Type 2 Diabetes ICYMI

Dehydrated human umbilical cord allograft may have benefit over alginate wound dressings as a treatment for chronic, nonhealing diabetic foot ulcers (DFU), findings from an industry-funded, randomized controlled study suggest.

The findings “provide additional evidence of the safety and efficacy of dehydrated placental tissues,” wrote William Tettelbach, MD, and his colleagues. Their report is in International Wound Journal.

The burden of diabetic foot disease in the United States is immense. A 2014 study estimated that treatment of DFUs alone cost public and private insurers as much as $13 billion per year (Diabetes Care. 2014;37(3):651-8).

MiMedx, which funded the new study, has developed a product called EpiCord to protect the DFU wound site. The product’s website describes it as a “unique, thick membrane derived from umbilical cord” that’s “minimally manipulated, dehydrated, [and] non-viable” (www.mimedx.com/epicord). The study authors noted that “immunogenicity of placental tissue lends credence to its use as an allograft material for difficult-to-heal wounds.”

For the new study, which was conducted from 2016 to 2018 and led by Dr. Tettelbach, an infectious disease specialist who is now an employee of MiMedx, the researchers enlisted 155 adult patients with stubborn DFUs at 11 centers in the United States.

All the ulcers had 30% or less wound area reduction after 14 days of standard care. The majority of patients (81%) were male; 63% were obese, 43% were smokers, and 17% had a prior amputation.

The patients were randomly assigned to receive a weekly application of EpiCord (n = 101) or treatment with an alginate wound dressing (n = 54) in addition to standard care. The percentage of patients whose wounds healed completely by 12 weeks later was higher in the study group than in those who were treated with alginate dressings (70% vs. 48%, respectively; P = .0089), per an intent-to-treat analysis.

The researchers also focused purely on patients who had received adequate debridement (107/155 ulcers, 69%). Of those ulcers, 64/67 (96%), in the study group healed completely at 12 weeks, compared with 26/40 (65%) of the alginate group (P less than .0001.)

The researchers did not notice any adverse effects related to either dressing.

According to the study, the findings regarding EpiCord are comparable with a sister study of a similar product by the same company that was tested in diabetic lower-extremity ulcers. That study, of a product called EpiFix, was published in the same issue of the journal (Int Wound J. 2019 Feb;16[1]:19-29).

“A thicker and more durable allograft such as EpiCord may be a good choice for implantation into deeper wounds and in situations where suturing the allograft in place is desired,” the authors wrote of the EpiCord study.

MiMedx provided research funding to all of the authors.

SOURCE: Tettelbach W et al. Int Wound J. 2019;16(1):122-130. doi: 10.1111/iwj.12976.

Dehydrated human umbilical cord allograft may have benefit over alginate wound dressings as a treatment for chronic, nonhealing diabetic foot ulcers (DFU), findings from an industry-funded, randomized controlled study suggest.

The findings “provide additional evidence of the safety and efficacy of dehydrated placental tissues,” wrote William Tettelbach, MD, and his colleagues. Their report is in International Wound Journal.

The burden of diabetic foot disease in the United States is immense. A 2014 study estimated that treatment of DFUs alone cost public and private insurers as much as $13 billion per year (Diabetes Care. 2014;37(3):651-8).

MiMedx, which funded the new study, has developed a product called EpiCord to protect the DFU wound site. The product’s website describes it as a “unique, thick membrane derived from umbilical cord” that’s “minimally manipulated, dehydrated, [and] non-viable” (www.mimedx.com/epicord). The study authors noted that “immunogenicity of placental tissue lends credence to its use as an allograft material for difficult-to-heal wounds.”

For the new study, which was conducted from 2016 to 2018 and led by Dr. Tettelbach, an infectious disease specialist who is now an employee of MiMedx, the researchers enlisted 155 adult patients with stubborn DFUs at 11 centers in the United States.

All the ulcers had 30% or less wound area reduction after 14 days of standard care. The majority of patients (81%) were male; 63% were obese, 43% were smokers, and 17% had a prior amputation.

The patients were randomly assigned to receive a weekly application of EpiCord (n = 101) or treatment with an alginate wound dressing (n = 54) in addition to standard care. The percentage of patients whose wounds healed completely by 12 weeks later was higher in the study group than in those who were treated with alginate dressings (70% vs. 48%, respectively; P = .0089), per an intent-to-treat analysis.

The researchers also focused purely on patients who had received adequate debridement (107/155 ulcers, 69%). Of those ulcers, 64/67 (96%), in the study group healed completely at 12 weeks, compared with 26/40 (65%) of the alginate group (P less than .0001.)

The researchers did not notice any adverse effects related to either dressing.

According to the study, the findings regarding EpiCord are comparable with a sister study of a similar product by the same company that was tested in diabetic lower-extremity ulcers. That study, of a product called EpiFix, was published in the same issue of the journal (Int Wound J. 2019 Feb;16[1]:19-29).

“A thicker and more durable allograft such as EpiCord may be a good choice for implantation into deeper wounds and in situations where suturing the allograft in place is desired,” the authors wrote of the EpiCord study.

MiMedx provided research funding to all of the authors.

SOURCE: Tettelbach W et al. Int Wound J. 2019;16(1):122-130. doi: 10.1111/iwj.12976.

Dehydrated human umbilical cord allograft may have benefit over alginate wound dressings as a treatment for chronic, nonhealing diabetic foot ulcers (DFU), findings from an industry-funded, randomized controlled study suggest.

The findings “provide additional evidence of the safety and efficacy of dehydrated placental tissues,” wrote William Tettelbach, MD, and his colleagues. Their report is in International Wound Journal.

The burden of diabetic foot disease in the United States is immense. A 2014 study estimated that treatment of DFUs alone cost public and private insurers as much as $13 billion per year (Diabetes Care. 2014;37(3):651-8).

MiMedx, which funded the new study, has developed a product called EpiCord to protect the DFU wound site. The product’s website describes it as a “unique, thick membrane derived from umbilical cord” that’s “minimally manipulated, dehydrated, [and] non-viable” (www.mimedx.com/epicord). The study authors noted that “immunogenicity of placental tissue lends credence to its use as an allograft material for difficult-to-heal wounds.”

For the new study, which was conducted from 2016 to 2018 and led by Dr. Tettelbach, an infectious disease specialist who is now an employee of MiMedx, the researchers enlisted 155 adult patients with stubborn DFUs at 11 centers in the United States.

All the ulcers had 30% or less wound area reduction after 14 days of standard care. The majority of patients (81%) were male; 63% were obese, 43% were smokers, and 17% had a prior amputation.

The patients were randomly assigned to receive a weekly application of EpiCord (n = 101) or treatment with an alginate wound dressing (n = 54) in addition to standard care. The percentage of patients whose wounds healed completely by 12 weeks later was higher in the study group than in those who were treated with alginate dressings (70% vs. 48%, respectively; P = .0089), per an intent-to-treat analysis.

The researchers also focused purely on patients who had received adequate debridement (107/155 ulcers, 69%). Of those ulcers, 64/67 (96%), in the study group healed completely at 12 weeks, compared with 26/40 (65%) of the alginate group (P less than .0001.)

The researchers did not notice any adverse effects related to either dressing.

According to the study, the findings regarding EpiCord are comparable with a sister study of a similar product by the same company that was tested in diabetic lower-extremity ulcers. That study, of a product called EpiFix, was published in the same issue of the journal (Int Wound J. 2019 Feb;16[1]:19-29).

“A thicker and more durable allograft such as EpiCord may be a good choice for implantation into deeper wounds and in situations where suturing the allograft in place is desired,” the authors wrote of the EpiCord study.

MiMedx provided research funding to all of the authors.

SOURCE: Tettelbach W et al. Int Wound J. 2019;16(1):122-130. doi: 10.1111/iwj.12976.

A behavioral intervention that involves regular counseling sessions could help patients with type 2 diabetes increase their levels of physical activity and decrease their amount of sedentary time, according to findings from a prospective, randomized trial of 300 physically inactive patients with type 2 diabetes.

“The primary strength of this study is the application of an intervention targeting both physical activity and sedentary time across all settings (e.g., leisure, transportation, household, and occupation), based on theoretical grounds and using several behavior-change techniques,” wrote Stefano Balducci, MD, of Sapienza University in Rome and his colleagues. The findings were published in JAMA.

Half the participants were randomized to an intervention that involved one individual theoretical counseling session with a diabetologist and eight biweekly theoretical and practical counseling sessions with an exercise specialist each year for 3 years. The other half received standard care in the form of recommendations from their general physician about increasing physical activity and decreasing sedentary time. Both groups also received the same general treatment regimen according to guidelines.

The findings showed significant increases in volume of physical activity, light-intensity physical activity, and moderate to vigorous physical activity in the intervention group during the first 4 months of the trial. Those increases also were greater than the increases seen in the usual care group. Patients in the intervention group also showed greater decreases in sedentary time, compared with those in the control group during the same time.

After 4 months, the increases in physical activity in the intervention group plateaued but remained stable until 2 years. After that, the levels of activity declined but still remained significantly higher than at baseline. The level of sedentary time also increased after 2 years but was still lower than at baseline.

