients, aflibercept improved vision by 13%, bevacizumab improved vision by 10%, and ranibizumab improved vision by 11%.
No significant differences in the incidence of serious adverse side effects, hospitalization, major cardiovascular events, or death were found among the three groups, the investigators reported.
Find the full study in the New England Journal of Medicine (doi: 10.1056/NEJMoa1414264).
Ranibizumab now approved for diabetic retinopathy with macular edema
Ranibizumab, a vascular endothelial growth factor, or VEGF inhibitor, has been approved to treat diabetic retinopathy in patients with diabetic macular edema, the Food and Drug Administration announced on Feb 6.
This approval “gives patients with diabetic retinopathy and diabetic macular edema the first significant therapy to treat this vision-impairing complication,” Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in the statement. A 0.3-mg dose is administered by intravitreal injection once a month (roughly every 28 days), according to the updated prescribing information.
Approval was based on two studies of 759 patients, which found that after 2 years of treatment, those treated with ranibizumab had significant improvements in the severity of diabetic retinopathy, compared with controls. Bleeding of the conjunctiva, eye pain, floaters, and increased intraocular pressure were the most common adverse effects associated with treatment; endophthalmitis and retinal detachments were the most serious adverse effects, according to the FDA.
Ranibizumab was first approved in 2006, for neovascular (wet) age-related macular degeneration, followed by diabetic macular edema, and macular edema following retinal vein occlusion. It is marketed as Lucentis, by Genentech, a member of the Roche group. “The binding of ranibizumab to VEGF-A prevents the interaction of VEGF-A with its receptors (VEGFR1 and VEGFR2) on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation,” according to the prescribing information.
Ranibizumab, a vascular endothelial growth factor, or VEGF inhibitor, has been approved to treat diabetic retinopathy in patients with diabetic macular edema, the Food and Drug Administration announced on Feb 6.
This approval “gives patients with diabetic retinopathy and diabetic macular edema the first significant therapy to treat this vision-impairing complication,” Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in the statement. A 0.3-mg dose is administered by intravitreal injection once a month (roughly every 28 days), according to the updated prescribing information.
Approval was based on two studies of 759 patients, which found that after 2 years of treatment, those treated with ranibizumab had significant improvements in the severity of diabetic retinopathy, compared with controls. Bleeding of the conjunctiva, eye pain, floaters, and increased intraocular pressure were the most common adverse effects associated with treatment; endophthalmitis and retinal detachments were the most serious adverse effects, according to the FDA.
Ranibizumab was first approved in 2006, for neovascular (wet) age-related macular degeneration, followed by diabetic macular edema, and macular edema following retinal vein occlusion. It is marketed as Lucentis, by Genentech, a member of the Roche group. “The binding of ranibizumab to VEGF-A prevents the interaction of VEGF-A with its receptors (VEGFR1 and VEGFR2) on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation,” according to the prescribing information.
Ranibizumab, a vascular endothelial growth factor, or VEGF inhibitor, has been approved to treat diabetic retinopathy in patients with diabetic macular edema, the Food and Drug Administration announced on Feb 6.
This approval “gives patients with diabetic retinopathy and diabetic macular edema the first significant therapy to treat this vision-impairing complication,” Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in the statement. A 0.3-mg dose is administered by intravitreal injection once a month (roughly every 28 days), according to the updated prescribing information.
Approval was based on two studies of 759 patients, which found that after 2 years of treatment, those treated with ranibizumab had significant improvements in the severity of diabetic retinopathy, compared with controls. Bleeding of the conjunctiva, eye pain, floaters, and increased intraocular pressure were the most common adverse effects associated with treatment; endophthalmitis and retinal detachments were the most serious adverse effects, according to the FDA.
Ranibizumab was first approved in 2006, for neovascular (wet) age-related macular degeneration, followed by diabetic macular edema, and macular edema following retinal vein occlusion. It is marketed as Lucentis, by Genentech, a member of the Roche group. “The binding of ranibizumab to VEGF-A prevents the interaction of VEGF-A with its receptors (VEGFR1 and VEGFR2) on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation,” according to the prescribing information.
No increased pancreatitis risk found with incretin therapy
No association between an increased risk of acute pancreatitis and treatment with incretin therapy for type 2 diabetes was found in a large case control-study.
To evaluate whether the risk of acute pancreatitis was increased among patients treated with incretin-based drugs – glucagonlike peptide–1 (GLP-1) receptor agonists and dipeptidyl peptidase–4 (DPP-4) inhibitors – the investigators compared the risks of acute pancreatitis associated with different antihyperglycemic drugs in 12,868 people hospitalized for the first time for acute pancreatitis, and in 12,680 controls matched for birth year, sex, and region of residence in Denmark.
The study addressed evidence indicating that incretins may cause pancreatitis and pancreatic cancer in humans, which includes adverse event reports suggesting a signal of pancreatitis, but the association between incretins and acute pancreatitis is controversial and is an issue that “remains under debate,” they noted.
The data used were from three Danish databases, including one of reimbursed prescriptions. After adjustment for comorbidities and drugs associated with pancreatitis, including alcoholism and obesity, the risk of acute pancreatitis was not increased among those who had ever used an incretin, with an odds ratio of 0.95, according to Dr. Reimar Thomsen of the department of clinical epidemiology, Institute of Clinical Medicine, Aarhus (Denmark) University Hospital, and his associates (Diabetes Care 2015 [doi:10.2337/dc13-2983])
Risk was also not increased among those who had been ever treated with a DPP-4 inhibitor (OR, 1.04), which included an OR of 1.06 for sitagliptin, or among those who had been treated with a GLP-1 receptor agonist (OR, 0.82), which included an OR of 0.75 for liraglutide. Nor was risk elevated among those treated with nonincretin antihyperglycemic drugs (OR, 1.05).
In addition, the adjusted odds ratio comparing the risk of acute pancreatitis associated with incretin treatments and other antihyperglycemics was not increased, approaching 1.
The crude odds ratios, before adjustment for confounding factors, was 1.36 in patients who had been treated with incretins and 1.44 among those who had been treated with other antihyperglycemic drugs. “The fact that crude ORs were increased to very similar levels for all antihyperglycemic drugs – given their different modes of action – points to a general underlying diabetes effect on pancreatitis risk, rather than a specific drug effect,” they commented. In the crude analyses, they determined that obesity, gallstones, and other diabetes-related risk factors “may explain much of the apparent risk increase,” the investigators added.
Other findings included an increased risk of acute pancreatitis among those who had recently started treatment with a DPP-4 inhibitor and in those who had recently started treatment with several other antihyperglycemic drugs, including sulfonylureas and insulin. “This lack of specificity suggests that either the increased pancreatitis risk is related to newly diagnosed and drug-treated type 2 diabetes per se, with a possibility of reverse causality due to pancreatogenic diabetes,” or that starting therapy with sulfonylureas and insulin “also causes acute pancreatitis, which should be further investigated,” they said.
Incretin-based drugs include injectable incretin mimetic agents (GLP-1 receptor agonists) such as liraglutide; and incretin enhancers (DPP-4) inhibitors, such as sitagliptin.
The study was supported by the Clinical Epidemiological Research Foundation in Denmark. One of the authors, from the Danish Center for Strategic Research in Type 2 Diabetes, at Odense University Hospital, disclosed having received research grants form Novo-Nordisk. Of the six authors, four are from the Aarhus University Hospital clinical epidemiology department, a member of the center, which receives funding that includes an unrestricted donation from Novo-Nordisk.
No association between an increased risk of acute pancreatitis and treatment with incretin therapy for type 2 diabetes was found in a large case control-study.
To evaluate whether the risk of acute pancreatitis was increased among patients treated with incretin-based drugs – glucagonlike peptide–1 (GLP-1) receptor agonists and dipeptidyl peptidase–4 (DPP-4) inhibitors – the investigators compared the risks of acute pancreatitis associated with different antihyperglycemic drugs in 12,868 people hospitalized for the first time for acute pancreatitis, and in 12,680 controls matched for birth year, sex, and region of residence in Denmark.
The study addressed evidence indicating that incretins may cause pancreatitis and pancreatic cancer in humans, which includes adverse event reports suggesting a signal of pancreatitis, but the association between incretins and acute pancreatitis is controversial and is an issue that “remains under debate,” they noted.
The data used were from three Danish databases, including one of reimbursed prescriptions. After adjustment for comorbidities and drugs associated with pancreatitis, including alcoholism and obesity, the risk of acute pancreatitis was not increased among those who had ever used an incretin, with an odds ratio of 0.95, according to Dr. Reimar Thomsen of the department of clinical epidemiology, Institute of Clinical Medicine, Aarhus (Denmark) University Hospital, and his associates (Diabetes Care 2015 [doi:10.2337/dc13-2983])
Risk was also not increased among those who had been ever treated with a DPP-4 inhibitor (OR, 1.04), which included an OR of 1.06 for sitagliptin, or among those who had been treated with a GLP-1 receptor agonist (OR, 0.82), which included an OR of 0.75 for liraglutide. Nor was risk elevated among those treated with nonincretin antihyperglycemic drugs (OR, 1.05).
