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AACE: Updated lipid guidelines include ‘extreme risk’ category
according to a summary by the American Association of Clinical Endocrinologists and American College of Endocrinology.
Achieving such a low LDL-cholesterol (LDL-C) level is possible with well-established medications such as a combination of simvastatin and ezetimibe and the newer, more clinically powerful agent PCSK9 inhibitors, Paul S. Jellinger, MD, chair of the guideline committee and professor of clinical medicine, University of Miami, said in an interview. The “extreme risk” category was derived largely from IMPROVE-IT and supporting meta-analyses.
The new category applies to patients with established atherosclerotic cardiovascular disease (ASCVD) who have any of the following risk factors:
• Progressive ASCVD including unstable angina after achieving an LDL-C level less than 70 mg/dL.
• Type 2 diabetes mellitus, chronic kidney disease stage 3 or 4, or heterozygous familial hypercholesterolemia.
• A history of premature ASCVD (before age 55 years in men, 65 years in women).
Heterozygous hypercholesterolemia is more common than many physicians realize, affecting as it does 1 in 250 people, Dr. Jellinger noted.
“Supporting evidence for the ‘extreme risk’ category with an LDL-C of less than 55 mg/dL was recently announced with the top line results from the FOURIER CVD outcome trial utilizing PCSK9-inhibitor therapy, which met both its primary and secondary endpoints,” he stressed.
PCSK9 inhibitors are extremely expensive, said Dr. Jellinger. “In my view, payers should not be denying patients who clearly meet the Food and Drug Administration approved indications for PCSK9 inhibitors and those within the extreme risk criteria. Yet, I have been made aware that 80% of insurance claims for PCSK9 inhibitors in these extremely high-risk and vulnerable patients are being denied.”
Inclusion in the updated AACE lipid management guidelines should strengthen PCSK9 inhibitors’ place among lipid-lowering drugs that are acceptable to insurance companies by making it clear that PCSK9 is appropriate and indicated for select patients, according to Dr. Jellinger.
Aside from creation of the extreme risk category, the AACE lipid guidelines discuss the available tools for making a global risk assessment of having a cardiac, vascular, or stroke event in the next 10 years, without favoring any one risk score. Among the systems discussed, with links, are the Framingham, MESA (Multi-Ethnic Study of Atherosclerosis), Reynolds, and United Kingdom Prospective Diabetes Study risk scores.
The guidelines provide separate approaches to management of people at various ages. Another change from the 2012 guidelines is the establishment of acceptable and worrisome LDL-C levels in children: Acceptable is a level under 100 mg/dL, borderline is 100-129 mg/dL, and high is LDL-C at or above 130 mg/dL.
The guidelines, which will be published in full in the April issue of Endocrine Practice, are based largely on numerous clinical trials and studies, and in the end produced 87 recommendations, of which 45 are Grade A, 18 are Grade B, 15 are Grade C, and 9 are Grade D.
These are the first guidelines on lipid management from AACE since 2012. The executive summary of the guidelines is available at www.aace.com.
Dr. Jellinger reported receiving speakers honoraria from Amgen, AstraZeneca, BI-Lilly, Merck, and Novo Nordisk.
according to a summary by the American Association of Clinical Endocrinologists and American College of Endocrinology.
Achieving such a low LDL-cholesterol (LDL-C) level is possible with well-established medications such as a combination of simvastatin and ezetimibe and the newer, more clinically powerful agent PCSK9 inhibitors, Paul S. Jellinger, MD, chair of the guideline committee and professor of clinical medicine, University of Miami, said in an interview. The “extreme risk” category was derived largely from IMPROVE-IT and supporting meta-analyses.
The new category applies to patients with established atherosclerotic cardiovascular disease (ASCVD) who have any of the following risk factors:
• Progressive ASCVD including unstable angina after achieving an LDL-C level less than 70 mg/dL.
• Type 2 diabetes mellitus, chronic kidney disease stage 3 or 4, or heterozygous familial hypercholesterolemia.
• A history of premature ASCVD (before age 55 years in men, 65 years in women).
Heterozygous hypercholesterolemia is more common than many physicians realize, affecting as it does 1 in 250 people, Dr. Jellinger noted.
“Supporting evidence for the ‘extreme risk’ category with an LDL-C of less than 55 mg/dL was recently announced with the top line results from the FOURIER CVD outcome trial utilizing PCSK9-inhibitor therapy, which met both its primary and secondary endpoints,” he stressed.
PCSK9 inhibitors are extremely expensive, said Dr. Jellinger. “In my view, payers should not be denying patients who clearly meet the Food and Drug Administration approved indications for PCSK9 inhibitors and those within the extreme risk criteria. Yet, I have been made aware that 80% of insurance claims for PCSK9 inhibitors in these extremely high-risk and vulnerable patients are being denied.”
Inclusion in the updated AACE lipid management guidelines should strengthen PCSK9 inhibitors’ place among lipid-lowering drugs that are acceptable to insurance companies by making it clear that PCSK9 is appropriate and indicated for select patients, according to Dr. Jellinger.
Aside from creation of the extreme risk category, the AACE lipid guidelines discuss the available tools for making a global risk assessment of having a cardiac, vascular, or stroke event in the next 10 years, without favoring any one risk score. Among the systems discussed, with links, are the Framingham, MESA (Multi-Ethnic Study of Atherosclerosis), Reynolds, and United Kingdom Prospective Diabetes Study risk scores.
The guidelines provide separate approaches to management of people at various ages. Another change from the 2012 guidelines is the establishment of acceptable and worrisome LDL-C levels in children: Acceptable is a level under 100 mg/dL, borderline is 100-129 mg/dL, and high is LDL-C at or above 130 mg/dL.
The guidelines, which will be published in full in the April issue of Endocrine Practice, are based largely on numerous clinical trials and studies, and in the end produced 87 recommendations, of which 45 are Grade A, 18 are Grade B, 15 are Grade C, and 9 are Grade D.
These are the first guidelines on lipid management from AACE since 2012. The executive summary of the guidelines is available at www.aace.com.
Dr. Jellinger reported receiving speakers honoraria from Amgen, AstraZeneca, BI-Lilly, Merck, and Novo Nordisk.
according to a summary by the American Association of Clinical Endocrinologists and American College of Endocrinology.
Achieving such a low LDL-cholesterol (LDL-C) level is possible with well-established medications such as a combination of simvastatin and ezetimibe and the newer, more clinically powerful agent PCSK9 inhibitors, Paul S. Jellinger, MD, chair of the guideline committee and professor of clinical medicine, University of Miami, said in an interview. The “extreme risk” category was derived largely from IMPROVE-IT and supporting meta-analyses.
The new category applies to patients with established atherosclerotic cardiovascular disease (ASCVD) who have any of the following risk factors:
• Progressive ASCVD including unstable angina after achieving an LDL-C level less than 70 mg/dL.
• Type 2 diabetes mellitus, chronic kidney disease stage 3 or 4, or heterozygous familial hypercholesterolemia.
• A history of premature ASCVD (before age 55 years in men, 65 years in women).
Heterozygous hypercholesterolemia is more common than many physicians realize, affecting as it does 1 in 250 people, Dr. Jellinger noted.
“Supporting evidence for the ‘extreme risk’ category with an LDL-C of less than 55 mg/dL was recently announced with the top line results from the FOURIER CVD outcome trial utilizing PCSK9-inhibitor therapy, which met both its primary and secondary endpoints,” he stressed.
PCSK9 inhibitors are extremely expensive, said Dr. Jellinger. “In my view, payers should not be denying patients who clearly meet the Food and Drug Administration approved indications for PCSK9 inhibitors and those within the extreme risk criteria. Yet, I have been made aware that 80% of insurance claims for PCSK9 inhibitors in these extremely high-risk and vulnerable patients are being denied.”
Inclusion in the updated AACE lipid management guidelines should strengthen PCSK9 inhibitors’ place among lipid-lowering drugs that are acceptable to insurance companies by making it clear that PCSK9 is appropriate and indicated for select patients, according to Dr. Jellinger.
Aside from creation of the extreme risk category, the AACE lipid guidelines discuss the available tools for making a global risk assessment of having a cardiac, vascular, or stroke event in the next 10 years, without favoring any one risk score. Among the systems discussed, with links, are the Framingham, MESA (Multi-Ethnic Study of Atherosclerosis), Reynolds, and United Kingdom Prospective Diabetes Study risk scores.
The guidelines provide separate approaches to management of people at various ages. Another change from the 2012 guidelines is the establishment of acceptable and worrisome LDL-C levels in children: Acceptable is a level under 100 mg/dL, borderline is 100-129 mg/dL, and high is LDL-C at or above 130 mg/dL.
The guidelines, which will be published in full in the April issue of Endocrine Practice, are based largely on numerous clinical trials and studies, and in the end produced 87 recommendations, of which 45 are Grade A, 18 are Grade B, 15 are Grade C, and 9 are Grade D.
These are the first guidelines on lipid management from AACE since 2012. The executive summary of the guidelines is available at www.aace.com.
Dr. Jellinger reported receiving speakers honoraria from Amgen, AstraZeneca, BI-Lilly, Merck, and Novo Nordisk.
Endocrine Society to the White House: Immigration ban undermines science
The immigration ban from seven Muslim-majority countries issued recently by the Trump administration is having the unintended effect of disrupting scientific collaboration, according to a statement issued by the Endocrine Society.
“President Donald Trump’s order instituting a temporary travel ban from certain countries will greatly impact knowledge sharing among doctors and researchers and ultimately adversely affect patient care, Henry M. Kronenberg, MD, Endocrine Society president, wrote in a press release. “Science, at its core, is a global endeavor.”