By the end of the study, the intervention group accumulated 13.8 metabolic equivalent hours/week of physical activity volume, compared with 10.5 hours in the control group; 18.9 minutes/day of moderate to vigorous intensity physical activity, compared with 12.5 minutes in the control group; and 4.6 hours/day of light-intensity physical activity, compared with 3.8 hours in the control group. In regard to sedentary time, the intervention group accumulated 10.9 hours/day, compared with 11.7 hours in the control group. All differences were statistically significant.

“The present findings support the need for interventions targeting all domains of behavior to obtain substantial lifestyle changes, not limited to moderate- to vigorous-intensity physical activity, which has little effect on sedentary time,” Dr. Balducci and his coauthors wrote. “This concept is consistent with a 2018 report showing that physical activity, sedentary time, and cardiorespiratory fitness are all important for cardiometabolic health.”

For the secondary outcomes of cardiorespiratory fitness and lower-body strength, the authors saw significant improvements in the intervention group, whereas the control group showed a worsening in those outcomes. The intervention group also showed significant improvements in fasting plasma glucose level, systolic blood pressure, total coronary heart disease 10-year risk score, and fatal coronary heart disease 10-year risk score. They also had significantly greater improvements than did the control group in total stroke risk score, hemoglobin A_1c, fasting plasma glucose levels, and coronary heart disease risk.

In all, there were 41 adverse events in the intervention group, compared with 59 in the control group, outside of the sessions. During the sessions, participants in the intervention group experienced mild hypoglycemia (8 episodes), tachycardia/arrhythmia (3), and musculoskeletal injury or discomfort (19).

One of the limitations highlighted by the authors was that the benefits of their strategy could vary in other cohorts because of differences in climatic, socioeconomic, or cultural settings.

The study was supported by the Metabolic Fitness Association. Three authors declared grants and personal fees from pharmaceutical companies, and one author was an employee of Technogym. No other conflicts of interest were declared.

SOURCE: Balducci S et al. JAMA. 2019;321:880-90.
 

A behavioral intervention that involves regular counseling sessions could help patients with type 2 diabetes increase their levels of physical activity and decrease their amount of sedentary time, according to findings from a prospective, randomized trial of 300 physically inactive patients with type 2 diabetes.

“The primary strength of this study is the application of an intervention targeting both physical activity and sedentary time across all settings (e.g., leisure, transportation, household, and occupation), based on theoretical grounds and using several behavior-change techniques,” wrote Stefano Balducci, MD, of Sapienza University in Rome and his colleagues. The findings were published in JAMA.

Half the participants were randomized to an intervention that involved one individual theoretical counseling session with a diabetologist and eight biweekly theoretical and practical counseling sessions with an exercise specialist each year for 3 years. The other half received standard care in the form of recommendations from their general physician about increasing physical activity and decreasing sedentary time. Both groups also received the same general treatment regimen according to guidelines.

The findings showed significant increases in volume of physical activity, light-intensity physical activity, and moderate to vigorous physical activity in the intervention group during the first 4 months of the trial. Those increases also were greater than the increases seen in the usual care group. Patients in the intervention group also showed greater decreases in sedentary time, compared with those in the control group during the same time.

After 4 months, the increases in physical activity in the intervention group plateaued but remained stable until 2 years. After that, the levels of activity declined but still remained significantly higher than at baseline. The level of sedentary time also increased after 2 years but was still lower than at baseline.

By the end of the study, the intervention group accumulated 13.8 metabolic equivalent hours/week of physical activity volume, compared with 10.5 hours in the control group; 18.9 minutes/day of moderate to vigorous intensity physical activity, compared with 12.5 minutes in the control group; and 4.6 hours/day of light-intensity physical activity, compared with 3.8 hours in the control group. In regard to sedentary time, the intervention group accumulated 10.9 hours/day, compared with 11.7 hours in the control group. All differences were statistically significant.

“The present findings support the need for interventions targeting all domains of behavior to obtain substantial lifestyle changes, not limited to moderate- to vigorous-intensity physical activity, which has little effect on sedentary time,” Dr. Balducci and his coauthors wrote. “This concept is consistent with a 2018 report showing that physical activity, sedentary time, and cardiorespiratory fitness are all important for cardiometabolic health.”

For the secondary outcomes of cardiorespiratory fitness and lower-body strength, the authors saw significant improvements in the intervention group, whereas the control group showed a worsening in those outcomes. The intervention group also showed significant improvements in fasting plasma glucose level, systolic blood pressure, total coronary heart disease 10-year risk score, and fatal coronary heart disease 10-year risk score. They also had significantly greater improvements than did the control group in total stroke risk score, hemoglobin A_1c, fasting plasma glucose levels, and coronary heart disease risk.

In all, there were 41 adverse events in the intervention group, compared with 59 in the control group, outside of the sessions. During the sessions, participants in the intervention group experienced mild hypoglycemia (8 episodes), tachycardia/arrhythmia (3), and musculoskeletal injury or discomfort (19).

One of the limitations highlighted by the authors was that the benefits of their strategy could vary in other cohorts because of differences in climatic, socioeconomic, or cultural settings.

The study was supported by the Metabolic Fitness Association. Three authors declared grants and personal fees from pharmaceutical companies, and one author was an employee of Technogym. No other conflicts of interest were declared.

SOURCE: Balducci S et al. JAMA. 2019;321:880-90.
 

A behavioral intervention that involves regular counseling sessions could help patients with type 2 diabetes increase their levels of physical activity and decrease their amount of sedentary time, according to findings from a prospective, randomized trial of 300 physically inactive patients with type 2 diabetes.

“The primary strength of this study is the application of an intervention targeting both physical activity and sedentary time across all settings (e.g., leisure, transportation, household, and occupation), based on theoretical grounds and using several behavior-change techniques,” wrote Stefano Balducci, MD, of Sapienza University in Rome and his colleagues. The findings were published in JAMA.

Half the participants were randomized to an intervention that involved one individual theoretical counseling session with a diabetologist and eight biweekly theoretical and practical counseling sessions with an exercise specialist each year for 3 years. The other half received standard care in the form of recommendations from their general physician about increasing physical activity and decreasing sedentary time. Both groups also received the same general treatment regimen according to guidelines.

The findings showed significant increases in volume of physical activity, light-intensity physical activity, and moderate to vigorous physical activity in the intervention group during the first 4 months of the trial. Those increases also were greater than the increases seen in the usual care group. Patients in the intervention group also showed greater decreases in sedentary time, compared with those in the control group during the same time.

After 4 months, the increases in physical activity in the intervention group plateaued but remained stable until 2 years. After that, the levels of activity declined but still remained significantly higher than at baseline. The level of sedentary time also increased after 2 years but was still lower than at baseline.

By the end of the study, the intervention group accumulated 13.8 metabolic equivalent hours/week of physical activity volume, compared with 10.5 hours in the control group; 18.9 minutes/day of moderate to vigorous intensity physical activity, compared with 12.5 minutes in the control group; and 4.6 hours/day of light-intensity physical activity, compared with 3.8 hours in the control group. In regard to sedentary time, the intervention group accumulated 10.9 hours/day, compared with 11.7 hours in the control group. All differences were statistically significant.

“The present findings support the need for interventions targeting all domains of behavior to obtain substantial lifestyle changes, not limited to moderate- to vigorous-intensity physical activity, which has little effect on sedentary time,” Dr. Balducci and his coauthors wrote. “This concept is consistent with a 2018 report showing that physical activity, sedentary time, and cardiorespiratory fitness are all important for cardiometabolic health.”

For the secondary outcomes of cardiorespiratory fitness and lower-body strength, the authors saw significant improvements in the intervention group, whereas the control group showed a worsening in those outcomes. The intervention group also showed significant improvements in fasting plasma glucose level, systolic blood pressure, total coronary heart disease 10-year risk score, and fatal coronary heart disease 10-year risk score. They also had significantly greater improvements than did the control group in total stroke risk score, hemoglobin A_1c, fasting plasma glucose levels, and coronary heart disease risk.

In all, there were 41 adverse events in the intervention group, compared with 59 in the control group, outside of the sessions. During the sessions, participants in the intervention group experienced mild hypoglycemia (8 episodes), tachycardia/arrhythmia (3), and musculoskeletal injury or discomfort (19).

One of the limitations highlighted by the authors was that the benefits of their strategy could vary in other cohorts because of differences in climatic, socioeconomic, or cultural settings.

The study was supported by the Metabolic Fitness Association. Three authors declared grants and personal fees from pharmaceutical companies, and one author was an employee of Technogym. No other conflicts of interest were declared.

SOURCE: Balducci S et al. JAMA. 2019;321:880-90.
 

WASHINGTON – The American Contact Dermatitis Society has selected isobornyl acrylate the contact allergen of the year. It is an acrylic monomer used as an adhesive.

Vidyard Video

Among other applications, isobornyl acrylate is often used in medical devices. The selection was made based in part on multiple case reports of diabetes patients developing contact allergies to their diabetes devices, such as insulin pumps, explained Golara Honari, MD, of Stanford (Calif.) University, who presented the selection at the ACDS annual meeting.

The significance of this allergen is that testing through routine panels does not identify it, so clinician awareness is especially important, Dr. Honari noted in a video interview at the meeting.

Most of the reported contact allergen cases have been in patients with diabetes, but clinicians should think about other possible sources, such as acrylic nails, she said. As for treatment, clinicians and patients can consider alternative diabetes devices without isobornyl acrylate, she said.

In the future, close collaboration between clinicians and the medical device industry to develop appropriate labeling can help increase awareness of the potential for allergic reactions, she added.