In addition, the adjusted odds ratio comparing the risk of acute pancreatitis associated with incretin treatments and other antihyperglycemics was not increased, approaching 1.
The crude odds ratios, before adjustment for confounding factors, was 1.36 in patients who had been treated with incretins and 1.44 among those who had been treated with other antihyperglycemic drugs. “The fact that crude ORs were increased to very similar levels for all antihyperglycemic drugs – given their different modes of action – points to a general underlying diabetes effect on pancreatitis risk, rather than a specific drug effect,” they commented. In the crude analyses, they determined that obesity, gallstones, and other diabetes-related risk factors “may explain much of the apparent risk increase,” the investigators added.
Other findings included an increased risk of acute pancreatitis among those who had recently started treatment with a DPP-4 inhibitor and in those who had recently started treatment with several other antihyperglycemic drugs, including sulfonylureas and insulin. “This lack of specificity suggests that either the increased pancreatitis risk is related to newly diagnosed and drug-treated type 2 diabetes per se, with a possibility of reverse causality due to pancreatogenic diabetes,” or that starting therapy with sulfonylureas and insulin “also causes acute pancreatitis, which should be further investigated,” they said.
Incretin-based drugs include injectable incretin mimetic agents (GLP-1 receptor agonists) such as liraglutide; and incretin enhancers (DPP-4) inhibitors, such as sitagliptin.
The study was supported by the Clinical Epidemiological Research Foundation in Denmark. One of the authors, from the Danish Center for Strategic Research in Type 2 Diabetes, at Odense University Hospital, disclosed having received research grants form Novo-Nordisk. Of the six authors, four are from the Aarhus University Hospital clinical epidemiology department, a member of the center, which receives funding that includes an unrestricted donation from Novo-Nordisk.
No association between an increased risk of acute pancreatitis and treatment with incretin therapy for type 2 diabetes was found in a large case control-study.
To evaluate whether the risk of acute pancreatitis was increased among patients treated with incretin-based drugs – glucagonlike peptide–1 (GLP-1) receptor agonists and dipeptidyl peptidase–4 (DPP-4) inhibitors – the investigators compared the risks of acute pancreatitis associated with different antihyperglycemic drugs in 12,868 people hospitalized for the first time for acute pancreatitis, and in 12,680 controls matched for birth year, sex, and region of residence in Denmark.
The study addressed evidence indicating that incretins may cause pancreatitis and pancreatic cancer in humans, which includes adverse event reports suggesting a signal of pancreatitis, but the association between incretins and acute pancreatitis is controversial and is an issue that “remains under debate,” they noted.
The data used were from three Danish databases, including one of reimbursed prescriptions. After adjustment for comorbidities and drugs associated with pancreatitis, including alcoholism and obesity, the risk of acute pancreatitis was not increased among those who had ever used an incretin, with an odds ratio of 0.95, according to Dr. Reimar Thomsen of the department of clinical epidemiology, Institute of Clinical Medicine, Aarhus (Denmark) University Hospital, and his associates (Diabetes Care 2015 [doi:10.2337/dc13-2983])
Risk was also not increased among those who had been ever treated with a DPP-4 inhibitor (OR, 1.04), which included an OR of 1.06 for sitagliptin, or among those who had been treated with a GLP-1 receptor agonist (OR, 0.82), which included an OR of 0.75 for liraglutide. Nor was risk elevated among those treated with nonincretin antihyperglycemic drugs (OR, 1.05).
In addition, the adjusted odds ratio comparing the risk of acute pancreatitis associated with incretin treatments and other antihyperglycemics was not increased, approaching 1.
The crude odds ratios, before adjustment for confounding factors, was 1.36 in patients who had been treated with incretins and 1.44 among those who had been treated with other antihyperglycemic drugs. “The fact that crude ORs were increased to very similar levels for all antihyperglycemic drugs – given their different modes of action – points to a general underlying diabetes effect on pancreatitis risk, rather than a specific drug effect,” they commented. In the crude analyses, they determined that obesity, gallstones, and other diabetes-related risk factors “may explain much of the apparent risk increase,” the investigators added.
Other findings included an increased risk of acute pancreatitis among those who had recently started treatment with a DPP-4 inhibitor and in those who had recently started treatment with several other antihyperglycemic drugs, including sulfonylureas and insulin. “This lack of specificity suggests that either the increased pancreatitis risk is related to newly diagnosed and drug-treated type 2 diabetes per se, with a possibility of reverse causality due to pancreatogenic diabetes,” or that starting therapy with sulfonylureas and insulin “also causes acute pancreatitis, which should be further investigated,” they said.
Incretin-based drugs include injectable incretin mimetic agents (GLP-1 receptor agonists) such as liraglutide; and incretin enhancers (DPP-4) inhibitors, such as sitagliptin.
The study was supported by the Clinical Epidemiological Research Foundation in Denmark. One of the authors, from the Danish Center for Strategic Research in Type 2 Diabetes, at Odense University Hospital, disclosed having received research grants form Novo-Nordisk. Of the six authors, four are from the Aarhus University Hospital clinical epidemiology department, a member of the center, which receives funding that includes an unrestricted donation from Novo-Nordisk.
Key clinical point: Neither GLP-1 receptor agonists nor DPP-4 inhibitors increase the risk of acute pancreatitis in type 2 diabetes patients.
Major finding: The risk of acute pancreatitis was not increased among Danes who had been treated with an incretin drug (odds ratio, 0.95), after adjustment for comorbidities and medications that can increase risk.
Data source: A population-based case-control study in 12,868 patients hospitalized for the first time with acute pancreatitis between 2005 and 2012, matched with 128,680 controls, from national medical databases.
Disclosures: The study was supported by the Clinical Epidemiological Research Foundation in Denmark. Most of the authors are at Danish institutions that receive funding and grants from Novo-Nordisk.
VIDEO: No consensus on diagnostic criteria for gestational diabetes
SAN DIEGO – A lack of consensus exists regarding optimal criteria for diagnosing gestational diabetes mellitus, noted Dr. Linda Barbour.
“The biggest question is, if we are to diagnose many more women and increase the prevalence [of gestational diabetes mellitus] by two- to threefold by diagnosing them and treating them, will we see improved outcomes?” asked Dr. Barbour, professor of medicine and obstetrics and gynecology at the University of Colorado, Aurora.
In an interview at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine, Dr. Barbour discussed the challenges that have prevented a consensus from emerging.
She reported having no financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @dougbrunk
SAN DIEGO – A lack of consensus exists regarding optimal criteria for diagnosing gestational diabetes mellitus, noted Dr. Linda Barbour.
“The biggest question is, if we are to diagnose many more women and increase the prevalence [of gestational diabetes mellitus] by two- to threefold by diagnosing them and treating them, will we see improved outcomes?” asked Dr. Barbour, professor of medicine and obstetrics and gynecology at the University of Colorado, Aurora.
In an interview at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine, Dr. Barbour discussed the challenges that have prevented a consensus from emerging.
She reported having no financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @dougbrunk
SAN DIEGO – A lack of consensus exists regarding optimal criteria for diagnosing gestational diabetes mellitus, noted Dr. Linda Barbour.
“The biggest question is, if we are to diagnose many more women and increase the prevalence [of gestational diabetes mellitus] by two- to threefold by diagnosing them and treating them, will we see improved outcomes?” asked Dr. Barbour, professor of medicine and obstetrics and gynecology at the University of Colorado, Aurora.
In an interview at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine, Dr. Barbour discussed the challenges that have prevented a consensus from emerging.
She reported having no financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @dougbrunk
AT THE PREGNANCY MEETING
Early prediabetes treatment reduces HbA1C during pregnancy
SAN DIEGO– Early treatment of pregnant women with prediabetes led to lower hemoglobin A1C (HbA1C) levels during the second trimester and at delivery in a randomized, controlled trial.
Study subjects were 83 women with a first trimester HbA1C of 5.7%-6.4% (median of 5.8%) indicative of prediabetes. HbA1C levels during the second trimester were 5.2% and 5.3% in the 42 women who were randomized to receive early treatment and in the 41 who received routine care, respectively, and the levels at delivery were 5.5% and 5.8%, respectively, Dr. Sarah Osmundson reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
The overall rate of positive glucose tolerance tests (GTT) or insulin use prior to the GTT – the primary study outcome – did not differ significantly between the groups but did trend toward lower in the early treatment group (45.2% vs. 55%; relative risk, 0.82), said Dr. Osmundson of Stanford (Calif.) University.
Further, although no difference was seen in the rate of gestational diabetes mellitus (GDM) among women with prepregnancy obesity in the early treatment and routine care groups, early treatment was associated with a 50% lower rate of GDM in nonobese women (29.6% vs. 59.1%, relative risk, 0.50), she said.
