Rates of a potentially deadly overlap between use of nonprescribed fentanyl and use of either cocaine or methamphetamine have been increasing, a cross-sectional study of 1 million urine drug tests shows.

Leah LaRue, PharmD, of Millennium Health in San Diego, and colleagues performed the study, which sampled 1 million urine drug tests submitted by health care professionals “as part of routine care” during Jan. 1, 2013–Sept. 30, 2018. They isolated tests that were positive for either cocaine or methamphetamine – but not positive for both – and then determined how many in each group were also positive for nonprescribed fentanyl. Their analyses showed that the rate of cocaine-positive tests that also were positive for nonprescribed fentanyl increased from 0.9% in 2013 (n = 84; 95% confidence interval, 0.7%-1.1%) to 17.6% in 2018 (n = 427; 95% CI, 16.1%-19.1%), an increase of 1,850% (P less than .001). The rate of methamphetamine-positive tests that also were positive for nonprescribed fentanyl also started at 0.9% in 2013 (n = 29; 95% CI, 0.6%-1.2%) but rose to 7.9% in 2018 (n = 344; 95% CI, 7.1%-8.7%, a 798% increase (P less than .001). The study was published in JAMA Network Open.

The investigators suggested two explanations for these increases: intentional combination of drugs for “speedball effects” of combining stimulants and depressants and/or unintentional exposure on the part of users through contamination of substances. There have been increases in both cocaine-related and methamphetamine-related deaths, and the investigators of this study suspect these increases could be explained in part by overlap with opioids such as fentanyl. Part of the overdose risk inherent in these combinations is that, as the stimulant wears off, the fentanyl increasingly depresses the respiratory system, according to investigators; alternatively, opioid-naive stimulant users might be exposed to high levels of fentanyl with no opioid tolerance, which also can lead to overdose.

The study’s limitations include how samples were submitted – by health care professionals as part of routine care – and the possibility that individuals’ list of prescribed medications could have been incomplete or inaccurate such that the presence of prescribed fentanyl was counted as nonprescribed.

“The combination of nonprescribed fentanyl with cocaine or methamphetamine places an individual at increased risk of overdose,” they concluded. “Clinicians treating these individuals, and the individuals themselves, should be aware of this risk. Additionally, efforts should be made to educate the public about this risk and about overdose prevention.”

cpalmer@mdedge.com

SOURCE: LaRue L et al. JAMA Netw Open. 2019 Apr 26. doi: 10.1001/jamanetworkopen.2019.2851.

Rates of a potentially deadly overlap between use of nonprescribed fentanyl and use of either cocaine or methamphetamine have been increasing, a cross-sectional study of 1 million urine drug tests shows.

Leah LaRue, PharmD, of Millennium Health in San Diego, and colleagues performed the study, which sampled 1 million urine drug tests submitted by health care professionals “as part of routine care” during Jan. 1, 2013–Sept. 30, 2018. They isolated tests that were positive for either cocaine or methamphetamine – but not positive for both – and then determined how many in each group were also positive for nonprescribed fentanyl. Their analyses showed that the rate of cocaine-positive tests that also were positive for nonprescribed fentanyl increased from 0.9% in 2013 (n = 84; 95% confidence interval, 0.7%-1.1%) to 17.6% in 2018 (n = 427; 95% CI, 16.1%-19.1%), an increase of 1,850% (P less than .001). The rate of methamphetamine-positive tests that also were positive for nonprescribed fentanyl also started at 0.9% in 2013 (n = 29; 95% CI, 0.6%-1.2%) but rose to 7.9% in 2018 (n = 344; 95% CI, 7.1%-8.7%, a 798% increase (P less than .001). The study was published in JAMA Network Open.

The investigators suggested two explanations for these increases: intentional combination of drugs for “speedball effects” of combining stimulants and depressants and/or unintentional exposure on the part of users through contamination of substances. There have been increases in both cocaine-related and methamphetamine-related deaths, and the investigators of this study suspect these increases could be explained in part by overlap with opioids such as fentanyl. Part of the overdose risk inherent in these combinations is that, as the stimulant wears off, the fentanyl increasingly depresses the respiratory system, according to investigators; alternatively, opioid-naive stimulant users might be exposed to high levels of fentanyl with no opioid tolerance, which also can lead to overdose.