Dr. Honari had no relevant financial conflicts to disclose.

WASHINGTON – The American Contact Dermatitis Society has selected isobornyl acrylate the contact allergen of the year. It is an acrylic monomer used as an adhesive.

Vidyard Video

Among other applications, isobornyl acrylate is often used in medical devices. The selection was made based in part on multiple case reports of diabetes patients developing contact allergies to their diabetes devices, such as insulin pumps, explained Golara Honari, MD, of Stanford (Calif.) University, who presented the selection at the ACDS annual meeting.

The significance of this allergen is that testing through routine panels does not identify it, so clinician awareness is especially important, Dr. Honari noted in a video interview at the meeting.

Most of the reported contact allergen cases have been in patients with diabetes, but clinicians should think about other possible sources, such as acrylic nails, she said. As for treatment, clinicians and patients can consider alternative diabetes devices without isobornyl acrylate, she said.

In the future, close collaboration between clinicians and the medical device industry to develop appropriate labeling can help increase awareness of the potential for allergic reactions, she added.

Dr. Honari had no relevant financial conflicts to disclose.

WASHINGTON – The American Contact Dermatitis Society has selected isobornyl acrylate the contact allergen of the year. It is an acrylic monomer used as an adhesive.

Vidyard Video

Among other applications, isobornyl acrylate is often used in medical devices. The selection was made based in part on multiple case reports of diabetes patients developing contact allergies to their diabetes devices, such as insulin pumps, explained Golara Honari, MD, of Stanford (Calif.) University, who presented the selection at the ACDS annual meeting.

The significance of this allergen is that testing through routine panels does not identify it, so clinician awareness is especially important, Dr. Honari noted in a video interview at the meeting.

Most of the reported contact allergen cases have been in patients with diabetes, but clinicians should think about other possible sources, such as acrylic nails, she said. As for treatment, clinicians and patients can consider alternative diabetes devices without isobornyl acrylate, she said.

In the future, close collaboration between clinicians and the medical device industry to develop appropriate labeling can help increase awareness of the potential for allergic reactions, she added.

Dr. Honari had no relevant financial conflicts to disclose.

Here are 5 articles from the March issue of Clinician Reviews (individual articles are valid for one year from date of publication—expiration dates below):

1. Endometriosis surgery: Women can expect years-long benefits

To take the posttest, go to: https://bit.ly/2Ez8mdu
Expires January 3, 2019

2. Cerebral small vessel disease progression linked to MCI in hypertensive patients

To take the posttest, go to: https://bit.ly/2ExDV7o
Expires January 4, 2019

3. Adult atopic dermatitis is fraught with dermatologic comorbidities

To take the posttest, go to: https://bit.ly/2Vl7E9a
Expires January 11, 2019

4. Antidepressants tied to greater hip fracture incidence in older adults

To take the posttest, go to: https://bit.ly/2GRfMeH
Expires January 4, 2019

5. Researchers exploring ways to mitigate aging’s impact on diabetes

To take the posttest, go to: https://bit.ly/2tFxF7v
Expires January 8, 2019

Here are 5 articles from the March issue of Clinician Reviews (individual articles are valid for one year from date of publication—expiration dates below):

1. Endometriosis surgery: Women can expect years-long benefits

To take the posttest, go to: https://bit.ly/2Ez8mdu
Expires January 3, 2019

2. Cerebral small vessel disease progression linked to MCI in hypertensive patients

To take the posttest, go to: https://bit.ly/2ExDV7o
Expires January 4, 2019

3. Adult atopic dermatitis is fraught with dermatologic comorbidities

To take the posttest, go to: https://bit.ly/2Vl7E9a
Expires January 11, 2019

4. Antidepressants tied to greater hip fracture incidence in older adults

To take the posttest, go to: https://bit.ly/2GRfMeH
Expires January 4, 2019

5. Researchers exploring ways to mitigate aging’s impact on diabetes

To take the posttest, go to: https://bit.ly/2tFxF7v
Expires January 8, 2019

Here are 5 articles from the March issue of Clinician Reviews (individual articles are valid for one year from date of publication—expiration dates below):

1. Endometriosis surgery: Women can expect years-long benefits

To take the posttest, go to: https://bit.ly/2Ez8mdu
Expires January 3, 2019

2. Cerebral small vessel disease progression linked to MCI in hypertensive patients

To take the posttest, go to: https://bit.ly/2ExDV7o
Expires January 4, 2019

3. Adult atopic dermatitis is fraught with dermatologic comorbidities

To take the posttest, go to: https://bit.ly/2Vl7E9a
Expires January 11, 2019

4. Antidepressants tied to greater hip fracture incidence in older adults

To take the posttest, go to: https://bit.ly/2GRfMeH
Expires January 4, 2019

5. Researchers exploring ways to mitigate aging’s impact on diabetes

To take the posttest, go to: https://bit.ly/2tFxF7v
Expires January 8, 2019

The Food and Drug Administration has approved a label extension for Farxiga (dapagliflozin) and Xigduo XR (extended-release dapagliflozin and metformin HCl) for use in patients with type 2 diabetes and moderate renal impairment, lowering the estimated glomerular filtration rate (eGFR) threshold to 45 mL/min per 1.73 m² from the current60 mL/min per 1.73 m².

The update is based on results from DERIVE, a phase 3 study in patients with inadequately controlled diabetes and an eGFR of 45-59 mL/min per 1.73 m² who received either dapagliflozin 10 mg or placebo during a 24-week period. After that time, patients who received dapagliflozin had significant reductions in glycosylated hemoglobin, compared with placebo. The safety profile was similar to that in other studies with dapagliflozin.

The most common adverse events associated with Farxiga are female genital mycotic infections, nasopharyngitis, and urinary tract infections. For Xigduo XR, the most common adverse events are female genital mycotic infection, nasopharyngitis, urinary tract infection, diarrhea, and headache.

“The DERIVE study, which further confirmed the well-established efficacy and safety profile for Farxiga and Xigduo XR, has resulted in important label changes for patients with type 2 diabetes that enable a broader population with impaired renal function to potentially benefit from these important treatment options,” Jim McDermott, PhD, vice president, U.S. medical affairs, diabetes, at AstraZeneca, said in the press release.

Find the full press release on the AstraZeneca website.

[email protected]

The Food and Drug Administration has approved a label extension for Farxiga (dapagliflozin) and Xigduo XR (extended-release dapagliflozin and metformin HCl) for use in patients with type 2 diabetes and moderate renal impairment, lowering the estimated glomerular filtration rate (eGFR) threshold to 45 mL/min per 1.73 m² from the current60 mL/min per 1.73 m².

The update is based on results from DERIVE, a phase 3 study in patients with inadequately controlled diabetes and an eGFR of 45-59 mL/min per 1.73 m² who received either dapagliflozin 10 mg or placebo during a 24-week period. After that time, patients who received dapagliflozin had significant reductions in glycosylated hemoglobin, compared with placebo. The safety profile was similar to that in other studies with dapagliflozin.

The most common adverse events associated with Farxiga are female genital mycotic infections, nasopharyngitis, and urinary tract infections. For Xigduo XR, the most common adverse events are female genital mycotic infection, nasopharyngitis, urinary tract infection, diarrhea, and headache.

“The DERIVE study, which further confirmed the well-established efficacy and safety profile for Farxiga and Xigduo XR, has resulted in important label changes for patients with type 2 diabetes that enable a broader population with impaired renal function to potentially benefit from these important treatment options,” Jim McDermott, PhD, vice president, U.S. medical affairs, diabetes, at AstraZeneca, said in the press release.

Find the full press release on the AstraZeneca website.

[email protected]

The Food and Drug Administration has approved a label extension for Farxiga (dapagliflozin) and Xigduo XR (extended-release dapagliflozin and metformin HCl) for use in patients with type 2 diabetes and moderate renal impairment, lowering the estimated glomerular filtration rate (eGFR) threshold to 45 mL/min per 1.73 m² from the current60 mL/min per 1.73 m².

The update is based on results from DERIVE, a phase 3 study in patients with inadequately controlled diabetes and an eGFR of 45-59 mL/min per 1.73 m² who received either dapagliflozin 10 mg or placebo during a 24-week period. After that time, patients who received dapagliflozin had significant reductions in glycosylated hemoglobin, compared with placebo. The safety profile was similar to that in other studies with dapagliflozin.

The most common adverse events associated with Farxiga are female genital mycotic infections, nasopharyngitis, and urinary tract infections. For Xigduo XR, the most common adverse events are female genital mycotic infection, nasopharyngitis, urinary tract infection, diarrhea, and headache.

“The DERIVE study, which further confirmed the well-established efficacy and safety profile for Farxiga and Xigduo XR, has resulted in important label changes for patients with type 2 diabetes that enable a broader population with impaired renal function to potentially benefit from these important treatment options,” Jim McDermott, PhD, vice president, U.S. medical affairs, diabetes, at AstraZeneca, said in the press release.

Find the full press release on the AstraZeneca website.

[email protected]

SAN DIEGO – A new study of ICU patients in the Netherlands shows a heightened risk of developing new chronic conditions in patients after an intensive care stay. The research showed rising likelihood of conditions such as depression, diabetes, and heart disease.

By merging two existing databases, the researchers were able to capture a more comprehensive picture of post-ICU patients. “We were able to include almost the entire country,” Ilse van Beusekom, a PhD candidate in health sciences at the University of Amsterdam and data manager at the National Intensive Care Evaluation (NICE) foundation, said in an interview.