Gary D. Hammer, MD, PhD, program chair of this year’s meeting, which is scheduled to take place April 1-4 in Orlando, said in an interview that he had received an email from a colleague in Iran, one of the seven targeted countries, immediately after imposition of the temporary travel ban. That endocrinologist, along with his fellow Iranian colleagues, had airline tickets and hotel rooms, and had invested in meeting fees and other upfront expenses, leaving them all with the question of what to do now. “He was prepared to come but now can’t due to the travel ban,” said Dr. Hammer, Millie Schembechler Professor of Adrenal Cancer at the University of Michigan in Ann Arbor, Mich. That email was the start of the Endocrine Society’s early action to address the ban, he noted. “I relayed the concern to Dr. Kronenberg and associated society leadership, who agreed that this is a pressing issue that must be addressed immediately,” Dr. Hammer said.
Another colleague, a woman from Sudan now living in the Netherlands on a visa, is, concerned too, that she would be turned away because her passport is issued by Sudan. She will not be attending the meeting, either. And another colleague not a citizen of one of the seven countries or even a western European descendant of relatives from there, called to say he would not be coming because of concern about the “increased challenge” of trying to enter the United States from Europe. “The ripple effect of this executive action has instilled fear across the globe, regardless of where they live,” Dr. Hammer said of clinical endocrinologists and endocrine scientists reluctant to come to the Endocrine Society’s annual meeting.
“The Endocrine Society is a global organization with 18,000 members in 122 countries, including some singled out by the travel ban,” the press release said. In fact, 40% of members of the Endocrine Society live outside the United States, a fact that underscores the collaborative nature of scientific research, clinical advances, and education in endocrinology.
In Dr. Hammer’s own area of expertise – endocrine cancers – advances in research and clinical management are made only when scientists come from around the world to pool their rare genetic resources and experience to make breakthroughs. “It often takes decades to develop international collaborations,” he said. Some endocrine cancers and other endocrine diseases are quite rare. Relying on cases just in the United States would make it less likely that there would be therapeutic advances, he said.
“Clinical care advances only through the application of science, and this effort is inherently global,” Dr. Hammer stressed.
cenews@frontlinemedcom.com
The immigration ban from seven Muslim-majority countries issued recently by the Trump administration is having the unintended effect of disrupting scientific collaboration, according to a statement issued by the Endocrine Society.
“President Donald Trump’s order instituting a temporary travel ban from certain countries will greatly impact knowledge sharing among doctors and researchers and ultimately adversely affect patient care, Henry M. Kronenberg, MD, Endocrine Society president, wrote in a press release. “Science, at its core, is a global endeavor.”
Gary D. Hammer, MD, PhD, program chair of this year’s meeting, which is scheduled to take place April 1-4 in Orlando, said in an interview that he had received an email from a colleague in Iran, one of the seven targeted countries, immediately after imposition of the temporary travel ban. That endocrinologist, along with his fellow Iranian colleagues, had airline tickets and hotel rooms, and had invested in meeting fees and other upfront expenses, leaving them all with the question of what to do now. “He was prepared to come but now can’t due to the travel ban,” said Dr. Hammer, Millie Schembechler Professor of Adrenal Cancer at the University of Michigan in Ann Arbor, Mich. That email was the start of the Endocrine Society’s early action to address the ban, he noted. “I relayed the concern to Dr. Kronenberg and associated society leadership, who agreed that this is a pressing issue that must be addressed immediately,” Dr. Hammer said.
Another colleague, a woman from Sudan now living in the Netherlands on a visa, is, concerned too, that she would be turned away because her passport is issued by Sudan. She will not be attending the meeting, either. And another colleague not a citizen of one of the seven countries or even a western European descendant of relatives from there, called to say he would not be coming because of concern about the “increased challenge” of trying to enter the United States from Europe. “The ripple effect of this executive action has instilled fear across the globe, regardless of where they live,” Dr. Hammer said of clinical endocrinologists and endocrine scientists reluctant to come to the Endocrine Society’s annual meeting.
“The Endocrine Society is a global organization with 18,000 members in 122 countries, including some singled out by the travel ban,” the press release said. In fact, 40% of members of the Endocrine Society live outside the United States, a fact that underscores the collaborative nature of scientific research, clinical advances, and education in endocrinology.
In Dr. Hammer’s own area of expertise – endocrine cancers – advances in research and clinical management are made only when scientists come from around the world to pool their rare genetic resources and experience to make breakthroughs. “It often takes decades to develop international collaborations,” he said. Some endocrine cancers and other endocrine diseases are quite rare. Relying on cases just in the United States would make it less likely that there would be therapeutic advances, he said.
“Clinical care advances only through the application of science, and this effort is inherently global,” Dr. Hammer stressed.
cenews@frontlinemedcom.com
The immigration ban from seven Muslim-majority countries issued recently by the Trump administration is having the unintended effect of disrupting scientific collaboration, according to a statement issued by the Endocrine Society.
“President Donald Trump’s order instituting a temporary travel ban from certain countries will greatly impact knowledge sharing among doctors and researchers and ultimately adversely affect patient care, Henry M. Kronenberg, MD, Endocrine Society president, wrote in a press release. “Science, at its core, is a global endeavor.”
Gary D. Hammer, MD, PhD, program chair of this year’s meeting, which is scheduled to take place April 1-4 in Orlando, said in an interview that he had received an email from a colleague in Iran, one of the seven targeted countries, immediately after imposition of the temporary travel ban. That endocrinologist, along with his fellow Iranian colleagues, had airline tickets and hotel rooms, and had invested in meeting fees and other upfront expenses, leaving them all with the question of what to do now. “He was prepared to come but now can’t due to the travel ban,” said Dr. Hammer, Millie Schembechler Professor of Adrenal Cancer at the University of Michigan in Ann Arbor, Mich. That email was the start of the Endocrine Society’s early action to address the ban, he noted. “I relayed the concern to Dr. Kronenberg and associated society leadership, who agreed that this is a pressing issue that must be addressed immediately,” Dr. Hammer said.
Another colleague, a woman from Sudan now living in the Netherlands on a visa, is, concerned too, that she would be turned away because her passport is issued by Sudan. She will not be attending the meeting, either. And another colleague not a citizen of one of the seven countries or even a western European descendant of relatives from there, called to say he would not be coming because of concern about the “increased challenge” of trying to enter the United States from Europe. “The ripple effect of this executive action has instilled fear across the globe, regardless of where they live,” Dr. Hammer said of clinical endocrinologists and endocrine scientists reluctant to come to the Endocrine Society’s annual meeting.
“The Endocrine Society is a global organization with 18,000 members in 122 countries, including some singled out by the travel ban,” the press release said. In fact, 40% of members of the Endocrine Society live outside the United States, a fact that underscores the collaborative nature of scientific research, clinical advances, and education in endocrinology.
In Dr. Hammer’s own area of expertise – endocrine cancers – advances in research and clinical management are made only when scientists come from around the world to pool their rare genetic resources and experience to make breakthroughs. “It often takes decades to develop international collaborations,” he said. Some endocrine cancers and other endocrine diseases are quite rare. Relying on cases just in the United States would make it less likely that there would be therapeutic advances, he said.
“Clinical care advances only through the application of science, and this effort is inherently global,” Dr. Hammer stressed.
cenews@frontlinemedcom.com
FROM THE ENDOCRINE SOCIETY
FDA expands indication for continuous glucose monitoring system
People with diabetes have come a step closer to a life without multiple daily finger sticks. The with diabetes, the Food and Drug Administration announced .
“Although this system still requires calibration with two daily fingersticks, it eliminates the need for any additional fingerstick blood glucose testing in order to make treatment decisions,” Alberto Gutierrez, Ph.D., director of the office of in vitro diagnostics and radiological health in the FDA’s Center for Devices and Radiological Health, said in the FDA statement.
The FDA based its decision on data from two clinical studies of 130 adults and children aged 2 years and older with diabetes. No serious adverse events were reported during a 7-day period when system readings were compared with blood glucose meter values and lab glucose measures.
The action comes just a few months after the agency approved the MiniMed 670G by Medtronic, a hybrid closed-loop system designed to automatically monitor glucose and deliver appropriate basal insulin doses in patients aged 14 years and older. Medtronic is currently evaluating the safety and efficacy of the device in children aged 7-13 years.
People with diabetes have come a step closer to a life without multiple daily finger sticks. The with diabetes, the Food and Drug Administration announced .
“Although this system still requires calibration with two daily fingersticks, it eliminates the need for any additional fingerstick blood glucose testing in order to make treatment decisions,” Alberto Gutierrez, Ph.D., director of the office of in vitro diagnostics and radiological health in the FDA’s Center for Devices and Radiological Health, said in the FDA statement.
The FDA based its decision on data from two clinical studies of 130 adults and children aged 2 years and older with diabetes. No serious adverse events were reported during a 7-day period when system readings were compared with blood glucose meter values and lab glucose measures.
The action comes just a few months after the agency approved the MiniMed 670G by Medtronic, a hybrid closed-loop system designed to automatically monitor glucose and deliver appropriate basal insulin doses in patients aged 14 years and older. Medtronic is currently evaluating the safety and efficacy of the device in children aged 7-13 years.
People with diabetes have come a step closer to a life without multiple daily finger sticks. The with diabetes, the Food and Drug Administration announced .
“Although this system still requires calibration with two daily fingersticks, it eliminates the need for any additional fingerstick blood glucose testing in order to make treatment decisions,” Alberto Gutierrez, Ph.D., director of the office of in vitro diagnostics and radiological health in the FDA’s Center for Devices and Radiological Health, said in the FDA statement.
The FDA based its decision on data from two clinical studies of 130 adults and children aged 2 years and older with diabetes. No serious adverse events were reported during a 7-day period when system readings were compared with blood glucose meter values and lab glucose measures.
The action comes just a few months after the agency approved the MiniMed 670G by Medtronic, a hybrid closed-loop system designed to automatically monitor glucose and deliver appropriate basal insulin doses in patients aged 14 years and older. Medtronic is currently evaluating the safety and efficacy of the device in children aged 7-13 years.
XR version of Synjardy gets FDA’s nod
for use in the management of blood sugar in adults with type 2 diabetes. The drug, to be marketed as Synjardy XR by Boehringer Ingelheim and Eli Lilly, is intended for use with a diet and exercise program.