The study’s limitations include how samples were submitted – by health care professionals as part of routine care – and the possibility that individuals’ list of prescribed medications could have been incomplete or inaccurate such that the presence of prescribed fentanyl was counted as nonprescribed.

“The combination of nonprescribed fentanyl with cocaine or methamphetamine places an individual at increased risk of overdose,” they concluded. “Clinicians treating these individuals, and the individuals themselves, should be aware of this risk. Additionally, efforts should be made to educate the public about this risk and about overdose prevention.”

cpalmer@mdedge.com

SOURCE: LaRue L et al. JAMA Netw Open. 2019 Apr 26. doi: 10.1001/jamanetworkopen.2019.2851.

Rates of a potentially deadly overlap between use of nonprescribed fentanyl and use of either cocaine or methamphetamine have been increasing, a cross-sectional study of 1 million urine drug tests shows.

Leah LaRue, PharmD, of Millennium Health in San Diego, and colleagues performed the study, which sampled 1 million urine drug tests submitted by health care professionals “as part of routine care” during Jan. 1, 2013–Sept. 30, 2018. They isolated tests that were positive for either cocaine or methamphetamine – but not positive for both – and then determined how many in each group were also positive for nonprescribed fentanyl. Their analyses showed that the rate of cocaine-positive tests that also were positive for nonprescribed fentanyl increased from 0.9% in 2013 (n = 84; 95% confidence interval, 0.7%-1.1%) to 17.6% in 2018 (n = 427; 95% CI, 16.1%-19.1%), an increase of 1,850% (P less than .001). The rate of methamphetamine-positive tests that also were positive for nonprescribed fentanyl also started at 0.9% in 2013 (n = 29; 95% CI, 0.6%-1.2%) but rose to 7.9% in 2018 (n = 344; 95% CI, 7.1%-8.7%, a 798% increase (P less than .001). The study was published in JAMA Network Open.

The investigators suggested two explanations for these increases: intentional combination of drugs for “speedball effects” of combining stimulants and depressants and/or unintentional exposure on the part of users through contamination of substances. There have been increases in both cocaine-related and methamphetamine-related deaths, and the investigators of this study suspect these increases could be explained in part by overlap with opioids such as fentanyl. Part of the overdose risk inherent in these combinations is that, as the stimulant wears off, the fentanyl increasingly depresses the respiratory system, according to investigators; alternatively, opioid-naive stimulant users might be exposed to high levels of fentanyl with no opioid tolerance, which also can lead to overdose.

The study’s limitations include how samples were submitted – by health care professionals as part of routine care – and the possibility that individuals’ list of prescribed medications could have been incomplete or inaccurate such that the presence of prescribed fentanyl was counted as nonprescribed.

“The combination of nonprescribed fentanyl with cocaine or methamphetamine places an individual at increased risk of overdose,” they concluded. “Clinicians treating these individuals, and the individuals themselves, should be aware of this risk. Additionally, efforts should be made to educate the public about this risk and about overdose prevention.”

cpalmer@mdedge.com

SOURCE: LaRue L et al. JAMA Netw Open. 2019 Apr 26. doi: 10.1001/jamanetworkopen.2019.2851.

For patients with relapsed/refractory chronic lymphocytic leukemia (CLL), long-term treatment with the phosphoinositol 3-kinase inhibitor idelalisib appears safe and effective, according to investigators.

Final results from a phase 3 trial confirmed survival advantages when idelalisib is used in combination with rituximab, reported lead author Jeff P. Sharman, MD, of Willamette Valley Cancer Institute and Research Center in Springfield, Ore., and colleagues.

During follow-up, which exceeded 5 years in some patients, no new idelalisib-related adverse events were encountered, supporting the safety of long-term use, the investigators noted. The report is in the Journal of Clinical Oncology.

This study was “pivotal” for treating elderly patients with relapsed CLL, the investigators wrote, as these patients previously had few treatment options beyond supportive or palliative care.

Earlier results from the study showed that adding idelalisib to rituximab raised overall response rates from about 15.5% to 83.6% and median progression-free survival from 6.5 months to 19.4 months, resulting in “significantly better clinical outcomes compared with those seen with rituximab alone,” leading to approval by the Food and Drug Administration.