Ms. van Beusekom presented the study at the Critical Care Congress sponsored by the Society of Critical Care Medicine. The study was simultaneously published in Critical Care Medicine.

The work compared 56,760 ICU survivors from 81 facilities across the Netherlands to 75,232 age-, sex-, and socioeconomic status–matched controls. The mean age was 65 years and 60% of the population was male. “The types of chronic conditions are the same, only the prevalences are different,” said Ms. van Beusekom.

The researchers compared chronic conditions in the year before ICU admission and the year after, based on data pulled from the NICE national quality database, which includes data describing the first 24 hours of ICU admission, and the Vektis insurance claims database, which includes information on medical treatment. Before ICU admission, 45% of the ICU population was free of chronic conditions, as were 62% of controls. One chronic condition was present in 36% of ICU patients, versus 29% of controls, and two or more conditions were present in 19% versus 9% of controls.

The ICU population was more likely to have high cholesterol (16% vs. 14%), heart disease (14% vs. 6%), chronic obstructive pulmonary disease (8% vs. 3%), type II diabetes (8% vs. 6%), type I diabetes (6% vs. 3%), and depression (6% vs. 4%).

The ICU population also was at greater risk of developing one or more new chronic conditions during the year following their stay. The risk was three- to fourfold higher throughout age ranges.

The study suggests the need for greater follow-up after an ICU admission in order to help patients cope with lingering problems. Ms. van Beusekom noted that there are follow-up programs in the Netherlands for several patient groups, but none for ICU survivors. One possibility would be to have the patient return to the ICU 3 months or so after release to discuss their diagnosis, treatment, and any lingering concerns. “A lot of people don’t know that their complaints are linked with the ICU visit,” said Ms. van Beusekom.

Timothy G. Buchman, MD, professor of surgery at Emory University, Atlanta, who moderated the session, wondered why the ICU seems to be an inflection point for developing new chronic conditions. Could it simply be because patients are sicker to begin with and have reached an inflection point of their illness, or could the treatments in ICU be contributing to or exposing those conditions? Ms. van Beusekom believed it was likely a combination of factors, and she referred to data she had not presented showing that even control patients who had been to the hospital (though not the ICU) during the study period were at lower risk of new chronic conditions than ICU patients.

Ms. van Beusekom’s group plans to investigate ICU-related variables that might be associated with risk of chronic conditions.

The study was not funded. Ms. van Beusekom had no relevant disclosures.

SOURCE: van Beusekom I et al. CCC48, Abstract Crit Care Med. 2019;47:324-30.

SAN DIEGO – A new study of ICU patients in the Netherlands shows a heightened risk of developing new chronic conditions in patients after an intensive care stay. The research showed rising likelihood of conditions such as depression, diabetes, and heart disease.

By merging two existing databases, the researchers were able to capture a more comprehensive picture of post-ICU patients. “We were able to include almost the entire country,” Ilse van Beusekom, a PhD candidate in health sciences at the University of Amsterdam and data manager at the National Intensive Care Evaluation (NICE) foundation, said in an interview.

Ms. van Beusekom presented the study at the Critical Care Congress sponsored by the Society of Critical Care Medicine. The study was simultaneously published in Critical Care Medicine.

The work compared 56,760 ICU survivors from 81 facilities across the Netherlands to 75,232 age-, sex-, and socioeconomic status–matched controls. The mean age was 65 years and 60% of the population was male. “The types of chronic conditions are the same, only the prevalences are different,” said Ms. van Beusekom.

The researchers compared chronic conditions in the year before ICU admission and the year after, based on data pulled from the NICE national quality database, which includes data describing the first 24 hours of ICU admission, and the Vektis insurance claims database, which includes information on medical treatment. Before ICU admission, 45% of the ICU population was free of chronic conditions, as were 62% of controls. One chronic condition was present in 36% of ICU patients, versus 29% of controls, and two or more conditions were present in 19% versus 9% of controls.

The ICU population was more likely to have high cholesterol (16% vs. 14%), heart disease (14% vs. 6%), chronic obstructive pulmonary disease (8% vs. 3%), type II diabetes (8% vs. 6%), type I diabetes (6% vs. 3%), and depression (6% vs. 4%).

The ICU population also was at greater risk of developing one or more new chronic conditions during the year following their stay. The risk was three- to fourfold higher throughout age ranges.

The study suggests the need for greater follow-up after an ICU admission in order to help patients cope with lingering problems. Ms. van Beusekom noted that there are follow-up programs in the Netherlands for several patient groups, but none for ICU survivors. One possibility would be to have the patient return to the ICU 3 months or so after release to discuss their diagnosis, treatment, and any lingering concerns. “A lot of people don’t know that their complaints are linked with the ICU visit,” said Ms. van Beusekom.

Timothy G. Buchman, MD, professor of surgery at Emory University, Atlanta, who moderated the session, wondered why the ICU seems to be an inflection point for developing new chronic conditions. Could it simply be because patients are sicker to begin with and have reached an inflection point of their illness, or could the treatments in ICU be contributing to or exposing those conditions? Ms. van Beusekom believed it was likely a combination of factors, and she referred to data she had not presented showing that even control patients who had been to the hospital (though not the ICU) during the study period were at lower risk of new chronic conditions than ICU patients.

Ms. van Beusekom’s group plans to investigate ICU-related variables that might be associated with risk of chronic conditions.

The study was not funded. Ms. van Beusekom had no relevant disclosures.

SOURCE: van Beusekom I et al. CCC48, Abstract Crit Care Med. 2019;47:324-30.

SAN DIEGO – A new study of ICU patients in the Netherlands shows a heightened risk of developing new chronic conditions in patients after an intensive care stay. The research showed rising likelihood of conditions such as depression, diabetes, and heart disease.

By merging two existing databases, the researchers were able to capture a more comprehensive picture of post-ICU patients. “We were able to include almost the entire country,” Ilse van Beusekom, a PhD candidate in health sciences at the University of Amsterdam and data manager at the National Intensive Care Evaluation (NICE) foundation, said in an interview.

Ms. van Beusekom presented the study at the Critical Care Congress sponsored by the Society of Critical Care Medicine. The study was simultaneously published in Critical Care Medicine.

The work compared 56,760 ICU survivors from 81 facilities across the Netherlands to 75,232 age-, sex-, and socioeconomic status–matched controls. The mean age was 65 years and 60% of the population was male. “The types of chronic conditions are the same, only the prevalences are different,” said Ms. van Beusekom.

The researchers compared chronic conditions in the year before ICU admission and the year after, based on data pulled from the NICE national quality database, which includes data describing the first 24 hours of ICU admission, and the Vektis insurance claims database, which includes information on medical treatment. Before ICU admission, 45% of the ICU population was free of chronic conditions, as were 62% of controls. One chronic condition was present in 36% of ICU patients, versus 29% of controls, and two or more conditions were present in 19% versus 9% of controls.

The ICU population was more likely to have high cholesterol (16% vs. 14%), heart disease (14% vs. 6%), chronic obstructive pulmonary disease (8% vs. 3%), type II diabetes (8% vs. 6%), type I diabetes (6% vs. 3%), and depression (6% vs. 4%).

The ICU population also was at greater risk of developing one or more new chronic conditions during the year following their stay. The risk was three- to fourfold higher throughout age ranges.

The study suggests the need for greater follow-up after an ICU admission in order to help patients cope with lingering problems. Ms. van Beusekom noted that there are follow-up programs in the Netherlands for several patient groups, but none for ICU survivors. One possibility would be to have the patient return to the ICU 3 months or so after release to discuss their diagnosis, treatment, and any lingering concerns. “A lot of people don’t know that their complaints are linked with the ICU visit,” said Ms. van Beusekom.

Timothy G. Buchman, MD, professor of surgery at Emory University, Atlanta, who moderated the session, wondered why the ICU seems to be an inflection point for developing new chronic conditions. Could it simply be because patients are sicker to begin with and have reached an inflection point of their illness, or could the treatments in ICU be contributing to or exposing those conditions? Ms. van Beusekom believed it was likely a combination of factors, and she referred to data she had not presented showing that even control patients who had been to the hospital (though not the ICU) during the study period were at lower risk of new chronic conditions than ICU patients.

Ms. van Beusekom’s group plans to investigate ICU-related variables that might be associated with risk of chronic conditions.

The study was not funded. Ms. van Beusekom had no relevant disclosures.

SOURCE: van Beusekom I et al. CCC48, Abstract Crit Care Med. 2019;47:324-30.

The maker of ticagrelor has released top-line results from the phase 3 trial known as THEMIS.

AstraZeneca announced that THEMIS met its primary endpoint of reduction of major adverse cardiovascular events (MACE) among patients with coronary artery disease (CAD) and type 2 diabetes with no history of heart attack or stroke. (MACE is a composite of cardiovascular death, heart attack, and stroke.)

The trial (NCT01991795) explored these risks by comparing ticagrelor (Brilinta) plus aspirin versus aspirin alone. The oral, reversibly binding, direct-acting P2Y₁₂ receptor antagonist is currently indicated for reducing MACE among patients with acute coronary syndrome or a history of MI. According to the press release, the multinational, randomized, double-blind trial is exploring the use of ticagrelor/aspirin among patients with CAD and type 2 diabetes because of this population’s high risk and the lack of treatment options.