Its standard release formulation was approved in August 2015.
FDA approved the extended-release version on Dec. 12. The updated label includes a boxed warning regarding the risk of metformin-associated lactic acidosis
Empagliflozin recently received an FDA indication as a medication for use in reducing the risk of cardiovascular death in patients with type 2 diabetes and concomitant cardiovascular disease, the first drug for type 2 diabetes to do so.
The label includes information of the drug’s four doses, all of which contain 1,000 mg of metformin plus empagliflozin in strengths of 5 mg, 10 mg, 12.5 mg, and 25 mg.
Among patients who are already taking metformin and plan to begin a regimen of Synjardy XR, their best choice is to switch to the formulation containing a similar daily dose of metformin and a total daily dose of 10 mg empagliflozin. Those already on empagliflozin should switch to Synjardy XR containing the same daily dose of empagliflozin and a total daily dose of 1,000 mg metformin. Dosing may be adjusted upward on the basis of effectiveness and tolerability up to a maximum of 25 mg empagliflozin/2,000 mg metformin, taken once daily with a meal in the morning.
Synjardy XR is contraindicated in patients with an estimated glomerular filtration rate of less than 45 mL/min per 1.73 m2. Renal function should be assessed in patients with impaired renal function before taking Synjardy XR.
Several clinical trials tested coadministration of metformin and empagliflozin. In the largest, 637 patients with type 2 diabetes who were inadequately controlled (hemoglobin A1c of 7%-10%) with 1,500 mg metformin were randomized to receive placebo, 10 mg empagliflozin, or 25 mg empagliflozin for 24 weeks. Both the 10-mg and 25-mg dosages of empagliflozin resulted in significant reductions compared with placebo in HbA1c (–0.7% and –0.8%, respectively) fasting glucose (–26 mg/dL and –29 mg/dL), and body weight (–2 kg and –2.5 kg).
The single-pill formulation of Synjardy XR was not tested in clinical trials for efficacy; however, several trials performed in healthy subjects showed bioequivalence of the fixed dose combination, compared with separate pills.
skubetin@frontlinemedcom.com
for use in the management of blood sugar in adults with type 2 diabetes. The drug, to be marketed as Synjardy XR by Boehringer Ingelheim and Eli Lilly, is intended for use with a diet and exercise program.
Its standard release formulation was approved in August 2015.
FDA approved the extended-release version on Dec. 12. The updated label includes a boxed warning regarding the risk of metformin-associated lactic acidosis
Empagliflozin recently received an FDA indication as a medication for use in reducing the risk of cardiovascular death in patients with type 2 diabetes and concomitant cardiovascular disease, the first drug for type 2 diabetes to do so.
The label includes information of the drug’s four doses, all of which contain 1,000 mg of metformin plus empagliflozin in strengths of 5 mg, 10 mg, 12.5 mg, and 25 mg.
Among patients who are already taking metformin and plan to begin a regimen of Synjardy XR, their best choice is to switch to the formulation containing a similar daily dose of metformin and a total daily dose of 10 mg empagliflozin. Those already on empagliflozin should switch to Synjardy XR containing the same daily dose of empagliflozin and a total daily dose of 1,000 mg metformin. Dosing may be adjusted upward on the basis of effectiveness and tolerability up to a maximum of 25 mg empagliflozin/2,000 mg metformin, taken once daily with a meal in the morning.
Synjardy XR is contraindicated in patients with an estimated glomerular filtration rate of less than 45 mL/min per 1.73 m2. Renal function should be assessed in patients with impaired renal function before taking Synjardy XR.
Several clinical trials tested coadministration of metformin and empagliflozin. In the largest, 637 patients with type 2 diabetes who were inadequately controlled (hemoglobin A1c of 7%-10%) with 1,500 mg metformin were randomized to receive placebo, 10 mg empagliflozin, or 25 mg empagliflozin for 24 weeks. Both the 10-mg and 25-mg dosages of empagliflozin resulted in significant reductions compared with placebo in HbA1c (–0.7% and –0.8%, respectively) fasting glucose (–26 mg/dL and –29 mg/dL), and body weight (–2 kg and –2.5 kg).
The single-pill formulation of Synjardy XR was not tested in clinical trials for efficacy; however, several trials performed in healthy subjects showed bioequivalence of the fixed dose combination, compared with separate pills.
skubetin@frontlinemedcom.com
for use in the management of blood sugar in adults with type 2 diabetes. The drug, to be marketed as Synjardy XR by Boehringer Ingelheim and Eli Lilly, is intended for use with a diet and exercise program.
Its standard release formulation was approved in August 2015.
FDA approved the extended-release version on Dec. 12. The updated label includes a boxed warning regarding the risk of metformin-associated lactic acidosis
Empagliflozin recently received an FDA indication as a medication for use in reducing the risk of cardiovascular death in patients with type 2 diabetes and concomitant cardiovascular disease, the first drug for type 2 diabetes to do so.
The label includes information of the drug’s four doses, all of which contain 1,000 mg of metformin plus empagliflozin in strengths of 5 mg, 10 mg, 12.5 mg, and 25 mg.
Among patients who are already taking metformin and plan to begin a regimen of Synjardy XR, their best choice is to switch to the formulation containing a similar daily dose of metformin and a total daily dose of 10 mg empagliflozin. Those already on empagliflozin should switch to Synjardy XR containing the same daily dose of empagliflozin and a total daily dose of 1,000 mg metformin. Dosing may be adjusted upward on the basis of effectiveness and tolerability up to a maximum of 25 mg empagliflozin/2,000 mg metformin, taken once daily with a meal in the morning.
Synjardy XR is contraindicated in patients with an estimated glomerular filtration rate of less than 45 mL/min per 1.73 m2. Renal function should be assessed in patients with impaired renal function before taking Synjardy XR.
Several clinical trials tested coadministration of metformin and empagliflozin. In the largest, 637 patients with type 2 diabetes who were inadequately controlled (hemoglobin A1c of 7%-10%) with 1,500 mg metformin were randomized to receive placebo, 10 mg empagliflozin, or 25 mg empagliflozin for 24 weeks. Both the 10-mg and 25-mg dosages of empagliflozin resulted in significant reductions compared with placebo in HbA1c (–0.7% and –0.8%, respectively) fasting glucose (–26 mg/dL and –29 mg/dL), and body weight (–2 kg and –2.5 kg).
The single-pill formulation of Synjardy XR was not tested in clinical trials for efficacy; however, several trials performed in healthy subjects showed bioequivalence of the fixed dose combination, compared with separate pills.
skubetin@frontlinemedcom.com
ATA’s risk assessment guidelines for thyroid nodules using sonography patterns validated
DENVER – The malignancy risk of thyroid nodules can be assessed with reassuring accuracy using ultrasound and the guidelines developed by the American Thyroid Association.
Ultrasound assessment is the first step of the evaluation of any patient with one or more thyroid nodules. “Maybe it shouldn’t be, but, for now, it is,” noted David L. Steward, MD, at the annual meeting of the American Thyroid Association.
The ATA guidelines categorize thyroid nodules on the basis of their ultrasound patterns, with the high risk of malignancy being in nodules that are taller than they are wide and /or have microcalcifications, irregular margins, hypoechoic areas, extrathyroidal extension, interrupted rim calcification with soft tissue extrusion, and suspicious lymph nodes. Between 70% and 90% of thyroids with such patterns will contain malignancy, according to the ATA guidelines. Lesions with an intermediate risk of malignancy have such sonographic findings as hypoechoic solid tissue and regular margins; between 10% and 20% of these are malignant. The third category in the ATA’s guidelines are those that are of low suspicion, with hyperechoic solid tissue, isoechoic solid tissue, partially cystic with eccentric solid area, and regular margins; 5%-10% of these are malignant. Thyroid nodules with a very-low risk of malignancy (less than 3%) are spongiform or partially cystic with no suspicious findings. Finally, benign nodules, of which less than 1% contain malignancy, are cysts, he said.
“We found that the size of the nodule on ultrasound that underwent fine needle aspiration was inversely correlated with malignancy risk: The lower risk nodules were larger,” he said.
Using the ATA’s system, 9 (4%) of the nodules were high risk, 64 (31%) were intermediate risk, 79 (38%) were low risk, 54 (26%) were very-low risk, and none were benign. Five of the nodules were not included in the results presented.
There was good correlation between the Bethesda and ATA classification systems. Of the lesions that were malignant or suspicious for malignancy in the Bethesda system, 77% were very-high risk for malignancy on ultrasound according to the ATA. Of the lesions that were atypia of undetermined significance (AUS)/follicular lesion of undetermined significance (FLUS), 22% were very high risk according to the ATA. Neither of the systems classified as malignant any of the lesions as follicular/Hurthle cell cancer, benign, or nondiagnostic.
The AUS/FLUS nodules “tend to be all over the map,” he noted. Looking at just the AUS/FLUS nodules, malignancy was found on pathology in 100% classified by the ATA system as being high risk; in 21% of those called intermediate risk; in 17% of those called low risk; and in 12% of the very-low risk group.
The study was funded by the University of Cincinnati. Dr. Steward said his only disclosure is that he was a member of the ATA committee that wrote the guidelines under evaluation in this study.
DENVER – The malignancy risk of thyroid nodules can be assessed with reassuring accuracy using ultrasound and the guidelines developed by the American Thyroid Association.
Ultrasound assessment is the first step of the evaluation of any patient with one or more thyroid nodules. “Maybe it shouldn’t be, but, for now, it is,” noted David L. Steward, MD, at the annual meeting of the American Thyroid Association.