During the primary study, 110 patients received a combination of idelalisib and rituximab, while 108 patients received rituximab and placebo. The median patient age was 71 years, with a median of three lines of prior therapy. The present analysis focused on the 110 patients in the combination group who received at least one dose of idelalisib, whether or not they elected to participate in the extension phase.

After a median follow-up of 18 months, ranging from 0.3 months to 67.6 months, the overall response rate was 85.5% and the median progression-free survival was 20.3 months, both of which are similar to earlier findings. Median overall survival was 40.6 months.

With a median duration of exposure of 16.2 months, the safety analysis revealed no new idelalisib-related adverse events.

However, the investigators pointed out that prolonged therapy often led to diarrhea, which ultimately occurred in about half of patients (46.4%). Roughly equal amounts of patients experienced grade 2 (17.3%) or grade 3 or greater diarrhea (16.4%). In cases of grade 3 or greater diarrhea, steroid therapy was recommended, typically resulting in symptom resolution within 2 weeks; however, “there were insufficient numbers of patients to determine if steroid therapy affected the duration of symptoms,” the investigators wrote.

“The longer-term data presented here confirm the previously reported efficacy of targeting PI3K with idelalisib in patients with relapsed/refractory CLL and support the use of [idelalisib and rituximab] in this patient population with careful management of potential [adverse events],” they wrote.

Gilead Sciences funded the study. Dr. Sharman reported financial relationships with Gilead and other companies.

SOURCE: Sharman JP et al. J Clin Oncol. 2019 Apr 17. doi: 10.1200/JCO.18.01460.

For patients with relapsed/refractory chronic lymphocytic leukemia (CLL), long-term treatment with the phosphoinositol 3-kinase inhibitor idelalisib appears safe and effective, according to investigators.

Final results from a phase 3 trial confirmed survival advantages when idelalisib is used in combination with rituximab, reported lead author Jeff P. Sharman, MD, of Willamette Valley Cancer Institute and Research Center in Springfield, Ore., and colleagues.

During follow-up, which exceeded 5 years in some patients, no new idelalisib-related adverse events were encountered, supporting the safety of long-term use, the investigators noted. The report is in the Journal of Clinical Oncology.

This study was “pivotal” for treating elderly patients with relapsed CLL, the investigators wrote, as these patients previously had few treatment options beyond supportive or palliative care.

Earlier results from the study showed that adding idelalisib to rituximab raised overall response rates from about 15.5% to 83.6% and median progression-free survival from 6.5 months to 19.4 months, resulting in “significantly better clinical outcomes compared with those seen with rituximab alone,” leading to approval by the Food and Drug Administration.

During the primary study, 110 patients received a combination of idelalisib and rituximab, while 108 patients received rituximab and placebo. The median patient age was 71 years, with a median of three lines of prior therapy. The present analysis focused on the 110 patients in the combination group who received at least one dose of idelalisib, whether or not they elected to participate in the extension phase.

After a median follow-up of 18 months, ranging from 0.3 months to 67.6 months, the overall response rate was 85.5% and the median progression-free survival was 20.3 months, both of which are similar to earlier findings. Median overall survival was 40.6 months.

With a median duration of exposure of 16.2 months, the safety analysis revealed no new idelalisib-related adverse events.

However, the investigators pointed out that prolonged therapy often led to diarrhea, which ultimately occurred in about half of patients (46.4%). Roughly equal amounts of patients experienced grade 2 (17.3%) or grade 3 or greater diarrhea (16.4%). In cases of grade 3 or greater diarrhea, steroid therapy was recommended, typically resulting in symptom resolution within 2 weeks; however, “there were insufficient numbers of patients to determine if steroid therapy affected the duration of symptoms,” the investigators wrote.

“The longer-term data presented here confirm the previously reported efficacy of targeting PI3K with idelalisib in patients with relapsed/refractory CLL and support the use of [idelalisib and rituximab] in this patient population with careful management of potential [adverse events],” they wrote.

Gilead Sciences funded the study. Dr. Sharman reported financial relationships with Gilead and other companies.