Gabriel Steg, MD, THEMIS cochair and professor at Université Paris–Diderot, said in the release that “patients who have both stable coronary artery disease and diabetes are a sizable group which remains at particularly high risk of major adverse cardiac events. The optimal long-term antiplatelet therapy in that group is not fully established.” He added that the full results from the THEMIS trial will be presented later this year.

Ticagrelor comes with risks of significant and sometimes fatal bleeding; as such it is contraindicated for patients with pathological bleeding risk or history of intracranial hemorrhage. Its use is also discouraged among patients with severe hepatic impairment and in patients who are breastfeeding. Although usually self-limiting when related to ticagrelor use, dyspnea was reported in about 14% of patients taking the drug. Dyspnea and bleeding were among the most common adverse reactions seen with ticagrelor.

[email protected]

The maker of ticagrelor has released top-line results from the phase 3 trial known as THEMIS.

AstraZeneca announced that THEMIS met its primary endpoint of reduction of major adverse cardiovascular events (MACE) among patients with coronary artery disease (CAD) and type 2 diabetes with no history of heart attack or stroke. (MACE is a composite of cardiovascular death, heart attack, and stroke.)

The trial (NCT01991795) explored these risks by comparing ticagrelor (Brilinta) plus aspirin versus aspirin alone. The oral, reversibly binding, direct-acting P2Y₁₂ receptor antagonist is currently indicated for reducing MACE among patients with acute coronary syndrome or a history of MI. According to the press release, the multinational, randomized, double-blind trial is exploring the use of ticagrelor/aspirin among patients with CAD and type 2 diabetes because of this population’s high risk and the lack of treatment options.

Gabriel Steg, MD, THEMIS cochair and professor at Université Paris–Diderot, said in the release that “patients who have both stable coronary artery disease and diabetes are a sizable group which remains at particularly high risk of major adverse cardiac events. The optimal long-term antiplatelet therapy in that group is not fully established.” He added that the full results from the THEMIS trial will be presented later this year.

Ticagrelor comes with risks of significant and sometimes fatal bleeding; as such it is contraindicated for patients with pathological bleeding risk or history of intracranial hemorrhage. Its use is also discouraged among patients with severe hepatic impairment and in patients who are breastfeeding. Although usually self-limiting when related to ticagrelor use, dyspnea was reported in about 14% of patients taking the drug. Dyspnea and bleeding were among the most common adverse reactions seen with ticagrelor.

[email protected]

The maker of ticagrelor has released top-line results from the phase 3 trial known as THEMIS.

AstraZeneca announced that THEMIS met its primary endpoint of reduction of major adverse cardiovascular events (MACE) among patients with coronary artery disease (CAD) and type 2 diabetes with no history of heart attack or stroke. (MACE is a composite of cardiovascular death, heart attack, and stroke.)

The trial (NCT01991795) explored these risks by comparing ticagrelor (Brilinta) plus aspirin versus aspirin alone. The oral, reversibly binding, direct-acting P2Y₁₂ receptor antagonist is currently indicated for reducing MACE among patients with acute coronary syndrome or a history of MI. According to the press release, the multinational, randomized, double-blind trial is exploring the use of ticagrelor/aspirin among patients with CAD and type 2 diabetes because of this population’s high risk and the lack of treatment options.

Gabriel Steg, MD, THEMIS cochair and professor at Université Paris–Diderot, said in the release that “patients who have both stable coronary artery disease and diabetes are a sizable group which remains at particularly high risk of major adverse cardiac events. The optimal long-term antiplatelet therapy in that group is not fully established.” He added that the full results from the THEMIS trial will be presented later this year.

Ticagrelor comes with risks of significant and sometimes fatal bleeding; as such it is contraindicated for patients with pathological bleeding risk or history of intracranial hemorrhage. Its use is also discouraged among patients with severe hepatic impairment and in patients who are breastfeeding. Although usually self-limiting when related to ticagrelor use, dyspnea was reported in about 14% of patients taking the drug. Dyspnea and bleeding were among the most common adverse reactions seen with ticagrelor.

[email protected]

Mortality after the use of drug-coated balloons (DCB) for femoropopliteal peripheral arterial disease (PAD) was not correlated with paclitaxel exposure, according to the results of a meta-analysis of 5-year outcomes, according to a report published online.

“Paclitaxel DCBs are safe and effective to treat the symptoms of [Rutherford classification categories] 2-4 femoropopliteal PAD,” according to Peter A. Schneider, MD, of Hawaii Permanente Medical Group, Kaiser Foundation Hospital, Honolulu, and his coauthors.

Their study analyzed data pooled from five clinical trials NCT01175850, NCT01566461, NCT01947478, NCT02118532, and NCT01609296, comprising 1,980 patients from a variety of ethnic populations with Rutherford classification 2-4 disease.

Among these patients, 1,837 received DCB and 143 received uncoated percutaneous transluminal angioplasty (PTA). The mean age of the overall cohort was 68.5 years; 68.4% of patients were men. Baseline characteristics were similar between groups. However, patients treated with a DCB were more likely to have critical limb ischemia, compared with PTA. DCB subjects were less likely to have hyperlipidemia, coronary artery disease, and diabetes mellitus than were those treated with uncoated PTA. In addition, PTA patients who died were more likely to be active smokers than were DCB patients that died.

There was no statistically significant difference in all-cause mortality between DCB and PTA through 5 years (9.3% vs 11.2%, respectively, P = .399).

A Kaplan-Meier survival analysis stratified paclitaxel dosage into three groups: low-dose, mid-dose, and upper-dose groups. Mean dosages for the three groups were 5,019, 10,008, and 19,978 mcg, respectively. The analysis showed no significant difference in mortality between groups, “demonstrating no direct impact of levels of nominal paclitaxel dose exposure at the index procedure and survival status in the DCB patients through 5 years (P = .700),” according to the authors.

Limitations of the study reported by the authors include the fact that pooling data from distinct trials has shortcomings. Some of data included had not yet undergone peer review, and PTA patients were included in only two randomized trials in a 2:1 ratio.

“The small numbers of PTA control patients (less than 10%) may not be representative of PTA patients in general and limits the strength of this analysis of mortality.” In addition, only patients with Rutherford classification 2-4 were included in these studies.

“Results from this independent patient-level meta-analysis show no difference in mortality between DCB and PTA at 5 years and no correlation between varying levels of paclitaxel exposure and mortality. ... Data transparency and additional analyses are needed to better understand how other factors influence long-term outcomes in this complex patient population,” the researchers concluded.

The study was funded by Medtronic, which provided the data for independent analysis to the Baim Institute for Clinical Research. Dr. Schneider is a member of the advisory board for Medtronic, Abbott, and Boston Scientific and is a consultant for Medtronic and other device companies. Coauthors had consulting, advisory board, or honoraria relationships with Medtronic and other device companies.

[email protected]

SOURCE: Schneider PA et al. JACC 2019 Jan 25. doi: 10.1016/j.jacc.2019.01.013.

Mortality after the use of drug-coated balloons (DCB) for femoropopliteal peripheral arterial disease (PAD) was not correlated with paclitaxel exposure, according to the results of a meta-analysis of 5-year outcomes, according to a report published online.

“Paclitaxel DCBs are safe and effective to treat the symptoms of [Rutherford classification categories] 2-4 femoropopliteal PAD,” according to Peter A. Schneider, MD, of Hawaii Permanente Medical Group, Kaiser Foundation Hospital, Honolulu, and his coauthors.

Their study analyzed data pooled from five clinical trials NCT01175850, NCT01566461, NCT01947478, NCT02118532, and NCT01609296, comprising 1,980 patients from a variety of ethnic populations with Rutherford classification 2-4 disease.

Among these patients, 1,837 received DCB and 143 received uncoated percutaneous transluminal angioplasty (PTA). The mean age of the overall cohort was 68.5 years; 68.4% of patients were men. Baseline characteristics were similar between groups. However, patients treated with a DCB were more likely to have critical limb ischemia, compared with PTA. DCB subjects were less likely to have hyperlipidemia, coronary artery disease, and diabetes mellitus than were those treated with uncoated PTA. In addition, PTA patients who died were more likely to be active smokers than were DCB patients that died.

There was no statistically significant difference in all-cause mortality between DCB and PTA through 5 years (9.3% vs 11.2%, respectively, P = .399).

A Kaplan-Meier survival analysis stratified paclitaxel dosage into three groups: low-dose, mid-dose, and upper-dose groups. Mean dosages for the three groups were 5,019, 10,008, and 19,978 mcg, respectively. The analysis showed no significant difference in mortality between groups, “demonstrating no direct impact of levels of nominal paclitaxel dose exposure at the index procedure and survival status in the DCB patients through 5 years (P = .700),” according to the authors.

Limitations of the study reported by the authors include the fact that pooling data from distinct trials has shortcomings. Some of data included had not yet undergone peer review, and PTA patients were included in only two randomized trials in a 2:1 ratio.

“The small numbers of PTA control patients (less than 10%) may not be representative of PTA patients in general and limits the strength of this analysis of mortality.” In addition, only patients with Rutherford classification 2-4 were included in these studies.

“Results from this independent patient-level meta-analysis show no difference in mortality between DCB and PTA at 5 years and no correlation between varying levels of paclitaxel exposure and mortality. ... Data transparency and additional analyses are needed to better understand how other factors influence long-term outcomes in this complex patient population,” the researchers concluded.