The ATA guidelines categorize thyroid nodules on the basis of their ultrasound patterns, with the high risk of malignancy being in nodules that are taller than they are wide and /or have microcalcifications, irregular margins, hypoechoic areas, extrathyroidal extension, interrupted rim calcification with soft tissue extrusion, and suspicious lymph nodes. Between 70% and 90% of thyroids with such patterns will contain malignancy, according to the ATA guidelines. Lesions with an intermediate risk of malignancy have such sonographic findings as hypoechoic solid tissue and regular margins; between 10% and 20% of these are malignant. The third category in the ATA’s guidelines are those that are of low suspicion, with hyperechoic solid tissue, isoechoic solid tissue, partially cystic with eccentric solid area, and regular margins; 5%-10% of these are malignant. Thyroid nodules with a very-low risk of malignancy (less than 3%) are spongiform or partially cystic with no suspicious findings. Finally, benign nodules, of which less than 1% contain malignancy, are cysts, he said.
“We found that the size of the nodule on ultrasound that underwent fine needle aspiration was inversely correlated with malignancy risk: The lower risk nodules were larger,” he said.
Using the ATA’s system, 9 (4%) of the nodules were high risk, 64 (31%) were intermediate risk, 79 (38%) were low risk, 54 (26%) were very-low risk, and none were benign. Five of the nodules were not included in the results presented.
There was good correlation between the Bethesda and ATA classification systems. Of the lesions that were malignant or suspicious for malignancy in the Bethesda system, 77% were very-high risk for malignancy on ultrasound according to the ATA. Of the lesions that were atypia of undetermined significance (AUS)/follicular lesion of undetermined significance (FLUS), 22% were very high risk according to the ATA. Neither of the systems classified as malignant any of the lesions as follicular/Hurthle cell cancer, benign, or nondiagnostic.
The AUS/FLUS nodules “tend to be all over the map,” he noted. Looking at just the AUS/FLUS nodules, malignancy was found on pathology in 100% classified by the ATA system as being high risk; in 21% of those called intermediate risk; in 17% of those called low risk; and in 12% of the very-low risk group.
The study was funded by the University of Cincinnati. Dr. Steward said his only disclosure is that he was a member of the ATA committee that wrote the guidelines under evaluation in this study.
DENVER – The malignancy risk of thyroid nodules can be assessed with reassuring accuracy using ultrasound and the guidelines developed by the American Thyroid Association.
Ultrasound assessment is the first step of the evaluation of any patient with one or more thyroid nodules. “Maybe it shouldn’t be, but, for now, it is,” noted David L. Steward, MD, at the annual meeting of the American Thyroid Association.
The ATA guidelines categorize thyroid nodules on the basis of their ultrasound patterns, with the high risk of malignancy being in nodules that are taller than they are wide and /or have microcalcifications, irregular margins, hypoechoic areas, extrathyroidal extension, interrupted rim calcification with soft tissue extrusion, and suspicious lymph nodes. Between 70% and 90% of thyroids with such patterns will contain malignancy, according to the ATA guidelines. Lesions with an intermediate risk of malignancy have such sonographic findings as hypoechoic solid tissue and regular margins; between 10% and 20% of these are malignant. The third category in the ATA’s guidelines are those that are of low suspicion, with hyperechoic solid tissue, isoechoic solid tissue, partially cystic with eccentric solid area, and regular margins; 5%-10% of these are malignant. Thyroid nodules with a very-low risk of malignancy (less than 3%) are spongiform or partially cystic with no suspicious findings. Finally, benign nodules, of which less than 1% contain malignancy, are cysts, he said.
“We found that the size of the nodule on ultrasound that underwent fine needle aspiration was inversely correlated with malignancy risk: The lower risk nodules were larger,” he said.
Using the ATA’s system, 9 (4%) of the nodules were high risk, 64 (31%) were intermediate risk, 79 (38%) were low risk, 54 (26%) were very-low risk, and none were benign. Five of the nodules were not included in the results presented.
There was good correlation between the Bethesda and ATA classification systems. Of the lesions that were malignant or suspicious for malignancy in the Bethesda system, 77% were very-high risk for malignancy on ultrasound according to the ATA. Of the lesions that were atypia of undetermined significance (AUS)/follicular lesion of undetermined significance (FLUS), 22% were very high risk according to the ATA. Neither of the systems classified as malignant any of the lesions as follicular/Hurthle cell cancer, benign, or nondiagnostic.
The AUS/FLUS nodules “tend to be all over the map,” he noted. Looking at just the AUS/FLUS nodules, malignancy was found on pathology in 100% classified by the ATA system as being high risk; in 21% of those called intermediate risk; in 17% of those called low risk; and in 12% of the very-low risk group.
The study was funded by the University of Cincinnati. Dr. Steward said his only disclosure is that he was a member of the ATA committee that wrote the guidelines under evaluation in this study.
Key clinical point:
Major finding: Of the lesions that were malignant or suspicious for malignancy in the Bethesda system, 77% were very-high risk for malignancy on ultrasound, according to the ATA.
Data source: Prospective validation of the ATA’s ultrasound risk assessment guidelines on 211 thyroid nodules excised from 199 patients.
Disclosures: The study was funded by the University of Cincinnati. Dr. Steward said his only disclosure is that he was a member of the ATA committee that wrote the guidelines under evaluation in this study.
Hot flashes and sleep disruption contribute independently to depression in menopause
Hot flashes and sleep disruption contribute independently to the development of depression in menopause, judging from the findings of a recent study.
In that study, 29 premenopausal women, aged 18-45 years, received a single dose of the GnRH agonist leuprolide in order to induce hypoestrogenism and ovarian suppression for the study period. The women in the study had no history of primary sleep disturbances, low estrogen levels, or depression, according to Hadine Joffe, MD, director of the Women’s Hormone and Aging Research Program at Harvard Medical School, in Boston, and her associates.
All the study participants underwent baseline mood evaluation using both the Montgomery-Asberg Depression Rating Scale (MADRS) and the Beck Depression Inventory (BDI). Existing sleep disturbances were ruled out at baseline with sleep diaries, questionnaires, and two ambulatory screening polysomnography (PSG) studies.
After 4 weeks of administration of leuprolide, depressive symptoms had developed among most of the women in the study. The mean MADRS score was 4.1, and overall, it was 3.1 points higher than it had been at baseline. One woman had a 15-point increase in her score, suggesting significant depression. The MADRS score increased by at least 5 points in 24% of the women and remained unchanged in 38%, reflecting variability among the women on the impact of leuprolide on depressive symptoms, the investigators reported (J Clin Endocrinol Metab. 2016 Sep 20. doi: 10.1210/jc.2016-2348).
Leuprolide universally suppressed estradiol to postmenopausal levels in the women within 2 weeks. Hot flashes developed in 20 (69%) women, with a median of 3.6 hot flashes during the day and 3.8 at night. The median number of objectively measured nighttime hot flashes per night was 3.
Changes to sleep patterns varied widely for each woman; for example, wake time after sleep onset ranged from an additional 140 minutes to 23 fewer minutes for one woman. There was a correlation between the number of subjectively reported nighttime hot flashes with increased sleep fragmentation as measured by PSG. The number of reported nighttime hot flashes was associated with an increase in depressive symptoms that was disproportionate to the number of nighttime hot flashes reported, according to the findings of a univariate analysis. The number of daytime hot flashes had no such effect.
In light of these findings, Dr. Joffe and her associates urged clinicians to screen women who report nighttime hot flashes and sleep interruption for mood disturbance. “Treatment of those with menopause-related depressive symptoms should encompass therapies that improve sleep interruption as well as nocturnal [hot flashes],” they wrote.
The study was sponsored by the National Institute of Mental Health. Dr. Joffe has received grant support from Merck and has served as a consultant/adviser for Merck, Mitsubishi Tanabe, NeRRe Therapeutics, and Noven.
Hot flashes and sleep disruption contribute independently to the development of depression in menopause, judging from the findings of a recent study.
In that study, 29 premenopausal women, aged 18-45 years, received a single dose of the GnRH agonist leuprolide in order to induce hypoestrogenism and ovarian suppression for the study period. The women in the study had no history of primary sleep disturbances, low estrogen levels, or depression, according to Hadine Joffe, MD, director of the Women’s Hormone and Aging Research Program at Harvard Medical School, in Boston, and her associates.
All the study participants underwent baseline mood evaluation using both the Montgomery-Asberg Depression Rating Scale (MADRS) and the Beck Depression Inventory (BDI). Existing sleep disturbances were ruled out at baseline with sleep diaries, questionnaires, and two ambulatory screening polysomnography (PSG) studies.
After 4 weeks of administration of leuprolide, depressive symptoms had developed among most of the women in the study. The mean MADRS score was 4.1, and overall, it was 3.1 points higher than it had been at baseline. One woman had a 15-point increase in her score, suggesting significant depression. The MADRS score increased by at least 5 points in 24% of the women and remained unchanged in 38%, reflecting variability among the women on the impact of leuprolide on depressive symptoms, the investigators reported (J Clin Endocrinol Metab. 2016 Sep 20. doi: 10.1210/jc.2016-2348).
Leuprolide universally suppressed estradiol to postmenopausal levels in the women within 2 weeks. Hot flashes developed in 20 (69%) women, with a median of 3.6 hot flashes during the day and 3.8 at night. The median number of objectively measured nighttime hot flashes per night was 3.
Changes to sleep patterns varied widely for each woman; for example, wake time after sleep onset ranged from an additional 140 minutes to 23 fewer minutes for one woman. There was a correlation between the number of subjectively reported nighttime hot flashes with increased sleep fragmentation as measured by PSG. The number of reported nighttime hot flashes was associated with an increase in depressive symptoms that was disproportionate to the number of nighttime hot flashes reported, according to the findings of a univariate analysis. The number of daytime hot flashes had no such effect.
In light of these findings, Dr. Joffe and her associates urged clinicians to screen women who report nighttime hot flashes and sleep interruption for mood disturbance. “Treatment of those with menopause-related depressive symptoms should encompass therapies that improve sleep interruption as well as nocturnal [hot flashes],” they wrote.
The study was sponsored by the National Institute of Mental Health. Dr. Joffe has received grant support from Merck and has served as a consultant/adviser for Merck, Mitsubishi Tanabe, NeRRe Therapeutics, and Noven.