SOURCE: Sharman JP et al. J Clin Oncol. 2019 Apr 17. doi: 10.1200/JCO.18.01460.

For patients with relapsed/refractory chronic lymphocytic leukemia (CLL), long-term treatment with the phosphoinositol 3-kinase inhibitor idelalisib appears safe and effective, according to investigators.

Final results from a phase 3 trial confirmed survival advantages when idelalisib is used in combination with rituximab, reported lead author Jeff P. Sharman, MD, of Willamette Valley Cancer Institute and Research Center in Springfield, Ore., and colleagues.

During follow-up, which exceeded 5 years in some patients, no new idelalisib-related adverse events were encountered, supporting the safety of long-term use, the investigators noted. The report is in the Journal of Clinical Oncology.

This study was “pivotal” for treating elderly patients with relapsed CLL, the investigators wrote, as these patients previously had few treatment options beyond supportive or palliative care.

Earlier results from the study showed that adding idelalisib to rituximab raised overall response rates from about 15.5% to 83.6% and median progression-free survival from 6.5 months to 19.4 months, resulting in “significantly better clinical outcomes compared with those seen with rituximab alone,” leading to approval by the Food and Drug Administration.

During the primary study, 110 patients received a combination of idelalisib and rituximab, while 108 patients received rituximab and placebo. The median patient age was 71 years, with a median of three lines of prior therapy. The present analysis focused on the 110 patients in the combination group who received at least one dose of idelalisib, whether or not they elected to participate in the extension phase.

After a median follow-up of 18 months, ranging from 0.3 months to 67.6 months, the overall response rate was 85.5% and the median progression-free survival was 20.3 months, both of which are similar to earlier findings. Median overall survival was 40.6 months.

With a median duration of exposure of 16.2 months, the safety analysis revealed no new idelalisib-related adverse events.

However, the investigators pointed out that prolonged therapy often led to diarrhea, which ultimately occurred in about half of patients (46.4%). Roughly equal amounts of patients experienced grade 2 (17.3%) or grade 3 or greater diarrhea (16.4%). In cases of grade 3 or greater diarrhea, steroid therapy was recommended, typically resulting in symptom resolution within 2 weeks; however, “there were insufficient numbers of patients to determine if steroid therapy affected the duration of symptoms,” the investigators wrote.

“The longer-term data presented here confirm the previously reported efficacy of targeting PI3K with idelalisib in patients with relapsed/refractory CLL and support the use of [idelalisib and rituximab] in this patient population with careful management of potential [adverse events],” they wrote.

Gilead Sciences funded the study. Dr. Sharman reported financial relationships with Gilead and other companies.

SOURCE: Sharman JP et al. J Clin Oncol. 2019 Apr 17. doi: 10.1200/JCO.18.01460.

Although nutrition therapy is pivotal in the management of patients with diabetes or prediabetes, there’s no one correct eating pattern appropriate for all patients, according to a consensus report from an expert panel convened by the American Diabetes Association.

A one-size-fits-all eating plan would be an unrealistic expectation, given the diversity of cultural issues, personal preferences, comorbidities, and other factors that are unique to individual patients with diabetes or prediabetes, according to the report, which was published in Diabetes Care.

Instead, authors of the report outlined nine different eating patterns, along with the evidence supporting their use and their reported benefits in patients with diabetes or prediabetes.

The report reflects a commitment to developing evidence-based guidelines that are “achievable and meet people where they are” to formulate individualized nutrition plans, William T. Cefalu, MD, chief scientific, medical, and mission officer for the ADA, said in a statement.

“The importance of this consensus also lies in the fact it was authored by a group of experts who are extremely knowledgeable about numerous eating patterns, including vegan, vegetarian, and low carb,” Dr. Cefalu added.

The expert panel of 14 individuals included registered dietitians, diabetes educators, endocrinologists, a primary care physician, and a patient advocate who all answered a national call for experts, according to the ADA.

The panel reviewed more than 600 nutrition manuscripts published between 2014 and 2018 to develop the new consensus statement, which updates the ADA 2014 position statement on nutrition therapy for adults with diabetes and has been incorporated into the association’s Standards of Medical Care in Diabetes–2019 supplement as a living standards update.