The study was funded by Medtronic, which provided the data for independent analysis to the Baim Institute for Clinical Research. Dr. Schneider is a member of the advisory board for Medtronic, Abbott, and Boston Scientific and is a consultant for Medtronic and other device companies. Coauthors had consulting, advisory board, or honoraria relationships with Medtronic and other device companies.

[email protected]

SOURCE: Schneider PA et al. JACC 2019 Jan 25. doi: 10.1016/j.jacc.2019.01.013.

Mortality after the use of drug-coated balloons (DCB) for femoropopliteal peripheral arterial disease (PAD) was not correlated with paclitaxel exposure, according to the results of a meta-analysis of 5-year outcomes, according to a report published online.

“Paclitaxel DCBs are safe and effective to treat the symptoms of [Rutherford classification categories] 2-4 femoropopliteal PAD,” according to Peter A. Schneider, MD, of Hawaii Permanente Medical Group, Kaiser Foundation Hospital, Honolulu, and his coauthors.

Their study analyzed data pooled from five clinical trials NCT01175850, NCT01566461, NCT01947478, NCT02118532, and NCT01609296, comprising 1,980 patients from a variety of ethnic populations with Rutherford classification 2-4 disease.

Among these patients, 1,837 received DCB and 143 received uncoated percutaneous transluminal angioplasty (PTA). The mean age of the overall cohort was 68.5 years; 68.4% of patients were men. Baseline characteristics were similar between groups. However, patients treated with a DCB were more likely to have critical limb ischemia, compared with PTA. DCB subjects were less likely to have hyperlipidemia, coronary artery disease, and diabetes mellitus than were those treated with uncoated PTA. In addition, PTA patients who died were more likely to be active smokers than were DCB patients that died.

There was no statistically significant difference in all-cause mortality between DCB and PTA through 5 years (9.3% vs 11.2%, respectively, P = .399).

A Kaplan-Meier survival analysis stratified paclitaxel dosage into three groups: low-dose, mid-dose, and upper-dose groups. Mean dosages for the three groups were 5,019, 10,008, and 19,978 mcg, respectively. The analysis showed no significant difference in mortality between groups, “demonstrating no direct impact of levels of nominal paclitaxel dose exposure at the index procedure and survival status in the DCB patients through 5 years (P = .700),” according to the authors.

Limitations of the study reported by the authors include the fact that pooling data from distinct trials has shortcomings. Some of data included had not yet undergone peer review, and PTA patients were included in only two randomized trials in a 2:1 ratio.

“The small numbers of PTA control patients (less than 10%) may not be representative of PTA patients in general and limits the strength of this analysis of mortality.” In addition, only patients with Rutherford classification 2-4 were included in these studies.

“Results from this independent patient-level meta-analysis show no difference in mortality between DCB and PTA at 5 years and no correlation between varying levels of paclitaxel exposure and mortality. ... Data transparency and additional analyses are needed to better understand how other factors influence long-term outcomes in this complex patient population,” the researchers concluded.

The study was funded by Medtronic, which provided the data for independent analysis to the Baim Institute for Clinical Research. Dr. Schneider is a member of the advisory board for Medtronic, Abbott, and Boston Scientific and is a consultant for Medtronic and other device companies. Coauthors had consulting, advisory board, or honoraria relationships with Medtronic and other device companies.

[email protected]

SOURCE: Schneider PA et al. JACC 2019 Jan 25. doi: 10.1016/j.jacc.2019.01.013.

A 60-year-old man is sent by his new employer to your urgent care for a pre-employment Department of Transportation (DOT) physical to obtain clearance to drive a commercial motor vehicle. His medical history is significant for hypertension, for which he takes lisinopril. Otherwise, he is healthy, with normal vital signs. His physical exam is unremarkable, but the urine sample is notably positive for glucose. A fingerstick glucose test yields a measurement of 212 mg/dL. What is your next appropriate step to medically clear the patient to drive commercially?

Commercial motor vehicle (CMV) drivers are mandated by the Federal Motor Carrier Safety Administration (FMCSA) to receive a DOT physical examination by a licensed medical examiner. To qualify to perform the exam, physician assistants, advanced practice nurses, physicians, and chiropractors must complete an educational program and pass a written certification examination.¹ Subsequently, the examiners are placed on a national registry—the National Registry of Certified Medical Examiners—with the mission to improve highway safety by determining whether a CMV driver’s health meets standards and guidelines set by the FMCSA.²

Under current guidelines, a DOT physical exam for a healthy CMV driver is considered valid for a maximum of 24 months. However, some diseases and medications require frequent follow-up, which can shorten the length of time a driver can be medically cleared to operate a CMV. Furthermore, certain conditions can disqualify the driver from meeting the necessary standards required for medical certification.

This case presentation offers the opportunity to review the requirements for evaluation and certification of a CMV driver with new-onset hyperglycemia and, ultimately, diabetes. In the United States, types 1 and 2 diabetes are estimated to affect 30.3 million people.³ About 33% of CMV drivers have been diagnosed with diabetes, which is significant since research has demonstrated an increased risk for crashes in individuals with diabetes, due to potential incapacitation from hypoglycemia.^4-6

Thus, for practitioners and medical examiners, it is prudent to screen and manage diabetes in CMV drivers. In fact, over the past 15 years, federal regulations have stipulated that any driver with diabetes requiring insulin for control was disqualified from this type of work.⁷ This standard was developed in response to the increased risk for hypoglycemic reactions with the use of insulin. However, in September 2018, the FMCSA revised this regulation, permitting individuals with a stable insulin regimen and properly controlled diabetes to be qualified to operate a CMV. As a result, for drivers requiring insulin, the treating clinician must complete a standardized form within 45 days of the DOT exam, documenting management of the patient’s diabetes.⁸ For drivers with diabetes who do not require insulin, determinations are made on a case-by-case basis, with discernment of the driver’s ability to manage the disease and concurrently meet other standards for qualification.

HEALTH HISTORY AND EXAMINATION

Each CMV driver completes a standard medical history form that asks about specific medications, surgeries, or medical conditions, including diabetes or blood glucose problems. Subsequently, the driver and, ultimately, the medical examiner must expand upon and discuss every “yes” response to this questionnaire.

Regarding diabetes, the examiner should determine whether the disease is controlled by diet, pills, and/or insulin, with clarification of the doses, frequency, and prescriber. In addition, the examiner should review and document glucose control, blood glucose monitoring, history of hypoglycemic episodes, and episodes of fainting, dizziness, or loss of consciousness.⁷

Continue to: The physical exam should focus on...

The physical exam should focus on identifying signs of complications from diabetes, such as retinopathy, nephropathy, or peripheral neuropathy. At each certification visit, the examiner should assess the patient’s height and weight, BMI, vision, hearing, blood pressure, and heart rate, and perform urinalysis to screen for proteinuria or glycosuria. A fingerstick test to obtain a random blood glucose reading is often performed in a driver with glycosuria.

Likewise, the A1C level should be documented in every patient with new-onset or known diabetes, with the recommendation from the FMCSA that a level >10% is an indicator of poor glucose control.⁷ It is important to note that an A1C level up to 10% is not the glycemic target recognized by the American Diabetes Association and the American Association of Clinical Endocrinologists. The FMCSA is focused more on hypoglycemic concerns than on providing management guidelines.

DETERMINING CERTIFICATION

Currently, the recertification time recommended for CMV drivers with diabetes and documented glucose control is 1 year. This is based on the assumption that the driver is under medical care with a treatment plan and that he/she is not currently experiencing any complications from the disease. Furthermore, insulin secretagogues (eg, sulfonylureas) can be used for glucose control as long as adverse effects (eg, hypoglycemia) do not interfere with safe driving. However, the FMCSA does not recommend certifying any driver who

• In the past 12 months has experienced a hypoglycemic reaction resulting in seizure; loss of consciousness; need of assistance from another person; or period of impaired cognitive function that occurred without warning.
• In the past 5 years has had recurring (≥ 2) disqualifying hypoglycemic reactions.
• Has received a formal diagnosis of peripheral neuropathy, loss of position, or pedal sensation.
• Has resting tachycardia or orthostatic hypotension.
• Has severe diabetic nephropathy requiring dialysis.
• Has severe nonproliferative or proliferative retinopathy.⁸

In drivers with new-onset hyperglycemia, it is appropriate for the medical examiner to refer the driver to his/her primary care provider for further testing (eg, A1C), determination of treatment, a copy of the diabetes medical standard for driving, and written opinion of the driver’s medical fitness for duty. Subsequently, the medical examiner can utilize this information from the primary care provider to determine certification for the driver. While there are no specific guidelines on the waiting period for certification, the driver should demonstrate glucose control with treatment that is adequate, effective, safe, and stable.⁷

Overall, while living with diabetes can be challenging, patients who demonstrate control of the disease can maintain their occupation as a CMV driver. The role of the medical examiner is to evaluate the driver’s risk to safely operate a CMV—in particular, considering the possibilities of a severe hypoglycemic episode or target organ dysfunction—whereas the clinician treating the driver’s diabetes is focused on minimizing the complications associated with hyperglycemia.

Continue to: As a reminder...

As a reminder, due to the progressive nature of the disease, recertification is recommended annually for drivers.⁷ Nevertheless, it is reassuring that the DOT has implemented safeguards designed to keep our citizens safe while travelling the highways and byways of the United States.