Hot flashes and sleep disruption contribute independently to the development of depression in menopause, judging from the findings of a recent study.
In that study, 29 premenopausal women, aged 18-45 years, received a single dose of the GnRH agonist leuprolide in order to induce hypoestrogenism and ovarian suppression for the study period. The women in the study had no history of primary sleep disturbances, low estrogen levels, or depression, according to Hadine Joffe, MD, director of the Women’s Hormone and Aging Research Program at Harvard Medical School, in Boston, and her associates.
All the study participants underwent baseline mood evaluation using both the Montgomery-Asberg Depression Rating Scale (MADRS) and the Beck Depression Inventory (BDI). Existing sleep disturbances were ruled out at baseline with sleep diaries, questionnaires, and two ambulatory screening polysomnography (PSG) studies.
After 4 weeks of administration of leuprolide, depressive symptoms had developed among most of the women in the study. The mean MADRS score was 4.1, and overall, it was 3.1 points higher than it had been at baseline. One woman had a 15-point increase in her score, suggesting significant depression. The MADRS score increased by at least 5 points in 24% of the women and remained unchanged in 38%, reflecting variability among the women on the impact of leuprolide on depressive symptoms, the investigators reported (J Clin Endocrinol Metab. 2016 Sep 20. doi: 10.1210/jc.2016-2348).
Leuprolide universally suppressed estradiol to postmenopausal levels in the women within 2 weeks. Hot flashes developed in 20 (69%) women, with a median of 3.6 hot flashes during the day and 3.8 at night. The median number of objectively measured nighttime hot flashes per night was 3.
Changes to sleep patterns varied widely for each woman; for example, wake time after sleep onset ranged from an additional 140 minutes to 23 fewer minutes for one woman. There was a correlation between the number of subjectively reported nighttime hot flashes with increased sleep fragmentation as measured by PSG. The number of reported nighttime hot flashes was associated with an increase in depressive symptoms that was disproportionate to the number of nighttime hot flashes reported, according to the findings of a univariate analysis. The number of daytime hot flashes had no such effect.
In light of these findings, Dr. Joffe and her associates urged clinicians to screen women who report nighttime hot flashes and sleep interruption for mood disturbance. “Treatment of those with menopause-related depressive symptoms should encompass therapies that improve sleep interruption as well as nocturnal [hot flashes],” they wrote.
The study was sponsored by the National Institute of Mental Health. Dr. Joffe has received grant support from Merck and has served as a consultant/adviser for Merck, Mitsubishi Tanabe, NeRRe Therapeutics, and Noven.
FROM THE JOURNAL OF ENDOCRINOLOGY & METABOLISM
Key clinical point: Hot flashes and sleep disruption contribute independently to the development of depression in menopause.
Major finding: Depression scores increased by 3 points on the MADRS after 4 weeks on GnRH agonist leuprolide. Sleep disruption was also common among the women in the study. Depression developed among many, but not all the women, with univariate analysis showing that hot flashes and sleep disruption contributed independently to their mood changes.
Data source: A prospective study in which 29 young women without depression were subjected to rapid, premature, and reversible menopause with one open-label dose of leuprolide in an experimental model.
Disclosures: The study was sponsored by the National Institute of Mental Health. Dr. Hadine Joffe has received grant support from Merck and has served as a consultant/adviser for Merck, Mitsubishi Tanabe, NeRRe Therapeutics, and Noven.
Too many infants with congenital hypothyroidism go undetected, untreated
DENVER – An alarming percentage of infants born in Utah from 2006 to 2015 with primary congenital hypothyroidism were either lost to follow-up or inadequately treated.
If such a thing can happen in Utah with its highly functioning public health system, it probably can happen in the rest of the United States as well, Joel Ehrenkranz, MD, said at the American Thyroid Association annual meeting. “We just have not looked for it yet.”
Screening for and treating congenital hypothyroidism in infants is one of the great public health successes of the 20th century in the United States. It deserves to have the same level of importance as eradication of polio and smallpox in this country, noted Dr. Ehrenkranz, an endocrinologist in private practice in Glenwood Springs, Colo. At the time of this research, Dr. Ehrenkranz was with Intermountain Healthcare in Murray, Utah.
The American Academy of Pediatrics recommends diagnosis of congenital hypothyroidism by the 14th day of life and that the baby be biochemically euthyroid by week 6 (Pediatrics. 2006 June. doi: 10.1542/peds.2006-0915), he said.
The cohort included 4,394 children from birth to 24 months of age. The screening test was done by a third-generation bioluminescence serum TSH assay, not dried blood blot. Of these infants, 2% (82 babies) had a TSH level greater than or equal to 20 mIU/L at their initial test. That TSH was still high by day 14 in 42 infants (23 girls). But of all the babies with primary congenital hypothyroidism, 50% had a delayed diagnosis, he reported.
Twelve children (15%) were never retested; 34% reached AAP goals of having a TSH level less than 5 mIU/L within 28 days after starting treatment; half of the children with primary congenital hypothyropidism did not meet the treatment goal: “They were inadequately treated,” he said.
Of particular interest were 16 infants who had a TSH level of less than 20 mIU/L but on retesting had one of 20 or higher. Three of these infants had multiple TSH levels greater than 20, perhaps representing a subset with a late onset form of the disorder.
“We are not doing as well as we could do,” he said; 50% of affected babies have a delayed diagnosis with consequences of a delayed maturation of the pituitary thyroid axis. Logistics are a challenge. And 50% of babies did not meet treatment guidelines.
In comparison to the state of screening and management in Utah, moderator Alex S. Stagnaro-Green, MD, noted that many pediatricians and endocrinologists operate under the presumption that screening for primary congenital hypothyroidism is “a well-oiled machine and that these babies are being taken care of.”
Utah has a very functional public health infrastructure. Of note, Utah’s birth rate is the highest in the country. The birth rates in several of its counties rival the highest rates found in the world, according to Dr. Ehrenkranz.
“So I think we have a very significant problem nationwide that just hasn’t been looked at,” he noted in response to the question. He undertook looking at newborn TSH levels in the first place as part of a project with the Food and Drug Administration. It was only then that he and his associates were struck by how many babies had low serum TSH levels, he said.
He had no relevant financial relationships to disclose.
DENVER – An alarming percentage of infants born in Utah from 2006 to 2015 with primary congenital hypothyroidism were either lost to follow-up or inadequately treated.
If such a thing can happen in Utah with its highly functioning public health system, it probably can happen in the rest of the United States as well, Joel Ehrenkranz, MD, said at the American Thyroid Association annual meeting. “We just have not looked for it yet.”
Screening for and treating congenital hypothyroidism in infants is one of the great public health successes of the 20th century in the United States. It deserves to have the same level of importance as eradication of polio and smallpox in this country, noted Dr. Ehrenkranz, an endocrinologist in private practice in Glenwood Springs, Colo. At the time of this research, Dr. Ehrenkranz was with Intermountain Healthcare in Murray, Utah.
The American Academy of Pediatrics recommends diagnosis of congenital hypothyroidism by the 14th day of life and that the baby be biochemically euthyroid by week 6 (Pediatrics. 2006 June. doi: 10.1542/peds.2006-0915), he said.
The cohort included 4,394 children from birth to 24 months of age. The screening test was done by a third-generation bioluminescence serum TSH assay, not dried blood blot. Of these infants, 2% (82 babies) had a TSH level greater than or equal to 20 mIU/L at their initial test. That TSH was still high by day 14 in 42 infants (23 girls). But of all the babies with primary congenital hypothyroidism, 50% had a delayed diagnosis, he reported.
Twelve children (15%) were never retested; 34% reached AAP goals of having a TSH level less than 5 mIU/L within 28 days after starting treatment; half of the children with primary congenital hypothyropidism did not meet the treatment goal: “They were inadequately treated,” he said.
Of particular interest were 16 infants who had a TSH level of less than 20 mIU/L but on retesting had one of 20 or higher. Three of these infants had multiple TSH levels greater than 20, perhaps representing a subset with a late onset form of the disorder.
“We are not doing as well as we could do,” he said; 50% of affected babies have a delayed diagnosis with consequences of a delayed maturation of the pituitary thyroid axis. Logistics are a challenge. And 50% of babies did not meet treatment guidelines.
In comparison to the state of screening and management in Utah, moderator Alex S. Stagnaro-Green, MD, noted that many pediatricians and endocrinologists operate under the presumption that screening for primary congenital hypothyroidism is “a well-oiled machine and that these babies are being taken care of.”
Utah has a very functional public health infrastructure. Of note, Utah’s birth rate is the highest in the country. The birth rates in several of its counties rival the highest rates found in the world, according to Dr. Ehrenkranz.
“So I think we have a very significant problem nationwide that just hasn’t been looked at,” he noted in response to the question. He undertook looking at newborn TSH levels in the first place as part of a project with the Food and Drug Administration. It was only then that he and his associates were struck by how many babies had low serum TSH levels, he said.
He had no relevant financial relationships to disclose.
DENVER – An alarming percentage of infants born in Utah from 2006 to 2015 with primary congenital hypothyroidism were either lost to follow-up or inadequately treated.
If such a thing can happen in Utah with its highly functioning public health system, it probably can happen in the rest of the United States as well, Joel Ehrenkranz, MD, said at the American Thyroid Association annual meeting. “We just have not looked for it yet.”
Screening for and treating congenital hypothyroidism in infants is one of the great public health successes of the 20th century in the United States. It deserves to have the same level of importance as eradication of polio and smallpox in this country, noted Dr. Ehrenkranz, an endocrinologist in private practice in Glenwood Springs, Colo. At the time of this research, Dr. Ehrenkranz was with Intermountain Healthcare in Murray, Utah.
The American Academy of Pediatrics recommends diagnosis of congenital hypothyroidism by the 14th day of life and that the baby be biochemically euthyroid by week 6 (Pediatrics. 2006 June. doi: 10.1542/peds.2006-0915), he said.