All adults with type 1 or 2 diabetes should be referred to individualized, diabetes-focused medical nutrition therapy, the panel members wrote in their report.

There is no evidence suggesting an ideal percentage of calories from carbohydrate, protein, and fat in patients with prediabetes or diabetes, so macronutrient distribution should also be individualized, according to the panel.

Likewise, a variety of eating patterns are acceptable for managing diabetes, according to the report, which describes evidence for eating patterns including Mediterranean, vegetarian or vegan, low fat and very low fat, low carbohydrate and very low carbohydrate, and paleo, as well as the Dietary Approaches to Stop Hypertension diet and the Department of Agriculture Dietary Guidelines for Americans.

Not all diets have the same level of evidence, however. For prevention of prediabetes or type 2 diabetes, for example, the most robust research is available for Mediterranean-style, low-fat, and low-carbohydrate eating patterns, the panel said.

Until there’s better comparative evidence between eating patterns, health care providers should concentrate on several key factors common to a number of the eating patterns, such as limiting sugars and refined grains, emphasizing nonstarchy vegetables, and choosing whole foods over processed foods, the experts wrote.

Consensus panel participants reported disclosures with the ADA, the National Institutes of Health, the Academy of Nutrition and Dietetics, the American Medical Group Association, the University of Michigan, Novo Nordisk, Merck, Amgen, Gilead, BOYDSense, Janssen, Sanofi, Pfizer, Sunstar Foundation, New England Dairy and Dairy Farmer, the National Dairy Council, Kowa Company, and dietdoctor.com.

SOURCE: Evert AB et al. Diabetes Care. 2019 Apr 18. doi: 10.2337/dci19-0014.

Although nutrition therapy is pivotal in the management of patients with diabetes or prediabetes, there’s no one correct eating pattern appropriate for all patients, according to a consensus report from an expert panel convened by the American Diabetes Association.

A one-size-fits-all eating plan would be an unrealistic expectation, given the diversity of cultural issues, personal preferences, comorbidities, and other factors that are unique to individual patients with diabetes or prediabetes, according to the report, which was published in Diabetes Care.

Instead, authors of the report outlined nine different eating patterns, along with the evidence supporting their use and their reported benefits in patients with diabetes or prediabetes.

The report reflects a commitment to developing evidence-based guidelines that are “achievable and meet people where they are” to formulate individualized nutrition plans, William T. Cefalu, MD, chief scientific, medical, and mission officer for the ADA, said in a statement.

“The importance of this consensus also lies in the fact it was authored by a group of experts who are extremely knowledgeable about numerous eating patterns, including vegan, vegetarian, and low carb,” Dr. Cefalu added.

The expert panel of 14 individuals included registered dietitians, diabetes educators, endocrinologists, a primary care physician, and a patient advocate who all answered a national call for experts, according to the ADA.

The panel reviewed more than 600 nutrition manuscripts published between 2014 and 2018 to develop the new consensus statement, which updates the ADA 2014 position statement on nutrition therapy for adults with diabetes and has been incorporated into the association’s Standards of Medical Care in Diabetes–2019 supplement as a living standards update.

All adults with type 1 or 2 diabetes should be referred to individualized, diabetes-focused medical nutrition therapy, the panel members wrote in their report.

There is no evidence suggesting an ideal percentage of calories from carbohydrate, protein, and fat in patients with prediabetes or diabetes, so macronutrient distribution should also be individualized, according to the panel.

Likewise, a variety of eating patterns are acceptable for managing diabetes, according to the report, which describes evidence for eating patterns including Mediterranean, vegetarian or vegan, low fat and very low fat, low carbohydrate and very low carbohydrate, and paleo, as well as the Dietary Approaches to Stop Hypertension diet and the Department of Agriculture Dietary Guidelines for Americans.

Not all diets have the same level of evidence, however. For prevention of prediabetes or type 2 diabetes, for example, the most robust research is available for Mediterranean-style, low-fat, and low-carbohydrate eating patterns, the panel said.

Until there’s better comparative evidence between eating patterns, health care providers should concentrate on several key factors common to a number of the eating patterns, such as limiting sugars and refined grains, emphasizing nonstarchy vegetables, and choosing whole foods over processed foods, the experts wrote.