Given the patient’s elevated glucose, more information is needed to safely provide clearance for driving a CMV. The patient would be disqualified until he could provide documentation of glucose control. Therefore, this patient would benefit from a referral to his primary care provider to obtain a list of medications used to manage his disease, documentation of an A1C level <10% and no evidence of complications from diabetes, and a written opinion from the primary care provider indicating the driver is medically fit for duty. Accordingly, the primary care provider can ensure the patient demonstrates compliance in managing diabetes and can safely operate a CMV.

A 60-year-old man is sent by his new employer to your urgent care for a pre-employment Department of Transportation (DOT) physical to obtain clearance to drive a commercial motor vehicle. His medical history is significant for hypertension, for which he takes lisinopril. Otherwise, he is healthy, with normal vital signs. His physical exam is unremarkable, but the urine sample is notably positive for glucose. A fingerstick glucose test yields a measurement of 212 mg/dL. What is your next appropriate step to medically clear the patient to drive commercially?

Commercial motor vehicle (CMV) drivers are mandated by the Federal Motor Carrier Safety Administration (FMCSA) to receive a DOT physical examination by a licensed medical examiner. To qualify to perform the exam, physician assistants, advanced practice nurses, physicians, and chiropractors must complete an educational program and pass a written certification examination.¹ Subsequently, the examiners are placed on a national registry—the National Registry of Certified Medical Examiners—with the mission to improve highway safety by determining whether a CMV driver’s health meets standards and guidelines set by the FMCSA.²

Under current guidelines, a DOT physical exam for a healthy CMV driver is considered valid for a maximum of 24 months. However, some diseases and medications require frequent follow-up, which can shorten the length of time a driver can be medically cleared to operate a CMV. Furthermore, certain conditions can disqualify the driver from meeting the necessary standards required for medical certification.

This case presentation offers the opportunity to review the requirements for evaluation and certification of a CMV driver with new-onset hyperglycemia and, ultimately, diabetes. In the United States, types 1 and 2 diabetes are estimated to affect 30.3 million people.³ About 33% of CMV drivers have been diagnosed with diabetes, which is significant since research has demonstrated an increased risk for crashes in individuals with diabetes, due to potential incapacitation from hypoglycemia.^4-6

Thus, for practitioners and medical examiners, it is prudent to screen and manage diabetes in CMV drivers. In fact, over the past 15 years, federal regulations have stipulated that any driver with diabetes requiring insulin for control was disqualified from this type of work.⁷ This standard was developed in response to the increased risk for hypoglycemic reactions with the use of insulin. However, in September 2018, the FMCSA revised this regulation, permitting individuals with a stable insulin regimen and properly controlled diabetes to be qualified to operate a CMV. As a result, for drivers requiring insulin, the treating clinician must complete a standardized form within 45 days of the DOT exam, documenting management of the patient’s diabetes.⁸ For drivers with diabetes who do not require insulin, determinations are made on a case-by-case basis, with discernment of the driver’s ability to manage the disease and concurrently meet other standards for qualification.

HEALTH HISTORY AND EXAMINATION

Each CMV driver completes a standard medical history form that asks about specific medications, surgeries, or medical conditions, including diabetes or blood glucose problems. Subsequently, the driver and, ultimately, the medical examiner must expand upon and discuss every “yes” response to this questionnaire.

Regarding diabetes, the examiner should determine whether the disease is controlled by diet, pills, and/or insulin, with clarification of the doses, frequency, and prescriber. In addition, the examiner should review and document glucose control, blood glucose monitoring, history of hypoglycemic episodes, and episodes of fainting, dizziness, or loss of consciousness.⁷

Continue to: The physical exam should focus on...

The physical exam should focus on identifying signs of complications from diabetes, such as retinopathy, nephropathy, or peripheral neuropathy. At each certification visit, the examiner should assess the patient’s height and weight, BMI, vision, hearing, blood pressure, and heart rate, and perform urinalysis to screen for proteinuria or glycosuria. A fingerstick test to obtain a random blood glucose reading is often performed in a driver with glycosuria.

Likewise, the A1C level should be documented in every patient with new-onset or known diabetes, with the recommendation from the FMCSA that a level >10% is an indicator of poor glucose control.⁷ It is important to note that an A1C level up to 10% is not the glycemic target recognized by the American Diabetes Association and the American Association of Clinical Endocrinologists. The FMCSA is focused more on hypoglycemic concerns than on providing management guidelines.

DETERMINING CERTIFICATION

Currently, the recertification time recommended for CMV drivers with diabetes and documented glucose control is 1 year. This is based on the assumption that the driver is under medical care with a treatment plan and that he/she is not currently experiencing any complications from the disease. Furthermore, insulin secretagogues (eg, sulfonylureas) can be used for glucose control as long as adverse effects (eg, hypoglycemia) do not interfere with safe driving. However, the FMCSA does not recommend certifying any driver who

• In the past 12 months has experienced a hypoglycemic reaction resulting in seizure; loss of consciousness; need of assistance from another person; or period of impaired cognitive function that occurred without warning.
• In the past 5 years has had recurring (≥ 2) disqualifying hypoglycemic reactions.
• Has received a formal diagnosis of peripheral neuropathy, loss of position, or pedal sensation.
• Has resting tachycardia or orthostatic hypotension.
• Has severe diabetic nephropathy requiring dialysis.
• Has severe nonproliferative or proliferative retinopathy.⁸

In drivers with new-onset hyperglycemia, it is appropriate for the medical examiner to refer the driver to his/her primary care provider for further testing (eg, A1C), determination of treatment, a copy of the diabetes medical standard for driving, and written opinion of the driver’s medical fitness for duty. Subsequently, the medical examiner can utilize this information from the primary care provider to determine certification for the driver. While there are no specific guidelines on the waiting period for certification, the driver should demonstrate glucose control with treatment that is adequate, effective, safe, and stable.⁷

Overall, while living with diabetes can be challenging, patients who demonstrate control of the disease can maintain their occupation as a CMV driver. The role of the medical examiner is to evaluate the driver’s risk to safely operate a CMV—in particular, considering the possibilities of a severe hypoglycemic episode or target organ dysfunction—whereas the clinician treating the driver’s diabetes is focused on minimizing the complications associated with hyperglycemia.

Continue to: As a reminder...

As a reminder, due to the progressive nature of the disease, recertification is recommended annually for drivers.⁷ Nevertheless, it is reassuring that the DOT has implemented safeguards designed to keep our citizens safe while travelling the highways and byways of the United States.

Given the patient’s elevated glucose, more information is needed to safely provide clearance for driving a CMV. The patient would be disqualified until he could provide documentation of glucose control. Therefore, this patient would benefit from a referral to his primary care provider to obtain a list of medications used to manage his disease, documentation of an A1C level <10% and no evidence of complications from diabetes, and a written opinion from the primary care provider indicating the driver is medically fit for duty. Accordingly, the primary care provider can ensure the patient demonstrates compliance in managing diabetes and can safely operate a CMV.

A 60-year-old man is sent by his new employer to your urgent care for a pre-employment Department of Transportation (DOT) physical to obtain clearance to drive a commercial motor vehicle. His medical history is significant for hypertension, for which he takes lisinopril. Otherwise, he is healthy, with normal vital signs. His physical exam is unremarkable, but the urine sample is notably positive for glucose. A fingerstick glucose test yields a measurement of 212 mg/dL. What is your next appropriate step to medically clear the patient to drive commercially?

Commercial motor vehicle (CMV) drivers are mandated by the Federal Motor Carrier Safety Administration (FMCSA) to receive a DOT physical examination by a licensed medical examiner. To qualify to perform the exam, physician assistants, advanced practice nurses, physicians, and chiropractors must complete an educational program and pass a written certification examination.¹ Subsequently, the examiners are placed on a national registry—the National Registry of Certified Medical Examiners—with the mission to improve highway safety by determining whether a CMV driver’s health meets standards and guidelines set by the FMCSA.²

Under current guidelines, a DOT physical exam for a healthy CMV driver is considered valid for a maximum of 24 months. However, some diseases and medications require frequent follow-up, which can shorten the length of time a driver can be medically cleared to operate a CMV. Furthermore, certain conditions can disqualify the driver from meeting the necessary standards required for medical certification.

This case presentation offers the opportunity to review the requirements for evaluation and certification of a CMV driver with new-onset hyperglycemia and, ultimately, diabetes. In the United States, types 1 and 2 diabetes are estimated to affect 30.3 million people.³ About 33% of CMV drivers have been diagnosed with diabetes, which is significant since research has demonstrated an increased risk for crashes in individuals with diabetes, due to potential incapacitation from hypoglycemia.^4-6

Thus, for practitioners and medical examiners, it is prudent to screen and manage diabetes in CMV drivers. In fact, over the past 15 years, federal regulations have stipulated that any driver with diabetes requiring insulin for control was disqualified from this type of work.⁷ This standard was developed in response to the increased risk for hypoglycemic reactions with the use of insulin. However, in September 2018, the FMCSA revised this regulation, permitting individuals with a stable insulin regimen and properly controlled diabetes to be qualified to operate a CMV. As a result, for drivers requiring insulin, the treating clinician must complete a standardized form within 45 days of the DOT exam, documenting management of the patient’s diabetes.⁸ For drivers with diabetes who do not require insulin, determinations are made on a case-by-case basis, with discernment of the driver’s ability to manage the disease and concurrently meet other standards for qualification.