The participants had a singleton pregnancy, no chronic steroid use, and no preexisting diabetes. They were enrolled between May 2012 and June 2014, and all met with a certified diabetes educator at study entry to discuss healthy weight gain strategies in pregnancy and to set personalized weight gain goals.
Those in the early treatment group also were counseled to keep a diary to track food intake, were advised to monitor portion size, and limit carbohydrate intake to no more than 45% of total diet, and were seen by a dietitian or obstetrician every 2 weeks. They self-monitored blood glucose levels four times daily, and insulin was initiated if more than 20% of values were elevated.
The routine care group received usual prenatal care, including a visit with a provider every 4 weeks.
Patients in both groups underwent an oral GTT between 26 and 28 weeks of gestation.
Patients in the early treatment group with a positive GTT continued treatment, and those with a negative GTT continued treatment, but reduced monitoring to twice daily – returning to four times daily testing if levels increased. Those in the routine care group initiated treatment if the GTT was positive, and continued usual care if it was negative.
The groups gained a similar amount of weight during the study and did not differ in terms of insulin use, but the early treatment group started insulin at an earlier gestational age, and nonsignificant trends were seen toward a decrease in the primary outcome and toward lower GTT values in that group. The early treatment group patients also had a lower cesarean delivery rate (29.4% vs. 47,2%; RR, 0.63), but the difference did not reach statistical significance, Dr. Osmundson said.
Similarly, nonsignificant trends were seen toward lower infant birth weight, less macrosomia, and lower umbilical cord C-peptide levels in the early treatment group.
Glycosylated HbA1C is widely used for monitoring glycemic control, but was only recently adopted as an additional method of screening for diabetes. The measure has several advantages over the oral GTT, as it can be performed in a nonfasting state, requires only one blood draw, and provides information about average glucose exposure over time, she said.
The American Diabetes Association accepted HbA1C as an additional method for diagnosing type 2 diabetes in 2009, and classified those with levels between 5.7% and 6.4% as having prediabetes. That same year, an International Association of Diabetes in Pregnancy study group recommended that HbA1C of 6.5% or greater in pregnancy be considered overt diabetes, but made no recommendations regarding the management of those with prediabetic HbA1C, Dr. Osmundson said.
Prediabetes predicts a 50% cumulative incidence of type 2 diabetes within 5 years in nonpregnant patients, but much less is known about the condition in pregnant women, she added, noting that recent studies suggest a threefold increased risk for gestational diabetes in the second trimester – and perhaps even greater risk in obese women – among those with prediabetes.
The addition of HbA1C to the prenatal panel in California, along with a recommendation that those with prediabetes be diagnosed with and treated for gestational diabetes, provided the opportunity to evaluate whether such treatment affected the incidence of gestational diabetes as compared with usual care, she noted.
“We hypothesized that treatment would lower the risk of GDM, especially among obese women,” she said.
Though limited by the sample size and the fact that providers were not blinded to patients’ treatment group, the randomized, controlled study design is a strength, and the findings add to the limited data on HbA1C in pregnancy and the management of prediabetes in pregnant patients, she said.
The study was underpowered to determine whether early treatment reduces the risk of GDM in women with prediabetes, but the findings suggest that such treatment may reduce the risk among nonobese women.
“While this finding is unexpected, we think the findings are consistent with literature suggesting that women with prepregnancy obesity remain at higher risk of adverse perinatal outcomes even in absence of GDM or excessive weight gain. We hypothesize that any small effect may be attenuated by the morbidity associated with prepregnancy adiposity. Larger studies powered to examine the primary outcomes and perinatal outcomes are required,” she concluded.
This study was funded by the American College of Obstetricians and Gynecologists Abbott Nutrition Research Fellowship, the Stanford Child Health Institute, and the Valley Foundation for the California Institute of Medical Research. Dr. Osmundson reported having no disclosures.
SAN DIEGO– Early treatment of pregnant women with prediabetes led to lower hemoglobin A1C (HbA1C) levels during the second trimester and at delivery in a randomized, controlled trial.
Study subjects were 83 women with a first trimester HbA1C of 5.7%-6.4% (median of 5.8%) indicative of prediabetes. HbA1C levels during the second trimester were 5.2% and 5.3% in the 42 women who were randomized to receive early treatment and in the 41 who received routine care, respectively, and the levels at delivery were 5.5% and 5.8%, respectively, Dr. Sarah Osmundson reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
The overall rate of positive glucose tolerance tests (GTT) or insulin use prior to the GTT – the primary study outcome – did not differ significantly between the groups but did trend toward lower in the early treatment group (45.2% vs. 55%; relative risk, 0.82), said Dr. Osmundson of Stanford (Calif.) University.
Further, although no difference was seen in the rate of gestational diabetes mellitus (GDM) among women with prepregnancy obesity in the early treatment and routine care groups, early treatment was associated with a 50% lower rate of GDM in nonobese women (29.6% vs. 59.1%, relative risk, 0.50), she said.
The participants had a singleton pregnancy, no chronic steroid use, and no preexisting diabetes. They were enrolled between May 2012 and June 2014, and all met with a certified diabetes educator at study entry to discuss healthy weight gain strategies in pregnancy and to set personalized weight gain goals.
Those in the early treatment group also were counseled to keep a diary to track food intake, were advised to monitor portion size, and limit carbohydrate intake to no more than 45% of total diet, and were seen by a dietitian or obstetrician every 2 weeks. They self-monitored blood glucose levels four times daily, and insulin was initiated if more than 20% of values were elevated.
The routine care group received usual prenatal care, including a visit with a provider every 4 weeks.
Patients in both groups underwent an oral GTT between 26 and 28 weeks of gestation.
Patients in the early treatment group with a positive GTT continued treatment, and those with a negative GTT continued treatment, but reduced monitoring to twice daily – returning to four times daily testing if levels increased. Those in the routine care group initiated treatment if the GTT was positive, and continued usual care if it was negative.
The groups gained a similar amount of weight during the study and did not differ in terms of insulin use, but the early treatment group started insulin at an earlier gestational age, and nonsignificant trends were seen toward a decrease in the primary outcome and toward lower GTT values in that group. The early treatment group patients also had a lower cesarean delivery rate (29.4% vs. 47,2%; RR, 0.63), but the difference did not reach statistical significance, Dr. Osmundson said.
Similarly, nonsignificant trends were seen toward lower infant birth weight, less macrosomia, and lower umbilical cord C-peptide levels in the early treatment group.
Glycosylated HbA1C is widely used for monitoring glycemic control, but was only recently adopted as an additional method of screening for diabetes. The measure has several advantages over the oral GTT, as it can be performed in a nonfasting state, requires only one blood draw, and provides information about average glucose exposure over time, she said.
The American Diabetes Association accepted HbA1C as an additional method for diagnosing type 2 diabetes in 2009, and classified those with levels between 5.7% and 6.4% as having prediabetes. That same year, an International Association of Diabetes in Pregnancy study group recommended that HbA1C of 6.5% or greater in pregnancy be considered overt diabetes, but made no recommendations regarding the management of those with prediabetic HbA1C, Dr. Osmundson said.
Prediabetes predicts a 50% cumulative incidence of type 2 diabetes within 5 years in nonpregnant patients, but much less is known about the condition in pregnant women, she added, noting that recent studies suggest a threefold increased risk for gestational diabetes in the second trimester – and perhaps even greater risk in obese women – among those with prediabetes.
The addition of HbA1C to the prenatal panel in California, along with a recommendation that those with prediabetes be diagnosed with and treated for gestational diabetes, provided the opportunity to evaluate whether such treatment affected the incidence of gestational diabetes as compared with usual care, she noted.
“We hypothesized that treatment would lower the risk of GDM, especially among obese women,” she said.
Though limited by the sample size and the fact that providers were not blinded to patients’ treatment group, the randomized, controlled study design is a strength, and the findings add to the limited data on HbA1C in pregnancy and the management of prediabetes in pregnant patients, she said.
The study was underpowered to determine whether early treatment reduces the risk of GDM in women with prediabetes, but the findings suggest that such treatment may reduce the risk among nonobese women.
“While this finding is unexpected, we think the findings are consistent with literature suggesting that women with prepregnancy obesity remain at higher risk of adverse perinatal outcomes even in absence of GDM or excessive weight gain. We hypothesize that any small effect may be attenuated by the morbidity associated with prepregnancy adiposity. Larger studies powered to examine the primary outcomes and perinatal outcomes are required,” she concluded.
This study was funded by the American College of Obstetricians and Gynecologists Abbott Nutrition Research Fellowship, the Stanford Child Health Institute, and the Valley Foundation for the California Institute of Medical Research. Dr. Osmundson reported having no disclosures.
SAN DIEGO– Early treatment of pregnant women with prediabetes led to lower hemoglobin A1C (HbA1C) levels during the second trimester and at delivery in a randomized, controlled trial.