The cohort included 4,394 children from birth to 24 months of age. The screening test was done by a third-generation bioluminescence serum TSH assay, not dried blood blot. Of these infants, 2% (82 babies) had a TSH level greater than or equal to 20 mIU/L at their initial test. That TSH was still high by day 14 in 42 infants (23 girls). But of all the babies with primary congenital hypothyroidism, 50% had a delayed diagnosis, he reported.
Twelve children (15%) were never retested; 34% reached AAP goals of having a TSH level less than 5 mIU/L within 28 days after starting treatment; half of the children with primary congenital hypothyropidism did not meet the treatment goal: “They were inadequately treated,” he said.
Of particular interest were 16 infants who had a TSH level of less than 20 mIU/L but on retesting had one of 20 or higher. Three of these infants had multiple TSH levels greater than 20, perhaps representing a subset with a late onset form of the disorder.
“We are not doing as well as we could do,” he said; 50% of affected babies have a delayed diagnosis with consequences of a delayed maturation of the pituitary thyroid axis. Logistics are a challenge. And 50% of babies did not meet treatment guidelines.
In comparison to the state of screening and management in Utah, moderator Alex S. Stagnaro-Green, MD, noted that many pediatricians and endocrinologists operate under the presumption that screening for primary congenital hypothyroidism is “a well-oiled machine and that these babies are being taken care of.”
Utah has a very functional public health infrastructure. Of note, Utah’s birth rate is the highest in the country. The birth rates in several of its counties rival the highest rates found in the world, according to Dr. Ehrenkranz.
“So I think we have a very significant problem nationwide that just hasn’t been looked at,” he noted in response to the question. He undertook looking at newborn TSH levels in the first place as part of a project with the Food and Drug Administration. It was only then that he and his associates were struck by how many babies had low serum TSH levels, he said.
He had no relevant financial relationships to disclose.
AT THE ATA ANNUAL MEETING
Key clinical point: A large percentage of babies with congenital hypothyroidism are falling through the cracks in Utah, and likely throughout the United States.
Major finding: Almost 2% of 4,395 babies had TSH levels equal to or above 20 mIU/L when assessed after birth; of those, a significant share were lost to follow-up or inadequately treated.
Data source: A review of TSH measurements in all babies born in Utah between 2006 and 2015.
Disclosures: Dr. Ehrenkranz had no relevant financial disclosures.
The thyroid takes a beating during PCI in about 3% of patients
DENVER – Undergoing percutaneous coronary intervention (PCI) may impair thyroid function and change the gland’s morphology, probably because of the cumulative effects of handling and exposure to radiation and iodine in the contrast dye, Samir Naim Assaad, MD, said during a poster presentation at the annual meeting of the American Thyroid Association.
Cardiologists should inform their patients of these possible effects as part of their pre- and post-PCI counseling so that they won’t be alarmed by the changes in how they feel, Dr. Assaad, chief of the division of endocrinology at Alexandria (Egypt) University, said in an interview.
Similarly, when a formerly euthyroid patient presents to an endocrinologist with sudden-onset hyperthyroidism, “Have you had a PCI recently?” should be one of the first questions asked. If the answer is yes, then further testing and imaging should be delayed at least 3 months, he noted.
Dr. Assaad and his associates examined 113 clinically euthyroid patients both before and several months after they underwent PCI for management of stable coronary artery disease. The cohort included 93 men, and patients’ ages ranged from 32 years to 73 years.
All the patients underwent a series of tests immediately before PCI, 24 hours after, and 3 months later. Those tests included serum free triiodothyronine (FT3), free thyroxine (FT4), thyroid-stimulating hormone (TSH), free T3/T4 ratio, antithyroperoxidase (anti-TPO), and high-sensitivity C-reactive protein.
The gland’s morphology, including volume, vascularity, nodules, and echogenicity, were assessed on the same timetable using ultrasonography.
One day after PCI, there was a significant increase in serum FT3 (5.2-0.5 vs. 3.3-0.7 pg/mL, P less than .001), and serum FT4 (1.3 – 0.5 vs 1.2 – 0.3 ng/dL, P = .04), with no significant change in serum TSH.
Three months after PCI, there was a further significant increase in serum FT4 (1.5 – 0.3 ng/dL), decrease in serum FT3 returning to baseline (3.2 – 1.3 pg/mL), and a significant increase in serum TSH, compared with just before PCI (mean, 3.2-5 vs. 1.5-2.1 mIU/L, P less than .001). Serum anti-TPO (AU/mL) showed a significant increase 3 months after PCI.
There was a significant increase in thyroid gland volume 3 months after PCI (13.6-3.9 vs. 13.1-3.5 cm3, P = .02). The measured echogenicity of the thyroid gland showed a significant decrease 3 months after PCI (67.1-10.9 vs. 88.7-25.6 GWE, P less than .001).
Thyroid radiation had a negative effect on serum TSH, anti-TPO, FT3, and FT3/FT4 ratio, and an inverse correlation of dye injection time with serum anti-TPO and TSH, judging from the findings of a regression analysis model.
Dr. Assaad was not included on the list of presenters with relevant financial disclosures that was provided by the American Thyroid Association.
DENVER – Undergoing percutaneous coronary intervention (PCI) may impair thyroid function and change the gland’s morphology, probably because of the cumulative effects of handling and exposure to radiation and iodine in the contrast dye, Samir Naim Assaad, MD, said during a poster presentation at the annual meeting of the American Thyroid Association.
Cardiologists should inform their patients of these possible effects as part of their pre- and post-PCI counseling so that they won’t be alarmed by the changes in how they feel, Dr. Assaad, chief of the division of endocrinology at Alexandria (Egypt) University, said in an interview.
Similarly, when a formerly euthyroid patient presents to an endocrinologist with sudden-onset hyperthyroidism, “Have you had a PCI recently?” should be one of the first questions asked. If the answer is yes, then further testing and imaging should be delayed at least 3 months, he noted.
Dr. Assaad and his associates examined 113 clinically euthyroid patients both before and several months after they underwent PCI for management of stable coronary artery disease. The cohort included 93 men, and patients’ ages ranged from 32 years to 73 years.
All the patients underwent a series of tests immediately before PCI, 24 hours after, and 3 months later. Those tests included serum free triiodothyronine (FT3), free thyroxine (FT4), thyroid-stimulating hormone (TSH), free T3/T4 ratio, antithyroperoxidase (anti-TPO), and high-sensitivity C-reactive protein.
The gland’s morphology, including volume, vascularity, nodules, and echogenicity, were assessed on the same timetable using ultrasonography.
One day after PCI, there was a significant increase in serum FT3 (5.2-0.5 vs. 3.3-0.7 pg/mL, P less than .001), and serum FT4 (1.3 – 0.5 vs 1.2 – 0.3 ng/dL, P = .04), with no significant change in serum TSH.
Three months after PCI, there was a further significant increase in serum FT4 (1.5 – 0.3 ng/dL), decrease in serum FT3 returning to baseline (3.2 – 1.3 pg/mL), and a significant increase in serum TSH, compared with just before PCI (mean, 3.2-5 vs. 1.5-2.1 mIU/L, P less than .001). Serum anti-TPO (AU/mL) showed a significant increase 3 months after PCI.
There was a significant increase in thyroid gland volume 3 months after PCI (13.6-3.9 vs. 13.1-3.5 cm3, P = .02). The measured echogenicity of the thyroid gland showed a significant decrease 3 months after PCI (67.1-10.9 vs. 88.7-25.6 GWE, P less than .001).
Thyroid radiation had a negative effect on serum TSH, anti-TPO, FT3, and FT3/FT4 ratio, and an inverse correlation of dye injection time with serum anti-TPO and TSH, judging from the findings of a regression analysis model.
Dr. Assaad was not included on the list of presenters with relevant financial disclosures that was provided by the American Thyroid Association.
DENVER – Undergoing percutaneous coronary intervention (PCI) may impair thyroid function and change the gland’s morphology, probably because of the cumulative effects of handling and exposure to radiation and iodine in the contrast dye, Samir Naim Assaad, MD, said during a poster presentation at the annual meeting of the American Thyroid Association.
Cardiologists should inform their patients of these possible effects as part of their pre- and post-PCI counseling so that they won’t be alarmed by the changes in how they feel, Dr. Assaad, chief of the division of endocrinology at Alexandria (Egypt) University, said in an interview.
Similarly, when a formerly euthyroid patient presents to an endocrinologist with sudden-onset hyperthyroidism, “Have you had a PCI recently?” should be one of the first questions asked. If the answer is yes, then further testing and imaging should be delayed at least 3 months, he noted.
Dr. Assaad and his associates examined 113 clinically euthyroid patients both before and several months after they underwent PCI for management of stable coronary artery disease. The cohort included 93 men, and patients’ ages ranged from 32 years to 73 years.
All the patients underwent a series of tests immediately before PCI, 24 hours after, and 3 months later. Those tests included serum free triiodothyronine (FT3), free thyroxine (FT4), thyroid-stimulating hormone (TSH), free T3/T4 ratio, antithyroperoxidase (anti-TPO), and high-sensitivity C-reactive protein.
The gland’s morphology, including volume, vascularity, nodules, and echogenicity, were assessed on the same timetable using ultrasonography.
One day after PCI, there was a significant increase in serum FT3 (5.2-0.5 vs. 3.3-0.7 pg/mL, P less than .001), and serum FT4 (1.3 – 0.5 vs 1.2 – 0.3 ng/dL, P = .04), with no significant change in serum TSH.
Three months after PCI, there was a further significant increase in serum FT4 (1.5 – 0.3 ng/dL), decrease in serum FT3 returning to baseline (3.2 – 1.3 pg/mL), and a significant increase in serum TSH, compared with just before PCI (mean, 3.2-5 vs. 1.5-2.1 mIU/L, P less than .001). Serum anti-TPO (AU/mL) showed a significant increase 3 months after PCI.