HEALTH HISTORY AND EXAMINATION

Each CMV driver completes a standard medical history form that asks about specific medications, surgeries, or medical conditions, including diabetes or blood glucose problems. Subsequently, the driver and, ultimately, the medical examiner must expand upon and discuss every “yes” response to this questionnaire.

Regarding diabetes, the examiner should determine whether the disease is controlled by diet, pills, and/or insulin, with clarification of the doses, frequency, and prescriber. In addition, the examiner should review and document glucose control, blood glucose monitoring, history of hypoglycemic episodes, and episodes of fainting, dizziness, or loss of consciousness.⁷

Continue to: The physical exam should focus on...

The physical exam should focus on identifying signs of complications from diabetes, such as retinopathy, nephropathy, or peripheral neuropathy. At each certification visit, the examiner should assess the patient’s height and weight, BMI, vision, hearing, blood pressure, and heart rate, and perform urinalysis to screen for proteinuria or glycosuria. A fingerstick test to obtain a random blood glucose reading is often performed in a driver with glycosuria.

Likewise, the A1C level should be documented in every patient with new-onset or known diabetes, with the recommendation from the FMCSA that a level >10% is an indicator of poor glucose control.⁷ It is important to note that an A1C level up to 10% is not the glycemic target recognized by the American Diabetes Association and the American Association of Clinical Endocrinologists. The FMCSA is focused more on hypoglycemic concerns than on providing management guidelines.

DETERMINING CERTIFICATION

Currently, the recertification time recommended for CMV drivers with diabetes and documented glucose control is 1 year. This is based on the assumption that the driver is under medical care with a treatment plan and that he/she is not currently experiencing any complications from the disease. Furthermore, insulin secretagogues (eg, sulfonylureas) can be used for glucose control as long as adverse effects (eg, hypoglycemia) do not interfere with safe driving. However, the FMCSA does not recommend certifying any driver who

• In the past 12 months has experienced a hypoglycemic reaction resulting in seizure; loss of consciousness; need of assistance from another person; or period of impaired cognitive function that occurred without warning.
• In the past 5 years has had recurring (≥ 2) disqualifying hypoglycemic reactions.
• Has received a formal diagnosis of peripheral neuropathy, loss of position, or pedal sensation.
• Has resting tachycardia or orthostatic hypotension.
• Has severe diabetic nephropathy requiring dialysis.
• Has severe nonproliferative or proliferative retinopathy.⁸

In drivers with new-onset hyperglycemia, it is appropriate for the medical examiner to refer the driver to his/her primary care provider for further testing (eg, A1C), determination of treatment, a copy of the diabetes medical standard for driving, and written opinion of the driver’s medical fitness for duty. Subsequently, the medical examiner can utilize this information from the primary care provider to determine certification for the driver. While there are no specific guidelines on the waiting period for certification, the driver should demonstrate glucose control with treatment that is adequate, effective, safe, and stable.⁷

Overall, while living with diabetes can be challenging, patients who demonstrate control of the disease can maintain their occupation as a CMV driver. The role of the medical examiner is to evaluate the driver’s risk to safely operate a CMV—in particular, considering the possibilities of a severe hypoglycemic episode or target organ dysfunction—whereas the clinician treating the driver’s diabetes is focused on minimizing the complications associated with hyperglycemia.

Continue to: As a reminder...

As a reminder, due to the progressive nature of the disease, recertification is recommended annually for drivers.⁷ Nevertheless, it is reassuring that the DOT has implemented safeguards designed to keep our citizens safe while travelling the highways and byways of the United States.

Given the patient’s elevated glucose, more information is needed to safely provide clearance for driving a CMV. The patient would be disqualified until he could provide documentation of glucose control. Therefore, this patient would benefit from a referral to his primary care provider to obtain a list of medications used to manage his disease, documentation of an A1C level <10% and no evidence of complications from diabetes, and a written opinion from the primary care provider indicating the driver is medically fit for duty. Accordingly, the primary care provider can ensure the patient demonstrates compliance in managing diabetes and can safely operate a CMV.

Women with insulin-treated diabetes are at significantly greater risk of preterm birth and of delivering babies who are large for gestational age (LGA), regardless of prepregnancy body weight, new findings suggest.

iStock

Researchers examined the role of maternal diabetes and weight on pregnancy outcomes in the population-based cohort study. The study comprised 649,043 live births in Finland between Jan. 1, 2004, and Dec. 31, 2014, including 4,000 in women with insulin-treated diabetes, 3,740 in women with type 2 diabetes, and 98,568 women with gestational diabetes.

Prepregnancy body mass index was normal for nearly 60% of mothers, while 4% were underweight, 21% were overweight, 8% were moderately obese, and 4% were severely obese.

Overall, the researchers found that women with insulin-treated diabetes had a 43-fold higher odds of having an LGA infant, compared with the reference group of women of normal BMI without diabetes (adjusted odds ratio [aOR], 43.80; 95% confidence interval, 40.88-46.93). And there was an 11-fold greater odds of having a preterm birth in this group (aOR, 11.17; 95% CI, 10.46-11.93).

The findings were published in JAMA Pediatrics.

“Smaller, but clearly statistically significant, increased LGA risks were found also for mothers with type 2 diabetes and gestational diabetes not treated with insulin, especially in combination with prepregnancy overweight or obesity that were stronger for type 2 diabetes than gestational diabetes,” wrote Linghua Kong, MSc, of the department of molecular medicine and surgery at Karolinska Institutet, and coauthors.

The aOR for LGA among women with type 2 diabetes was 9.57 (95% CI, 8.65-10.58), compared with the reference group. And for women with maternal gestational diabetes, the aOR for LGA was 3.80 (95% CI, 3.66-3.96).

SOURCE: Kong L et al. JAMA Pediatr. 2019 Feb 25. doi: 10.1001/jamapediatrics.2018.5541.

Women with insulin-treated diabetes are at significantly greater risk of preterm birth and of delivering babies who are large for gestational age (LGA), regardless of prepregnancy body weight, new findings suggest.

iStock

Researchers examined the role of maternal diabetes and weight on pregnancy outcomes in the population-based cohort study. The study comprised 649,043 live births in Finland between Jan. 1, 2004, and Dec. 31, 2014, including 4,000 in women with insulin-treated diabetes, 3,740 in women with type 2 diabetes, and 98,568 women with gestational diabetes.

Prepregnancy body mass index was normal for nearly 60% of mothers, while 4% were underweight, 21% were overweight, 8% were moderately obese, and 4% were severely obese.

Overall, the researchers found that women with insulin-treated diabetes had a 43-fold higher odds of having an LGA infant, compared with the reference group of women of normal BMI without diabetes (adjusted odds ratio [aOR], 43.80; 95% confidence interval, 40.88-46.93). And there was an 11-fold greater odds of having a preterm birth in this group (aOR, 11.17; 95% CI, 10.46-11.93).

The findings were published in JAMA Pediatrics.

“Smaller, but clearly statistically significant, increased LGA risks were found also for mothers with type 2 diabetes and gestational diabetes not treated with insulin, especially in combination with prepregnancy overweight or obesity that were stronger for type 2 diabetes than gestational diabetes,” wrote Linghua Kong, MSc, of the department of molecular medicine and surgery at Karolinska Institutet, and coauthors.

The aOR for LGA among women with type 2 diabetes was 9.57 (95% CI, 8.65-10.58), compared with the reference group. And for women with maternal gestational diabetes, the aOR for LGA was 3.80 (95% CI, 3.66-3.96).

SOURCE: Kong L et al. JAMA Pediatr. 2019 Feb 25. doi: 10.1001/jamapediatrics.2018.5541.

Women with insulin-treated diabetes are at significantly greater risk of preterm birth and of delivering babies who are large for gestational age (LGA), regardless of prepregnancy body weight, new findings suggest.

iStock

Researchers examined the role of maternal diabetes and weight on pregnancy outcomes in the population-based cohort study. The study comprised 649,043 live births in Finland between Jan. 1, 2004, and Dec. 31, 2014, including 4,000 in women with insulin-treated diabetes, 3,740 in women with type 2 diabetes, and 98,568 women with gestational diabetes.

Prepregnancy body mass index was normal for nearly 60% of mothers, while 4% were underweight, 21% were overweight, 8% were moderately obese, and 4% were severely obese.

Overall, the researchers found that women with insulin-treated diabetes had a 43-fold higher odds of having an LGA infant, compared with the reference group of women of normal BMI without diabetes (adjusted odds ratio [aOR], 43.80; 95% confidence interval, 40.88-46.93). And there was an 11-fold greater odds of having a preterm birth in this group (aOR, 11.17; 95% CI, 10.46-11.93).

The findings were published in JAMA Pediatrics.

“Smaller, but clearly statistically significant, increased LGA risks were found also for mothers with type 2 diabetes and gestational diabetes not treated with insulin, especially in combination with prepregnancy overweight or obesity that were stronger for type 2 diabetes than gestational diabetes,” wrote Linghua Kong, MSc, of the department of molecular medicine and surgery at Karolinska Institutet, and coauthors.

The aOR for LGA among women with type 2 diabetes was 9.57 (95% CI, 8.65-10.58), compared with the reference group. And for women with maternal gestational diabetes, the aOR for LGA was 3.80 (95% CI, 3.66-3.96).

SOURCE: Kong L et al. JAMA Pediatr. 2019 Feb 25. doi: 10.1001/jamapediatrics.2018.5541.