Study subjects were 83 women with a first trimester HbA1C of 5.7%-6.4% (median of 5.8%) indicative of prediabetes. HbA1C levels during the second trimester were 5.2% and 5.3% in the 42 women who were randomized to receive early treatment and in the 41 who received routine care, respectively, and the levels at delivery were 5.5% and 5.8%, respectively, Dr. Sarah Osmundson reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
The overall rate of positive glucose tolerance tests (GTT) or insulin use prior to the GTT – the primary study outcome – did not differ significantly between the groups but did trend toward lower in the early treatment group (45.2% vs. 55%; relative risk, 0.82), said Dr. Osmundson of Stanford (Calif.) University.
Further, although no difference was seen in the rate of gestational diabetes mellitus (GDM) among women with prepregnancy obesity in the early treatment and routine care groups, early treatment was associated with a 50% lower rate of GDM in nonobese women (29.6% vs. 59.1%, relative risk, 0.50), she said.
The participants had a singleton pregnancy, no chronic steroid use, and no preexisting diabetes. They were enrolled between May 2012 and June 2014, and all met with a certified diabetes educator at study entry to discuss healthy weight gain strategies in pregnancy and to set personalized weight gain goals.
Those in the early treatment group also were counseled to keep a diary to track food intake, were advised to monitor portion size, and limit carbohydrate intake to no more than 45% of total diet, and were seen by a dietitian or obstetrician every 2 weeks. They self-monitored blood glucose levels four times daily, and insulin was initiated if more than 20% of values were elevated.
The routine care group received usual prenatal care, including a visit with a provider every 4 weeks.
Patients in both groups underwent an oral GTT between 26 and 28 weeks of gestation.
Patients in the early treatment group with a positive GTT continued treatment, and those with a negative GTT continued treatment, but reduced monitoring to twice daily – returning to four times daily testing if levels increased. Those in the routine care group initiated treatment if the GTT was positive, and continued usual care if it was negative.
The groups gained a similar amount of weight during the study and did not differ in terms of insulin use, but the early treatment group started insulin at an earlier gestational age, and nonsignificant trends were seen toward a decrease in the primary outcome and toward lower GTT values in that group. The early treatment group patients also had a lower cesarean delivery rate (29.4% vs. 47,2%; RR, 0.63), but the difference did not reach statistical significance, Dr. Osmundson said.
Similarly, nonsignificant trends were seen toward lower infant birth weight, less macrosomia, and lower umbilical cord C-peptide levels in the early treatment group.
Glycosylated HbA1C is widely used for monitoring glycemic control, but was only recently adopted as an additional method of screening for diabetes. The measure has several advantages over the oral GTT, as it can be performed in a nonfasting state, requires only one blood draw, and provides information about average glucose exposure over time, she said.
The American Diabetes Association accepted HbA1C as an additional method for diagnosing type 2 diabetes in 2009, and classified those with levels between 5.7% and 6.4% as having prediabetes. That same year, an International Association of Diabetes in Pregnancy study group recommended that HbA1C of 6.5% or greater in pregnancy be considered overt diabetes, but made no recommendations regarding the management of those with prediabetic HbA1C, Dr. Osmundson said.
Prediabetes predicts a 50% cumulative incidence of type 2 diabetes within 5 years in nonpregnant patients, but much less is known about the condition in pregnant women, she added, noting that recent studies suggest a threefold increased risk for gestational diabetes in the second trimester – and perhaps even greater risk in obese women – among those with prediabetes.
The addition of HbA1C to the prenatal panel in California, along with a recommendation that those with prediabetes be diagnosed with and treated for gestational diabetes, provided the opportunity to evaluate whether such treatment affected the incidence of gestational diabetes as compared with usual care, she noted.
“We hypothesized that treatment would lower the risk of GDM, especially among obese women,” she said.
Though limited by the sample size and the fact that providers were not blinded to patients’ treatment group, the randomized, controlled study design is a strength, and the findings add to the limited data on HbA1C in pregnancy and the management of prediabetes in pregnant patients, she said.
The study was underpowered to determine whether early treatment reduces the risk of GDM in women with prediabetes, but the findings suggest that such treatment may reduce the risk among nonobese women.
“While this finding is unexpected, we think the findings are consistent with literature suggesting that women with prepregnancy obesity remain at higher risk of adverse perinatal outcomes even in absence of GDM or excessive weight gain. We hypothesize that any small effect may be attenuated by the morbidity associated with prepregnancy adiposity. Larger studies powered to examine the primary outcomes and perinatal outcomes are required,” she concluded.
This study was funded by the American College of Obstetricians and Gynecologists Abbott Nutrition Research Fellowship, the Stanford Child Health Institute, and the Valley Foundation for the California Institute of Medical Research. Dr. Osmundson reported having no disclosures.
Key clinical point: Addressing prediabetes early may improve outcomes, but risks of prepregnancy obesity persist.
Major finding: Second trimester and delivery HbA1C levels were significantly lower in patients with prediabetes who received early treatment vs. those who received routine care (5.2% vs. 5.3%; 5.5% vs. 5.8%, respectively).
Data source: A randomized controlled trial of 83 women.
Disclosures: This study was funded by the American College of Obstetricians and Gynecologists Abbott Nutrition Research Fellowship, the Stanford Child Health Institute, and the Valley Foundation for the California Institute of Medical Research. Dr. Osmundson reported having no disclosures.
Breast cancer patients show poor adherence to cardiovascular, diabetes medications
SAN ANTONIO – Hypertension, dyslipidemia, and type 2 diabetes are common among breast cancer survivors – and so is nonadherence to medications prescribed for these major comorbid conditions.
That was the central finding from COMBO (Commonly Used Medications and Breast Cancer Outcomes), a retrospective cohort study of 4,216 breast cancer survivors belonging to Group Health Cooperative, Gregory S. Calip, Pharm.D., reported at the San Antonio Breast Cancer Symposium.
“This is the first study to investigate breast cancer characteristics and treatments in relation to nonadherence to chronic medications for hypertension, diabetes, and dyslipidemia,” said Dr. Calip of the University of Illinois, Chicago. “Our results suggest that some breast cancer treatments may be associated with nonadherence to antihypertensive agents and oral diabetes medications, but not statins. These findings highlight possible opportunities to improve comorbid condition care in the growing population of breast cancer survivors.”
The irony is that while experiencing breast cancer understandably renders survivors deeply concerned about the prospect of cancer-related death, by not taking their medications for these common comorbid conditions these women increase their overall mortality risk, and particularly their risk of death due to cardiovascular disease and stroke.
The women in the COMBO study had been diagnosed with stage I or II breast cancer during 1990-2008 and did not experience recurrence or a second primary breast cancer during their second year after breast cancer diagnosis. Their medication adherence during that second year was measured via automated health plan pharmacy dispensing records. Patients were classified as nonadherent if their medication possession ratio, or MPR, was less than 0.8.
Antihypertensive agents were prescribed for 1,929 of the subjects, statins for 1,072, and oral diabetes drugs for 449.
During days 366-730 post breast cancer diagnosis, 37% of the women were nonadherent to antihypertensive medications, 39% to prescribed statins, and 75% to their oral diabetes medications.
Common forms of breast cancer therapy were independently associated with increased likelihood of nonadherence in multivariate logistic regression analysis. For example, chemotherapy was associated with a 67% increased likelihood of nonadherence to diabetes medications during year 2 after breast cancer diagnosis. Patients who received radiation therapy or hormonal therapy were, respectively, 21% and 25% more likely to be nonadherent to antihypertensive therapy.
One factor associated with increased likelihood of adherence to medications for comorbid conditions was greater contact with a primary care physician. Breast cancer survivors who saw their primary care physicians two or more times during year 2 post diagnosis were 70% less likely to be nonadherent to antihypertensive therapy than were those who visited their primary care physicians less frequently.
Greater body mass index was associated with significantly less likelihood of nonadherence to antihypertensive agents but not statins or diabetes medications. When researchers used a BMI below 25 kg/m2 for reference, patients with a BMI of 25-29.9 were 39% less likely to be nonadherent to antihypertensive therapy, those with a BMI of 30-34.9 kg/m2 were 46% less likely, and women with a BMI of 35 kg/m2 or greater were 63% less likely to be nonadherent to their antihypertensive therapy.
A higher Charlson comorbidity score of 2 or more during the first year following breast cancer diagnosis was associated with a 51% reduction in likelihood of nonadherence to diabetes medications during year 2 and a 46% lower nonadherence rate for statins than in patients with a Charlson score below 2.
As reported in previous studies of non-cancer patients, younger age was associated with increased nonadherence. This was true across the board for all three medication classes, although the age effect was most dramatic with respect to nonadherence to statins and oral diabetes medications. Fifty- to 54-year-olds were 3.4- and 1.8-fold more likely than were women age 65 or older to be nonadherent to diabetes drugs and statins, respectively, while breast cancer survivors under age 50 were 7.1- and 2.8-fold more likely to be nonadherent to those types of medications.