There was a significant increase in thyroid gland volume 3 months after PCI (13.6-3.9 vs. 13.1-3.5 cm3, P = .02). The measured echogenicity of the thyroid gland showed a significant decrease 3 months after PCI (67.1-10.9 vs. 88.7-25.6 GWE, P less than .001).
Thyroid radiation had a negative effect on serum TSH, anti-TPO, FT3, and FT3/FT4 ratio, and an inverse correlation of dye injection time with serum anti-TPO and TSH, judging from the findings of a regression analysis model.
Dr. Assaad was not included on the list of presenters with relevant financial disclosures that was provided by the American Thyroid Association.
AT THE ATA ANNUAL MEETING
Key clinical point: The thyroid function and morphology of any patient undergoing PCI may be altered by the procedure; but most changes normalize within several months.
Major finding: Thyroid function changes in close to 3% of patients undergoing PCI.
Data source: A study of 113 euthyroid patients who had PCI for coronary artery disease.
Disclosures: Dr. Assaad was not included on the list of presenters with relevant financial disclosures provided by the American Thyroid Association.
Lenvatinib sparked or worsened hypertension in patients with RAI-resistant thyroid cancer
DENVER – Patients put on lenvatinib for the management of radioactive iodine–resistant differentiated thyroid cancer need to be taught how to monitor their blood pressure, be given a cuff with which to do so, and be called daily by someone on the medical staff for at least the first 2 weeks, according to Sina A. Jasim, MD, reporting on real world use of the drug since its approval in February 2015.
For now, oncologists prescribe and manage this drug. But as lenvatinib (Lenvima, Eisai) becomes more widely used, endocrinologists can expect to be the ones prescribing it sometimes and counseling patients in the practical aspects of using this drug, Dr. Jasim of the Mayo Clinic, Rochester, Minn., said in an interview.
It was with endocrinologists in mind that Dr. Jasim and her associates compiled postapproval data on adverse events and patient quality of life. To date, no such data – including those from Mayo – have been published, she said during her presentation at the American Thyroid Association’s annual meeting.
While lenvatinib seems to be a promising therapeutic agent, adverse events are common with its use and occur early. Patients treated with it at Mayo get called by someone on the medical staff daily for the first 2 weeks of therapy, are given a blood pressure cuff, and are taught how to use it. They also receive the cell phone number of a member of the medical staff to consult with about sudden symptoms.
This retrospective analysis involved 25 sequentially treated patients given lenvatinib for RAI-resistant differentiated thyroid cancer (14 papillary, 7 poorly differentiated, 3 Hürthle cell, and 1 follicular). While all had received RAI, 11 also had received radiotherapy, 8 had been given at least one other kinase inhibitor previously, and 3 had received two. Fourteen were on an antihypertensive medication at baseline.
All patients initiated lenvatinib at the full dose, but it was reduced in four patients because of old age, renal impairment, or prior colitis. Twenty-one patients developed adverse events within the first month of being on the drug. Hypertension occurred in 16. Six of these required either a raising of the dose of antihypertensive drug they were on at baseline or initiation of antihypertensive therapy.
Adverse events were pronounced enough that the lenvatinib dose had to be lowered in 11 within a median 33 days of starting the drug. Drug treatment had to be interrupted for at least 3 weeks in four patients (two cases of cholecystitis, one case of diverticulitis, and one case of skin lesions).
Patients reported that their quality of life was stable at 2 months, but that their fatigue was worse.
The mean duration of lenvatinib therapy was 6.5 months. Twenty patients are alive at the time of this report.
The study was sponsored by the Mayo Clinic. Dr. Jasim reported that she had no relevant financial disclosures.
DENVER – Patients put on lenvatinib for the management of radioactive iodine–resistant differentiated thyroid cancer need to be taught how to monitor their blood pressure, be given a cuff with which to do so, and be called daily by someone on the medical staff for at least the first 2 weeks, according to Sina A. Jasim, MD, reporting on real world use of the drug since its approval in February 2015.
For now, oncologists prescribe and manage this drug. But as lenvatinib (Lenvima, Eisai) becomes more widely used, endocrinologists can expect to be the ones prescribing it sometimes and counseling patients in the practical aspects of using this drug, Dr. Jasim of the Mayo Clinic, Rochester, Minn., said in an interview.
It was with endocrinologists in mind that Dr. Jasim and her associates compiled postapproval data on adverse events and patient quality of life. To date, no such data – including those from Mayo – have been published, she said during her presentation at the American Thyroid Association’s annual meeting.
While lenvatinib seems to be a promising therapeutic agent, adverse events are common with its use and occur early. Patients treated with it at Mayo get called by someone on the medical staff daily for the first 2 weeks of therapy, are given a blood pressure cuff, and are taught how to use it. They also receive the cell phone number of a member of the medical staff to consult with about sudden symptoms.
This retrospective analysis involved 25 sequentially treated patients given lenvatinib for RAI-resistant differentiated thyroid cancer (14 papillary, 7 poorly differentiated, 3 Hürthle cell, and 1 follicular). While all had received RAI, 11 also had received radiotherapy, 8 had been given at least one other kinase inhibitor previously, and 3 had received two. Fourteen were on an antihypertensive medication at baseline.
All patients initiated lenvatinib at the full dose, but it was reduced in four patients because of old age, renal impairment, or prior colitis. Twenty-one patients developed adverse events within the first month of being on the drug. Hypertension occurred in 16. Six of these required either a raising of the dose of antihypertensive drug they were on at baseline or initiation of antihypertensive therapy.
Adverse events were pronounced enough that the lenvatinib dose had to be lowered in 11 within a median 33 days of starting the drug. Drug treatment had to be interrupted for at least 3 weeks in four patients (two cases of cholecystitis, one case of diverticulitis, and one case of skin lesions).
Patients reported that their quality of life was stable at 2 months, but that their fatigue was worse.
The mean duration of lenvatinib therapy was 6.5 months. Twenty patients are alive at the time of this report.
The study was sponsored by the Mayo Clinic. Dr. Jasim reported that she had no relevant financial disclosures.
DENVER – Patients put on lenvatinib for the management of radioactive iodine–resistant differentiated thyroid cancer need to be taught how to monitor their blood pressure, be given a cuff with which to do so, and be called daily by someone on the medical staff for at least the first 2 weeks, according to Sina A. Jasim, MD, reporting on real world use of the drug since its approval in February 2015.
For now, oncologists prescribe and manage this drug. But as lenvatinib (Lenvima, Eisai) becomes more widely used, endocrinologists can expect to be the ones prescribing it sometimes and counseling patients in the practical aspects of using this drug, Dr. Jasim of the Mayo Clinic, Rochester, Minn., said in an interview.
It was with endocrinologists in mind that Dr. Jasim and her associates compiled postapproval data on adverse events and patient quality of life. To date, no such data – including those from Mayo – have been published, she said during her presentation at the American Thyroid Association’s annual meeting.
While lenvatinib seems to be a promising therapeutic agent, adverse events are common with its use and occur early. Patients treated with it at Mayo get called by someone on the medical staff daily for the first 2 weeks of therapy, are given a blood pressure cuff, and are taught how to use it. They also receive the cell phone number of a member of the medical staff to consult with about sudden symptoms.
This retrospective analysis involved 25 sequentially treated patients given lenvatinib for RAI-resistant differentiated thyroid cancer (14 papillary, 7 poorly differentiated, 3 Hürthle cell, and 1 follicular). While all had received RAI, 11 also had received radiotherapy, 8 had been given at least one other kinase inhibitor previously, and 3 had received two. Fourteen were on an antihypertensive medication at baseline.
All patients initiated lenvatinib at the full dose, but it was reduced in four patients because of old age, renal impairment, or prior colitis. Twenty-one patients developed adverse events within the first month of being on the drug. Hypertension occurred in 16. Six of these required either a raising of the dose of antihypertensive drug they were on at baseline or initiation of antihypertensive therapy.
Adverse events were pronounced enough that the lenvatinib dose had to be lowered in 11 within a median 33 days of starting the drug. Drug treatment had to be interrupted for at least 3 weeks in four patients (two cases of cholecystitis, one case of diverticulitis, and one case of skin lesions).
Patients reported that their quality of life was stable at 2 months, but that their fatigue was worse.
The mean duration of lenvatinib therapy was 6.5 months. Twenty patients are alive at the time of this report.
The study was sponsored by the Mayo Clinic. Dr. Jasim reported that she had no relevant financial disclosures.
AT THE ATA ANNUAL MEETING
Key clinical point: Hypertension appeared suddenly or worsened abruptly in more than half of one group of patients with RAI-resistant differentiated thyroid cancer after initiation of treatment with lenvatinib.
Major finding: Of 25 patients in whom lenvatinib was initiated, 21 developed adverse events in the first month. Of those were 16 who developed hypertension, often requiring dose reduction.
Data source: A retrospective report on 25 consecutively treated patients with RAI-resistant differentiated thyroid cancer, who were given lenvatinib between February 2015 and May 2016.
Disclosures: The study was sponsored by the Mayo Clinic. Dr. Jasim reported that she had no relevant financial disclosures.
Few FPs comply with guidelines on acute external otitis management
Only a minority of family physicians comply with guidelines on the management of acute otitis externa in adults, whether they be residents working at a training clinic or more experienced clinicians in private practice, according to recent, unpublished research. Physicians are so hesitant to prescribe systemic antibiotics in this population that they leave patients without the medication they need, according to the investigators.
The most effective way to increase compliance may be to include relevant questions in the electronic health record, according to Dr. Sampath Medepalli, one of the investigators and a second-year resident in family practice at the Wichita Falls (Tex.) Family Practice Residency Program.
“Ultimately it is the physician’s responsibility to follow the guidelines, but by tweaking the EHR, we can ensure compliance,” he added, noting that the idea for this research stemmed from the American Board of Internal Medicine’s Choosing Wisely campaign.
The research found that physicians were twice as likely to fail to prescribe systemic antibiotics when warranted than they were to prescribe systemic antibiotics when unwarranted.