Discussant Dawn L. Hershman called the COMBO study medication nonadherence rates “pretty awful.” And if breast cancer survivors aren’t taking their medications for chronic comorbid conditions, it’s not much of a leap to think they may not be adherent to their breast cancer–related medications, she said. She urged her fellow breast cancer specialists to think beyond their specialty focus, consider the patient as a whole, and do what they can to promote adherence to medications targeting these potentially serious comorbidities.
“So, what can we do? We can try to engage technology,” said Dr. Hershman, a medical oncologist at Columbia University, New York.
She cited a randomized, controlled trial by other investigators which showed that automated phone calls reminding patients to take their cardiovascular medications had a salutary effect. In addition, she was an investigator in a large study of text messaging as an effective tool for improving adherence to hormonal therapy.
The COMBO study was supported by the National Cancer Institute and the University of Washington, Seattle. Dr. Calip reported having no financial conflicts.
SAN ANTONIO – Hypertension, dyslipidemia, and type 2 diabetes are common among breast cancer survivors – and so is nonadherence to medications prescribed for these major comorbid conditions.
That was the central finding from COMBO (Commonly Used Medications and Breast Cancer Outcomes), a retrospective cohort study of 4,216 breast cancer survivors belonging to Group Health Cooperative, Gregory S. Calip, Pharm.D., reported at the San Antonio Breast Cancer Symposium.
“This is the first study to investigate breast cancer characteristics and treatments in relation to nonadherence to chronic medications for hypertension, diabetes, and dyslipidemia,” said Dr. Calip of the University of Illinois, Chicago. “Our results suggest that some breast cancer treatments may be associated with nonadherence to antihypertensive agents and oral diabetes medications, but not statins. These findings highlight possible opportunities to improve comorbid condition care in the growing population of breast cancer survivors.”
The irony is that while experiencing breast cancer understandably renders survivors deeply concerned about the prospect of cancer-related death, by not taking their medications for these common comorbid conditions these women increase their overall mortality risk, and particularly their risk of death due to cardiovascular disease and stroke.
The women in the COMBO study had been diagnosed with stage I or II breast cancer during 1990-2008 and did not experience recurrence or a second primary breast cancer during their second year after breast cancer diagnosis. Their medication adherence during that second year was measured via automated health plan pharmacy dispensing records. Patients were classified as nonadherent if their medication possession ratio, or MPR, was less than 0.8.
Antihypertensive agents were prescribed for 1,929 of the subjects, statins for 1,072, and oral diabetes drugs for 449.
During days 366-730 post breast cancer diagnosis, 37% of the women were nonadherent to antihypertensive medications, 39% to prescribed statins, and 75% to their oral diabetes medications.
Common forms of breast cancer therapy were independently associated with increased likelihood of nonadherence in multivariate logistic regression analysis. For example, chemotherapy was associated with a 67% increased likelihood of nonadherence to diabetes medications during year 2 after breast cancer diagnosis. Patients who received radiation therapy or hormonal therapy were, respectively, 21% and 25% more likely to be nonadherent to antihypertensive therapy.
One factor associated with increased likelihood of adherence to medications for comorbid conditions was greater contact with a primary care physician. Breast cancer survivors who saw their primary care physicians two or more times during year 2 post diagnosis were 70% less likely to be nonadherent to antihypertensive therapy than were those who visited their primary care physicians less frequently.
Greater body mass index was associated with significantly less likelihood of nonadherence to antihypertensive agents but not statins or diabetes medications. When researchers used a BMI below 25 kg/m2 for reference, patients with a BMI of 25-29.9 were 39% less likely to be nonadherent to antihypertensive therapy, those with a BMI of 30-34.9 kg/m2 were 46% less likely, and women with a BMI of 35 kg/m2 or greater were 63% less likely to be nonadherent to their antihypertensive therapy.
A higher Charlson comorbidity score of 2 or more during the first year following breast cancer diagnosis was associated with a 51% reduction in likelihood of nonadherence to diabetes medications during year 2 and a 46% lower nonadherence rate for statins than in patients with a Charlson score below 2.
As reported in previous studies of non-cancer patients, younger age was associated with increased nonadherence. This was true across the board for all three medication classes, although the age effect was most dramatic with respect to nonadherence to statins and oral diabetes medications. Fifty- to 54-year-olds were 3.4- and 1.8-fold more likely than were women age 65 or older to be nonadherent to diabetes drugs and statins, respectively, while breast cancer survivors under age 50 were 7.1- and 2.8-fold more likely to be nonadherent to those types of medications.
Discussant Dawn L. Hershman called the COMBO study medication nonadherence rates “pretty awful.” And if breast cancer survivors aren’t taking their medications for chronic comorbid conditions, it’s not much of a leap to think they may not be adherent to their breast cancer–related medications, she said. She urged her fellow breast cancer specialists to think beyond their specialty focus, consider the patient as a whole, and do what they can to promote adherence to medications targeting these potentially serious comorbidities.
“So, what can we do? We can try to engage technology,” said Dr. Hershman, a medical oncologist at Columbia University, New York.
She cited a randomized, controlled trial by other investigators which showed that automated phone calls reminding patients to take their cardiovascular medications had a salutary effect. In addition, she was an investigator in a large study of text messaging as an effective tool for improving adherence to hormonal therapy.
The COMBO study was supported by the National Cancer Institute and the University of Washington, Seattle. Dr. Calip reported having no financial conflicts.
SAN ANTONIO – Hypertension, dyslipidemia, and type 2 diabetes are common among breast cancer survivors – and so is nonadherence to medications prescribed for these major comorbid conditions.
That was the central finding from COMBO (Commonly Used Medications and Breast Cancer Outcomes), a retrospective cohort study of 4,216 breast cancer survivors belonging to Group Health Cooperative, Gregory S. Calip, Pharm.D., reported at the San Antonio Breast Cancer Symposium.
“This is the first study to investigate breast cancer characteristics and treatments in relation to nonadherence to chronic medications for hypertension, diabetes, and dyslipidemia,” said Dr. Calip of the University of Illinois, Chicago. “Our results suggest that some breast cancer treatments may be associated with nonadherence to antihypertensive agents and oral diabetes medications, but not statins. These findings highlight possible opportunities to improve comorbid condition care in the growing population of breast cancer survivors.”
The irony is that while experiencing breast cancer understandably renders survivors deeply concerned about the prospect of cancer-related death, by not taking their medications for these common comorbid conditions these women increase their overall mortality risk, and particularly their risk of death due to cardiovascular disease and stroke.
The women in the COMBO study had been diagnosed with stage I or II breast cancer during 1990-2008 and did not experience recurrence or a second primary breast cancer during their second year after breast cancer diagnosis. Their medication adherence during that second year was measured via automated health plan pharmacy dispensing records. Patients were classified as nonadherent if their medication possession ratio, or MPR, was less than 0.8.
Antihypertensive agents were prescribed for 1,929 of the subjects, statins for 1,072, and oral diabetes drugs for 449.
During days 366-730 post breast cancer diagnosis, 37% of the women were nonadherent to antihypertensive medications, 39% to prescribed statins, and 75% to their oral diabetes medications.
Common forms of breast cancer therapy were independently associated with increased likelihood of nonadherence in multivariate logistic regression analysis. For example, chemotherapy was associated with a 67% increased likelihood of nonadherence to diabetes medications during year 2 after breast cancer diagnosis. Patients who received radiation therapy or hormonal therapy were, respectively, 21% and 25% more likely to be nonadherent to antihypertensive therapy.
One factor associated with increased likelihood of adherence to medications for comorbid conditions was greater contact with a primary care physician. Breast cancer survivors who saw their primary care physicians two or more times during year 2 post diagnosis were 70% less likely to be nonadherent to antihypertensive therapy than were those who visited their primary care physicians less frequently.
Greater body mass index was associated with significantly less likelihood of nonadherence to antihypertensive agents but not statins or diabetes medications. When researchers used a BMI below 25 kg/m2 for reference, patients with a BMI of 25-29.9 were 39% less likely to be nonadherent to antihypertensive therapy, those with a BMI of 30-34.9 kg/m2 were 46% less likely, and women with a BMI of 35 kg/m2 or greater were 63% less likely to be nonadherent to their antihypertensive therapy.
A higher Charlson comorbidity score of 2 or more during the first year following breast cancer diagnosis was associated with a 51% reduction in likelihood of nonadherence to diabetes medications during year 2 and a 46% lower nonadherence rate for statins than in patients with a Charlson score below 2.
As reported in previous studies of non-cancer patients, younger age was associated with increased nonadherence. This was true across the board for all three medication classes, although the age effect was most dramatic with respect to nonadherence to statins and oral diabetes medications. Fifty- to 54-year-olds were 3.4- and 1.8-fold more likely than were women age 65 or older to be nonadherent to diabetes drugs and statins, respectively, while breast cancer survivors under age 50 were 7.1- and 2.8-fold more likely to be nonadherent to those types of medications.