The investigators assessed whether management of 236 patients presenting with suspected acute otitis externa (AOE) was carried out according to guidelines issued by the American Academy of Otolaryngology-Head and Neck Surgery Foundation. The guidelines were issued first in 2006 and updated in 2014 (Otolaryngol Head Neck Surg. 2014 Feb;150[1] suppl. S1-S24. doi: 10.1177/0194599813517083, Dr. Medepalli said in an interview. The guidelines advise against prescribing oral antibiotics to adults unless they have complicated AOE, such as a ruptured tympanic membrane or have compromised immunity, due to diabetes, pharmacological immune suppression, or other factors.
The study was designed to assess whether family physicians prescribed antibiotics and analgesic appropriately and provided substantial patient education. Chart reviews of 236 adults diagnosed with AOE between 2009 and 2015 were included; the investigators excluded anyone with complicated AOE.
Of the patients treated in the private practice family medicine practice, topical antibiotics only were given to 106 patients with noncompromised immune systems, which was consistent with the guidelines. Eight patients without a compromised immune system were given systemic antibiotics, for a 62% compliance rate. In comparison, topical antibiotics were given to 11 patients with compromised immunity, and only 3 received systemic antibiotics (44% compliance with the guidelines).
Of patients treated by residents at the residency run training clinic, only 3 of 19 patients received unnecessary systemic antibiotics, for 64% compliance. The other 16 were treated with topical agents. Of the five patients with compromised immunity, only two received the systemic antibiotics for which they were candidates, for a 50% compliance.
Looking at all patients regardless of whether they received care from the training clinic or private practice, compliance with the guidelines was achieved for 62% of those with noncompromised immunity and 46% of those with immunity shortcomings. Overall 15.42% of family physicians treated patients in accordance with the AOE guidelines.
The investigators also assessed physicians’ pain management and found that only 29% of patients treated at the residency-run outpatient clinic and 13% of those treated in private practice received either topical or systemic medication to lessen the pain associated with their AOE.
The guidelines call for physicians to educate their patients about water precautions, use of prophylactic drops, and addressing their immune compromise among other topics related to AOE. In most cases neither the residents nor the private practitioners documented that they provided such counseling.
The average age of patients cared for at the residency clinic was 43.86 years while those who received care from the privater practice averaged 21.3 years of age, a significant difference (P less than .001). There were significantly fewer minority patients in the private practice clinic than the resident clinic (2% vs. 19%; P less than .001),
This research won the Doctor’s Choice award at the 2015 meeting of the Texas Medical Association Congress in Austin. The Wichita Falls Family Practice Residency Program funded the study. Dr. Medepalli and his associates had no relevant financial conflicts of interest to declare.
Only a minority of family physicians comply with guidelines on the management of acute otitis externa in adults, whether they be residents working at a training clinic or more experienced clinicians in private practice, according to recent, unpublished research. Physicians are so hesitant to prescribe systemic antibiotics in this population that they leave patients without the medication they need, according to the investigators.
The most effective way to increase compliance may be to include relevant questions in the electronic health record, according to Dr. Sampath Medepalli, one of the investigators and a second-year resident in family practice at the Wichita Falls (Tex.) Family Practice Residency Program.
“Ultimately it is the physician’s responsibility to follow the guidelines, but by tweaking the EHR, we can ensure compliance,” he added, noting that the idea for this research stemmed from the American Board of Internal Medicine’s Choosing Wisely campaign.
The research found that physicians were twice as likely to fail to prescribe systemic antibiotics when warranted than they were to prescribe systemic antibiotics when unwarranted.
The investigators assessed whether management of 236 patients presenting with suspected acute otitis externa (AOE) was carried out according to guidelines issued by the American Academy of Otolaryngology-Head and Neck Surgery Foundation. The guidelines were issued first in 2006 and updated in 2014 (Otolaryngol Head Neck Surg. 2014 Feb;150[1] suppl. S1-S24. doi: 10.1177/0194599813517083, Dr. Medepalli said in an interview. The guidelines advise against prescribing oral antibiotics to adults unless they have complicated AOE, such as a ruptured tympanic membrane or have compromised immunity, due to diabetes, pharmacological immune suppression, or other factors.
The study was designed to assess whether family physicians prescribed antibiotics and analgesic appropriately and provided substantial patient education. Chart reviews of 236 adults diagnosed with AOE between 2009 and 2015 were included; the investigators excluded anyone with complicated AOE.
Of the patients treated in the private practice family medicine practice, topical antibiotics only were given to 106 patients with noncompromised immune systems, which was consistent with the guidelines. Eight patients without a compromised immune system were given systemic antibiotics, for a 62% compliance rate. In comparison, topical antibiotics were given to 11 patients with compromised immunity, and only 3 received systemic antibiotics (44% compliance with the guidelines).
Of patients treated by residents at the residency run training clinic, only 3 of 19 patients received unnecessary systemic antibiotics, for 64% compliance. The other 16 were treated with topical agents. Of the five patients with compromised immunity, only two received the systemic antibiotics for which they were candidates, for a 50% compliance.
Looking at all patients regardless of whether they received care from the training clinic or private practice, compliance with the guidelines was achieved for 62% of those with noncompromised immunity and 46% of those with immunity shortcomings. Overall 15.42% of family physicians treated patients in accordance with the AOE guidelines.
The investigators also assessed physicians’ pain management and found that only 29% of patients treated at the residency-run outpatient clinic and 13% of those treated in private practice received either topical or systemic medication to lessen the pain associated with their AOE.
The guidelines call for physicians to educate their patients about water precautions, use of prophylactic drops, and addressing their immune compromise among other topics related to AOE. In most cases neither the residents nor the private practitioners documented that they provided such counseling.
The average age of patients cared for at the residency clinic was 43.86 years while those who received care from the privater practice averaged 21.3 years of age, a significant difference (P less than .001). There were significantly fewer minority patients in the private practice clinic than the resident clinic (2% vs. 19%; P less than .001),
This research won the Doctor’s Choice award at the 2015 meeting of the Texas Medical Association Congress in Austin. The Wichita Falls Family Practice Residency Program funded the study. Dr. Medepalli and his associates had no relevant financial conflicts of interest to declare.
Only a minority of family physicians comply with guidelines on the management of acute otitis externa in adults, whether they be residents working at a training clinic or more experienced clinicians in private practice, according to recent, unpublished research. Physicians are so hesitant to prescribe systemic antibiotics in this population that they leave patients without the medication they need, according to the investigators.
The most effective way to increase compliance may be to include relevant questions in the electronic health record, according to Dr. Sampath Medepalli, one of the investigators and a second-year resident in family practice at the Wichita Falls (Tex.) Family Practice Residency Program.
“Ultimately it is the physician’s responsibility to follow the guidelines, but by tweaking the EHR, we can ensure compliance,” he added, noting that the idea for this research stemmed from the American Board of Internal Medicine’s Choosing Wisely campaign.
The research found that physicians were twice as likely to fail to prescribe systemic antibiotics when warranted than they were to prescribe systemic antibiotics when unwarranted.
The investigators assessed whether management of 236 patients presenting with suspected acute otitis externa (AOE) was carried out according to guidelines issued by the American Academy of Otolaryngology-Head and Neck Surgery Foundation. The guidelines were issued first in 2006 and updated in 2014 (Otolaryngol Head Neck Surg. 2014 Feb;150[1] suppl. S1-S24. doi: 10.1177/0194599813517083, Dr. Medepalli said in an interview. The guidelines advise against prescribing oral antibiotics to adults unless they have complicated AOE, such as a ruptured tympanic membrane or have compromised immunity, due to diabetes, pharmacological immune suppression, or other factors.
The study was designed to assess whether family physicians prescribed antibiotics and analgesic appropriately and provided substantial patient education. Chart reviews of 236 adults diagnosed with AOE between 2009 and 2015 were included; the investigators excluded anyone with complicated AOE.
Of the patients treated in the private practice family medicine practice, topical antibiotics only were given to 106 patients with noncompromised immune systems, which was consistent with the guidelines. Eight patients without a compromised immune system were given systemic antibiotics, for a 62% compliance rate. In comparison, topical antibiotics were given to 11 patients with compromised immunity, and only 3 received systemic antibiotics (44% compliance with the guidelines).
Of patients treated by residents at the residency run training clinic, only 3 of 19 patients received unnecessary systemic antibiotics, for 64% compliance. The other 16 were treated with topical agents. Of the five patients with compromised immunity, only two received the systemic antibiotics for which they were candidates, for a 50% compliance.
Looking at all patients regardless of whether they received care from the training clinic or private practice, compliance with the guidelines was achieved for 62% of those with noncompromised immunity and 46% of those with immunity shortcomings. Overall 15.42% of family physicians treated patients in accordance with the AOE guidelines.
The investigators also assessed physicians’ pain management and found that only 29% of patients treated at the residency-run outpatient clinic and 13% of those treated in private practice received either topical or systemic medication to lessen the pain associated with their AOE.
The guidelines call for physicians to educate their patients about water precautions, use of prophylactic drops, and addressing their immune compromise among other topics related to AOE. In most cases neither the residents nor the private practitioners documented that they provided such counseling.
The average age of patients cared for at the residency clinic was 43.86 years while those who received care from the privater practice averaged 21.3 years of age, a significant difference (P less than .001). There were significantly fewer minority patients in the private practice clinic than the resident clinic (2% vs. 19%; P less than .001),
This research won the Doctor’s Choice award at the 2015 meeting of the Texas Medical Association Congress in Austin. The Wichita Falls Family Practice Residency Program funded the study. Dr. Medepalli and his associates had no relevant financial conflicts of interest to declare.
Key clinical point: Family physicians are underprescribing antibiotics to adults with uncomplicated AOE who are candidates for systemic treatment.
Major finding: Only 15.42% of FPs abided by the recommendations of the guidelines on the management of AOE.
Data source: Review of the charts of patients from two family practice outpatient clinics.
Disclosures: The Wichita Falls Family Practice Residency Program funded the study. Dr. Medepalli and his associates had no relevant financial conflicts of interest to declare.