Discussant Dawn L. Hershman called the COMBO study medication nonadherence rates “pretty awful.” And if breast cancer survivors aren’t taking their medications for chronic comorbid conditions, it’s not much of a leap to think they may not be adherent to their breast cancer–related medications, she said. She urged her fellow breast cancer specialists to think beyond their specialty focus, consider the patient as a whole, and do what they can to promote adherence to medications targeting these potentially serious comorbidities.
“So, what can we do? We can try to engage technology,” said Dr. Hershman, a medical oncologist at Columbia University, New York.
She cited a randomized, controlled trial by other investigators which showed that automated phone calls reminding patients to take their cardiovascular medications had a salutary effect. In addition, she was an investigator in a large study of text messaging as an effective tool for improving adherence to hormonal therapy.
The COMBO study was supported by the National Cancer Institute and the University of Washington, Seattle. Dr. Calip reported having no financial conflicts.
AT SABCS 2014
Key clinical point: Breast cancer survivors’ adherence rates to medications prescribed for comorbid hypertension, dyslipidemia, and type 2 diabetes were characterized as “pretty awful.”
Major finding: During the second year after breast cancer diagnosis, the rates of nonadherence to antihypertensive agents, statins, and oral diabetes medications were 37%, 75%, and 39%, respectively.
Data source: COMBO, a retrospective cohort study involving 4,216 breast cancer survivors without a disease recurrence or second primary breast cancer during the first 2 years post diagnosis.
Disclosures: The National Cancer Institute and the University of Washington supported the study. Dr. Calip reported having no financial conflicts.
FDA approves empagliflozin-linagliptin combo tablet
A combined tablet formulation of empagliflozin and linagliptin has been approved for adults with type 2 diabetes by the Food and Drug Administration, according to Boehringer Ingelheim Pharmaceuticals.
The approved indication is to improve glycemic control, as an adjunct to diet and exercise, in adults with type 2 diabetes, when both agents are appropriate treatments, the company said in a statement issued Feb 2.
Empagliflozin (marketed as Jardiance) is a sodium glucose cotransporter–2 (SGLT2) inhibitor, which reduces renal absorption of glucose and increases the excretion of urinary glucose. It was approved in August 2014. Linagliptin (marketed as Tradjenta) is a dipeptidyl peptidase–4 (DPP-4) inhibitor, which increases the concentrations of incretin hormones, “stimulating the release of insulin in a glucose-dependent manner and decreasing the levels of glucagon in the circulation,” according to the prescribing information. It was approved in 2011. In 2012, linagliptin was approved in a combination tablet with metformin (Jentadueto).
Approval was based on a phase III study of 677 patients with type 2 diabetes not adequately controlled on at least 1,500 mg of metformin a day. At 24 weeks, those randomized to treatment with empagliflozin 10 mg or 25 mg in combination with 5 mg of linagliptin, as the fixed-dose combination tablet, had statistically significant improvements in hemoglobin A1c and fasting blood glucose levels at 24 weeks, compared with those on the individual components. Reductions with empagliflozin 10 mg/linagliptin 5 mg were significantly greater than with the individual components, and reductions with empagliflozin 25 mg/linagliptin 5 mg were significantly greater, compared with linagliptin 5 mg but not compared with empagliflozin 25 mg, according to the trial results, published online Jan. 29 (Diabetes Care 2015 [doi:10.2337/dc14-2365]) . The approved product contains 10 mg empagliflozin/5 mg linagliptin, to be taken once daily in the morning.
The most common adverse reactions associated with the combination were urinary tract infections (in 11.4%-12.5% of treated patients), as well as nasopharyngitis and upper respiratory tract infections, according to the prescribing information.
The combination tablets will be marketed as Glyxambi by Boehringer Ingelheim and Eli Lilly. This is the first product that combines these two drug classes into one tablet, according to the release.
Serious adverse events associated with this product and other drugs should be reported to the FDA at 800-332-1088 or www.fda.gov/Safety/MedWatch.
A combined tablet formulation of empagliflozin and linagliptin has been approved for adults with type 2 diabetes by the Food and Drug Administration, according to Boehringer Ingelheim Pharmaceuticals.
The approved indication is to improve glycemic control, as an adjunct to diet and exercise, in adults with type 2 diabetes, when both agents are appropriate treatments, the company said in a statement issued Feb 2.
Empagliflozin (marketed as Jardiance) is a sodium glucose cotransporter–2 (SGLT2) inhibitor, which reduces renal absorption of glucose and increases the excretion of urinary glucose. It was approved in August 2014. Linagliptin (marketed as Tradjenta) is a dipeptidyl peptidase–4 (DPP-4) inhibitor, which increases the concentrations of incretin hormones, “stimulating the release of insulin in a glucose-dependent manner and decreasing the levels of glucagon in the circulation,” according to the prescribing information. It was approved in 2011. In 2012, linagliptin was approved in a combination tablet with metformin (Jentadueto).
Approval was based on a phase III study of 677 patients with type 2 diabetes not adequately controlled on at least 1,500 mg of metformin a day. At 24 weeks, those randomized to treatment with empagliflozin 10 mg or 25 mg in combination with 5 mg of linagliptin, as the fixed-dose combination tablet, had statistically significant improvements in hemoglobin A1c and fasting blood glucose levels at 24 weeks, compared with those on the individual components. Reductions with empagliflozin 10 mg/linagliptin 5 mg were significantly greater than with the individual components, and reductions with empagliflozin 25 mg/linagliptin 5 mg were significantly greater, compared with linagliptin 5 mg but not compared with empagliflozin 25 mg, according to the trial results, published online Jan. 29 (Diabetes Care 2015 [doi:10.2337/dc14-2365]) . The approved product contains 10 mg empagliflozin/5 mg linagliptin, to be taken once daily in the morning.
The most common adverse reactions associated with the combination were urinary tract infections (in 11.4%-12.5% of treated patients), as well as nasopharyngitis and upper respiratory tract infections, according to the prescribing information.
The combination tablets will be marketed as Glyxambi by Boehringer Ingelheim and Eli Lilly. This is the first product that combines these two drug classes into one tablet, according to the release.
Serious adverse events associated with this product and other drugs should be reported to the FDA at 800-332-1088 or www.fda.gov/Safety/MedWatch.
A combined tablet formulation of empagliflozin and linagliptin has been approved for adults with type 2 diabetes by the Food and Drug Administration, according to Boehringer Ingelheim Pharmaceuticals.
The approved indication is to improve glycemic control, as an adjunct to diet and exercise, in adults with type 2 diabetes, when both agents are appropriate treatments, the company said in a statement issued Feb 2.
Empagliflozin (marketed as Jardiance) is a sodium glucose cotransporter–2 (SGLT2) inhibitor, which reduces renal absorption of glucose and increases the excretion of urinary glucose. It was approved in August 2014. Linagliptin (marketed as Tradjenta) is a dipeptidyl peptidase–4 (DPP-4) inhibitor, which increases the concentrations of incretin hormones, “stimulating the release of insulin in a glucose-dependent manner and decreasing the levels of glucagon in the circulation,” according to the prescribing information. It was approved in 2011. In 2012, linagliptin was approved in a combination tablet with metformin (Jentadueto).
Approval was based on a phase III study of 677 patients with type 2 diabetes not adequately controlled on at least 1,500 mg of metformin a day. At 24 weeks, those randomized to treatment with empagliflozin 10 mg or 25 mg in combination with 5 mg of linagliptin, as the fixed-dose combination tablet, had statistically significant improvements in hemoglobin A1c and fasting blood glucose levels at 24 weeks, compared with those on the individual components. Reductions with empagliflozin 10 mg/linagliptin 5 mg were significantly greater than with the individual components, and reductions with empagliflozin 25 mg/linagliptin 5 mg were significantly greater, compared with linagliptin 5 mg but not compared with empagliflozin 25 mg, according to the trial results, published online Jan. 29 (Diabetes Care 2015 [doi:10.2337/dc14-2365]) . The approved product contains 10 mg empagliflozin/5 mg linagliptin, to be taken once daily in the morning.
The most common adverse reactions associated with the combination were urinary tract infections (in 11.4%-12.5% of treated patients), as well as nasopharyngitis and upper respiratory tract infections, according to the prescribing information.
The combination tablets will be marketed as Glyxambi by Boehringer Ingelheim and Eli Lilly. This is the first product that combines these two drug classes into one tablet, according to the release.
Serious adverse events associated with this product and other drugs should be reported to the FDA at 800-332-1088 or www.fda.gov/Safety/MedWatch.
Overtreatment of diabetes
One out of every 10 adults in the United States has diabetes, and the percentage of Americans aged 65 years or older who have diabetes continues to increase. The treatment of diabetes consumes an enormous amount of health care and personal resources. This would palatable if such expenditures did nothing but improve outcomes and reduce morbidity and mortality.
But they don’t.
Compared with young healthy patients with diabetes, older patients with diabetes and complex medical conditions may derive little benefit from intensive management but may incur harm. Hypoglycemia is associated with significant medical costs and adverse health consequences among older patients. Hypoglycemic agents (oral and injectable) are implicated in one-fourth of emergency hospitalizations for adverse drugs events in this population.
Dr. Kasia J. Lipska of Yale University, New Haven, Conn., and her colleagues evaluated the potential overtreatment of diabetes in older patients (at least 65 years) by examining participants in the National Health and Nutrition Examination Survey from 2001 through 2010 who had an HbA1c measurement. Participants were grouped into different health status categories using available data: very complex/poor, complex/intermediate, and relatively healthy (JAMA Intern. Med. 2015 [doi:10.1001/jamainternmed.2014.7345]).
The investigators found that almost two-thirds of this population had an HbA1c less than 7% (i.e., tight control), which did not differ across health status categories. Of the adults with an HbA1c less than 7%, more than one-half were treated with insulin or sulfonylureas, and this was similar across health status categories. During the 10 study years, no changes were observed in the proportion with an HbA1c less than 7% or the proportion of patients with an HbA1c less than 7% who were treated with insulin or a sulfonylurea.
These data tell us we are not racheting our care back when patients reach an age when aggressive care does more harm than good. We may feel hamstrung by quality metrics, a limited ability to manage large populations using health management approach, algorithmic approaches to facilitate appropriate de-escalations in medication management, and lack of time to engage in these discussions with our patients. What we tend to do is decrease these medications after patients have an office or emergency department visit for a hypoglycemic event or complication.
Moving forward, we need to embrace more liberal HbA1c goals for our patients at least 65 years of age. Most important, yet most challenging, we need to have ongoing goals of care discussions with our patients, and comorbidities need to be considered when setting such goals. Decision aids would be helpful tools in this space.
Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author and do not necessarily represent the views and opinions of the Mayo Clinic. The opinions expressed in this article should not be used to diagnose or treat any medical condition, nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician.
One out of every 10 adults in the United States has diabetes, and the percentage of Americans aged 65 years or older who have diabetes continues to increase. The treatment of diabetes consumes an enormous amount of health care and personal resources. This would palatable if such expenditures did nothing but improve outcomes and reduce morbidity and mortality.
But they don’t.
Compared with young healthy patients with diabetes, older patients with diabetes and complex medical conditions may derive little benefit from intensive management but may incur harm. Hypoglycemia is associated with significant medical costs and adverse health consequences among older patients. Hypoglycemic agents (oral and injectable) are implicated in one-fourth of emergency hospitalizations for adverse drugs events in this population.
Dr. Kasia J. Lipska of Yale University, New Haven, Conn., and her colleagues evaluated the potential overtreatment of diabetes in older patients (at least 65 years) by examining participants in the National Health and Nutrition Examination Survey from 2001 through 2010 who had an HbA1c measurement. Participants were grouped into different health status categories using available data: very complex/poor, complex/intermediate, and relatively healthy (JAMA Intern. Med. 2015 [doi:10.1001/jamainternmed.2014.7345]).
The investigators found that almost two-thirds of this population had an HbA1c less than 7% (i.e., tight control), which did not differ across health status categories. Of the adults with an HbA1c less than 7%, more than one-half were treated with insulin or sulfonylureas, and this was similar across health status categories. During the 10 study years, no changes were observed in the proportion with an HbA1c less than 7% or the proportion of patients with an HbA1c less than 7% who were treated with insulin or a sulfonylurea.
These data tell us we are not racheting our care back when patients reach an age when aggressive care does more harm than good. We may feel hamstrung by quality metrics, a limited ability to manage large populations using health management approach, algorithmic approaches to facilitate appropriate de-escalations in medication management, and lack of time to engage in these discussions with our patients. What we tend to do is decrease these medications after patients have an office or emergency department visit for a hypoglycemic event or complication.
Moving forward, we need to embrace more liberal HbA1c goals for our patients at least 65 years of age. Most important, yet most challenging, we need to have ongoing goals of care discussions with our patients, and comorbidities need to be considered when setting such goals. Decision aids would be helpful tools in this space.
Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author and do not necessarily represent the views and opinions of the Mayo Clinic. The opinions expressed in this article should not be used to diagnose or treat any medical condition, nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician.
One out of every 10 adults in the United States has diabetes, and the percentage of Americans aged 65 years or older who have diabetes continues to increase. The treatment of diabetes consumes an enormous amount of health care and personal resources. This would palatable if such expenditures did nothing but improve outcomes and reduce morbidity and mortality.
But they don’t.
Compared with young healthy patients with diabetes, older patients with diabetes and complex medical conditions may derive little benefit from intensive management but may incur harm. Hypoglycemia is associated with significant medical costs and adverse health consequences among older patients. Hypoglycemic agents (oral and injectable) are implicated in one-fourth of emergency hospitalizations for adverse drugs events in this population.
Dr. Kasia J. Lipska of Yale University, New Haven, Conn., and her colleagues evaluated the potential overtreatment of diabetes in older patients (at least 65 years) by examining participants in the National Health and Nutrition Examination Survey from 2001 through 2010 who had an HbA1c measurement. Participants were grouped into different health status categories using available data: very complex/poor, complex/intermediate, and relatively healthy (JAMA Intern. Med. 2015 [doi:10.1001/jamainternmed.2014.7345]).
The investigators found that almost two-thirds of this population had an HbA1c less than 7% (i.e., tight control), which did not differ across health status categories. Of the adults with an HbA1c less than 7%, more than one-half were treated with insulin or sulfonylureas, and this was similar across health status categories. During the 10 study years, no changes were observed in the proportion with an HbA1c less than 7% or the proportion of patients with an HbA1c less than 7% who were treated with insulin or a sulfonylurea.
These data tell us we are not racheting our care back when patients reach an age when aggressive care does more harm than good. We may feel hamstrung by quality metrics, a limited ability to manage large populations using health management approach, algorithmic approaches to facilitate appropriate de-escalations in medication management, and lack of time to engage in these discussions with our patients. What we tend to do is decrease these medications after patients have an office or emergency department visit for a hypoglycemic event or complication.
Moving forward, we need to embrace more liberal HbA1c goals for our patients at least 65 years of age. Most important, yet most challenging, we need to have ongoing goals of care discussions with our patients, and comorbidities need to be considered when setting such goals. Decision aids would be helpful tools in this space.
Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author and do not necessarily represent the views and opinions of the Mayo Clinic. The opinions expressed in this article should not be used to diagnose or treat any medical condition, nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician.
Metformin linked to lower risk of lung cancer in diabetic nonsmokers
In nonsmokers with diabetes, patients who used metformin had a decreased risk of lung cancer, according to Dr. Lori Sakoda and associates at the Kaiser Permanente Division of Research, Oakland, Calif.
In a retrospective cohort study of 47,351 diabetic patients, 46% were metformin users. In total, 747 patients were diagnosed with lung cancer during follow-up of 15 years, including 80 nonsmokers and 203 current smokers. Metformin use was associated with a 43% lower lung cancer risk in diabetic nonsmokers, with risk continuing to decrease with longer use of the drug. Metformin use was not associated with lower lung cancer risk overall.
These results suggest that the risks associated with metformin may vary according to a patient’s smoking history, Dr. Sakoda said. Read the full article at: http://cancerpreventionresearch.aacrjournals.org/.
In nonsmokers with diabetes, patients who used metformin had a decreased risk of lung cancer, according to Dr. Lori Sakoda and associates at the Kaiser Permanente Division of Research, Oakland, Calif.
In a retrospective cohort study of 47,351 diabetic patients, 46% were metformin users. In total, 747 patients were diagnosed with lung cancer during follow-up of 15 years, including 80 nonsmokers and 203 current smokers. Metformin use was associated with a 43% lower lung cancer risk in diabetic nonsmokers, with risk continuing to decrease with longer use of the drug. Metformin use was not associated with lower lung cancer risk overall.
These results suggest that the risks associated with metformin may vary according to a patient’s smoking history, Dr. Sakoda said. Read the full article at: http://cancerpreventionresearch.aacrjournals.org/.
In nonsmokers with diabetes, patients who used metformin had a decreased risk of lung cancer, according to Dr. Lori Sakoda and associates at the Kaiser Permanente Division of Research, Oakland, Calif.
In a retrospective cohort study of 47,351 diabetic patients, 46% were metformin users. In total, 747 patients were diagnosed with lung cancer during follow-up of 15 years, including 80 nonsmokers and 203 current smokers. Metformin use was associated with a 43% lower lung cancer risk in diabetic nonsmokers, with risk continuing to decrease with longer use of the drug. Metformin use was not associated with lower lung cancer risk overall.
These results suggest that the risks associated with metformin may vary according to a patient’s smoking history, Dr. Sakoda said. Read the full article at: http://cancerpreventionresearch.aacrjournals.org/.
Broad application of JNC-8 would save lives, reduce costs
Antihypertensive therapy would prevent about 56,000 cardiovascular events annually and 13,000 deaths from strokes, myocardial infarctions, and other causes if it were used by all U.S. adults who qualify for treatment under 2014 Joint National Committee hypertension guidelines, according to computer modeling published online Jan. 28 in the New England Journal of Medicine.
Even though the new Joint Committee guidelines are a bit less stringent than the committee’s prior 2003 advice, blood pressure remains inadequately controlled in 44% of the 64 million U.S. adults with hypertension, according to the investigators, led by Dr. Andrew Moran of Columbia University Medical Center, New York (N. Engl. J. Med. 2015;372:447-55).
The team used data from the National Health and Nutrition Examination Survey, the Framingham Heart Study, and other sources to estimate costs and benefits of expanding treatment to all U.S. adults aged 35-74 years who meet the 2014 benchmarks. They then calculated cost-effectiveness of expanding use in various subpopulations, using $50,000/quality-adjusted life-year (QALY) gained, or less, as their cut-off.
Overall, the investigators found that fuller implementation of the Joint Committee goals would pay for itself in reduced cardiovascular morbidity and mortality. The results were driven primarily by secondary prevention in patients with cardiovascular disease and primary prevention in patients with stage 2 hypertension, meaning systolic BP of 160 mm Hg or higher or diastolic BP of 100 mm Hg or higher.
“There is an enormous potential for improving population health by expanding treatment and improving control. Our findings clearly show that it would be worthwhile to significantly increase spending on office visits, home blood pressure monitoring, and interventions to improve treatment adherence. In fact, we could double treatment and monitoring spending for some patients – namely those with severe hypertension – and still break even,” Dr. Moran said in a statement announcing the results.
Treatment of patients with existing cardiovascular disease or stage 2 hypertension would save lives and costs in all men 35-74 years old and in women aged 45-74 years. The treatment of more modest hypertension – systolic BP of 140-159 mm Hg or a diastolic BP of 90-99 mm Hg – was cost effective for all men and for women also between the ages of 45 and 74 years, but treating women 35-44 years old with moderate hypertension and diabetes or kidney disease had intermediate cost-effectiveness ($125,000 per QALY), and low cost-effectiveness ($181,000 per QALY) if those comorbidities were not present.
“Some people will be alarmed about our conclusion that it may not be cost effective to treat hypertension in young adults, especially young women. It’s worth noting that our analysis didn’t capture the cumulative, lifetime effects of hypertension. It may well turn out to be cost effective to treat this group if we look at data on costs and benefits over several decades,” Dr. Moran said.
The team assumed a medication adherence rate of 75%. The costs of treatment included medications, monitoring, and drug side effects.
They did not analyze the effect of diet and lifestyle interventions for lowering blood pressure, or compare the cost-effectiveness of specific antihypertensive medication classes or combinations.
The work was funded by the National Heart, Lung, and Blood Institute, among others. The authors reported no relevant financial disclosures.
Antihypertensive therapy would prevent about 56,000 cardiovascular events annually and 13,000 deaths from strokes, myocardial infarctions, and other causes if it were used by all U.S. adults who qualify for treatment under 2014 Joint National Committee hypertension guidelines, according to computer modeling published online Jan. 28 in the New England Journal of Medicine.
Even though the new Joint Committee guidelines are a bit less stringent than the committee’s prior 2003 advice, blood pressure remains inadequately controlled in 44% of the 64 million U.S. adults with hypertension, according to the investigators, led by Dr. Andrew Moran of Columbia University Medical Center, New York (N. Engl. J. Med. 2015;372:447-55).
The team used data from the National Health and Nutrition Examination Survey, the Framingham Heart Study, and other sources to estimate costs and benefits of expanding treatment to all U.S. adults aged 35-74 years who meet the 2014 benchmarks. They then calculated cost-effectiveness of expanding use in various subpopulations, using $50,000/quality-adjusted life-year (QALY) gained, or less, as their cut-off.
Overall, the investigators found that fuller implementation of the Joint Committee goals would pay for itself in reduced cardiovascular morbidity and mortality. The results were driven primarily by secondary prevention in patients with cardiovascular disease and primary prevention in patients with stage 2 hypertension, meaning systolic BP of 160 mm Hg or higher or diastolic BP of 100 mm Hg or higher.
“There is an enormous potential for improving population health by expanding treatment and improving control. Our findings clearly show that it would be worthwhile to significantly increase spending on office visits, home blood pressure monitoring, and interventions to improve treatment adherence. In fact, we could double treatment and monitoring spending for some patients – namely those with severe hypertension – and still break even,” Dr. Moran said in a statement announcing the results.
Treatment of patients with existing cardiovascular disease or stage 2 hypertension would save lives and costs in all men 35-74 years old and in women aged 45-74 years. The treatment of more modest hypertension – systolic BP of 140-159 mm Hg or a diastolic BP of 90-99 mm Hg – was cost effective for all men and for women also between the ages of 45 and 74 years, but treating women 35-44 years old with moderate hypertension and diabetes or kidney disease had intermediate cost-effectiveness ($125,000 per QALY), and low cost-effectiveness ($181,000 per QALY) if those comorbidities were not present.
“Some people will be alarmed about our conclusion that it may not be cost effective to treat hypertension in young adults, especially young women. It’s worth noting that our analysis didn’t capture the cumulative, lifetime effects of hypertension. It may well turn out to be cost effective to treat this group if we look at data on costs and benefits over several decades,” Dr. Moran said.
The team assumed a medication adherence rate of 75%. The costs of treatment included medications, monitoring, and drug side effects.
They did not analyze the effect of diet and lifestyle interventions for lowering blood pressure, or compare the cost-effectiveness of specific antihypertensive medication classes or combinations.
The work was funded by the National Heart, Lung, and Blood Institute, among others. The authors reported no relevant financial disclosures.
Antihypertensive therapy would prevent about 56,000 cardiovascular events annually and 13,000 deaths from strokes, myocardial infarctions, and other causes if it were used by all U.S. adults who qualify for treatment under 2014 Joint National Committee hypertension guidelines, according to computer modeling published online Jan. 28 in the New England Journal of Medicine.
Even though the new Joint Committee guidelines are a bit less stringent than the committee’s prior 2003 advice, blood pressure remains inadequately controlled in 44% of the 64 million U.S. adults with hypertension, according to the investigators, led by Dr. Andrew Moran of Columbia University Medical Center, New York (N. Engl. J. Med. 2015;372:447-55).
The team used data from the National Health and Nutrition Examination Survey, the Framingham Heart Study, and other sources to estimate costs and benefits of expanding treatment to all U.S. adults aged 35-74 years who meet the 2014 benchmarks. They then calculated cost-effectiveness of expanding use in various subpopulations, using $50,000/quality-adjusted life-year (QALY) gained, or less, as their cut-off.
Overall, the investigators found that fuller implementation of the Joint Committee goals would pay for itself in reduced cardiovascular morbidity and mortality. The results were driven primarily by secondary prevention in patients with cardiovascular disease and primary prevention in patients with stage 2 hypertension, meaning systolic BP of 160 mm Hg or higher or diastolic BP of 100 mm Hg or higher.
“There is an enormous potential for improving population health by expanding treatment and improving control. Our findings clearly show that it would be worthwhile to significantly increase spending on office visits, home blood pressure monitoring, and interventions to improve treatment adherence. In fact, we could double treatment and monitoring spending for some patients – namely those with severe hypertension – and still break even,” Dr. Moran said in a statement announcing the results.
Treatment of patients with existing cardiovascular disease or stage 2 hypertension would save lives and costs in all men 35-74 years old and in women aged 45-74 years. The treatment of more modest hypertension – systolic BP of 140-159 mm Hg or a diastolic BP of 90-99 mm Hg – was cost effective for all men and for women also between the ages of 45 and 74 years, but treating women 35-44 years old with moderate hypertension and diabetes or kidney disease had intermediate cost-effectiveness ($125,000 per QALY), and low cost-effectiveness ($181,000 per QALY) if those comorbidities were not present.
“Some people will be alarmed about our conclusion that it may not be cost effective to treat hypertension in young adults, especially young women. It’s worth noting that our analysis didn’t capture the cumulative, lifetime effects of hypertension. It may well turn out to be cost effective to treat this group if we look at data on costs and benefits over several decades,” Dr. Moran said.
The team assumed a medication adherence rate of 75%. The costs of treatment included medications, monitoring, and drug side effects.
They did not analyze the effect of diet and lifestyle interventions for lowering blood pressure, or compare the cost-effectiveness of specific antihypertensive medication classes or combinations.
The work was funded by the National Heart, Lung, and Blood Institute, among others. The authors reported no relevant financial disclosures.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: Even young patients, in many cases, can benefit from adherence to theJoint National Committee 2014 hypertension guidelines.
Major finding: The treatment of modest hypertension is cost effective for men 35-74 years old, and women between the ages of 45 and 74 years, meaning that each quality-adjusted life-year gained would cost less than $50,000.
Data source: Computer estimates of the impact of applying JNC-8 to all hypertensive U.S. adults 35-74 years old.
Disclosures: The work was funded by the National Heart, Lung, and Blood Institute, among others. The authors reported no relevant financial disclosures.