Consensus panel participants reported disclosures with the ADA, the National Institutes of Health, the Academy of Nutrition and Dietetics, the American Medical Group Association, the University of Michigan, Novo Nordisk, Merck, Amgen, Gilead, BOYDSense, Janssen, Sanofi, Pfizer, Sunstar Foundation, New England Dairy and Dairy Farmer, the National Dairy Council, Kowa Company, and dietdoctor.com.

SOURCE: Evert AB et al. Diabetes Care. 2019 Apr 18. doi: 10.2337/dci19-0014.

Although nutrition therapy is pivotal in the management of patients with diabetes or prediabetes, there’s no one correct eating pattern appropriate for all patients, according to a consensus report from an expert panel convened by the American Diabetes Association.

A one-size-fits-all eating plan would be an unrealistic expectation, given the diversity of cultural issues, personal preferences, comorbidities, and other factors that are unique to individual patients with diabetes or prediabetes, according to the report, which was published in Diabetes Care.

Instead, authors of the report outlined nine different eating patterns, along with the evidence supporting their use and their reported benefits in patients with diabetes or prediabetes.

The report reflects a commitment to developing evidence-based guidelines that are “achievable and meet people where they are” to formulate individualized nutrition plans, William T. Cefalu, MD, chief scientific, medical, and mission officer for the ADA, said in a statement.

“The importance of this consensus also lies in the fact it was authored by a group of experts who are extremely knowledgeable about numerous eating patterns, including vegan, vegetarian, and low carb,” Dr. Cefalu added.

The expert panel of 14 individuals included registered dietitians, diabetes educators, endocrinologists, a primary care physician, and a patient advocate who all answered a national call for experts, according to the ADA.

The panel reviewed more than 600 nutrition manuscripts published between 2014 and 2018 to develop the new consensus statement, which updates the ADA 2014 position statement on nutrition therapy for adults with diabetes and has been incorporated into the association’s Standards of Medical Care in Diabetes–2019 supplement as a living standards update.

All adults with type 1 or 2 diabetes should be referred to individualized, diabetes-focused medical nutrition therapy, the panel members wrote in their report.

There is no evidence suggesting an ideal percentage of calories from carbohydrate, protein, and fat in patients with prediabetes or diabetes, so macronutrient distribution should also be individualized, according to the panel.

Likewise, a variety of eating patterns are acceptable for managing diabetes, according to the report, which describes evidence for eating patterns including Mediterranean, vegetarian or vegan, low fat and very low fat, low carbohydrate and very low carbohydrate, and paleo, as well as the Dietary Approaches to Stop Hypertension diet and the Department of Agriculture Dietary Guidelines for Americans.

Not all diets have the same level of evidence, however. For prevention of prediabetes or type 2 diabetes, for example, the most robust research is available for Mediterranean-style, low-fat, and low-carbohydrate eating patterns, the panel said.

Until there’s better comparative evidence between eating patterns, health care providers should concentrate on several key factors common to a number of the eating patterns, such as limiting sugars and refined grains, emphasizing nonstarchy vegetables, and choosing whole foods over processed foods, the experts wrote.

Consensus panel participants reported disclosures with the ADA, the National Institutes of Health, the Academy of Nutrition and Dietetics, the American Medical Group Association, the University of Michigan, Novo Nordisk, Merck, Amgen, Gilead, BOYDSense, Janssen, Sanofi, Pfizer, Sunstar Foundation, New England Dairy and Dairy Farmer, the National Dairy Council, Kowa Company, and dietdoctor.com.

SOURCE: Evert AB et al. Diabetes Care. 2019 Apr 18. doi: 10.2337/dci19-0014.

The Food and Drug Administration has approved a topical combination of corticosteroid halobetasol propionate (0.01%) and the topical retinoid, tazarotene (0.045%), in a lotion formulation, for the treatment of plaque psoriasis in adults, the manufacturer announced on April 25.

A press release from the manufacturer, Ortho Dermatologics, summarized the results of two phase 3 studies that compared treatment with the combination product, in 418 adults with moderate to severe plaque psoriasis. At week 8, the proportion of patients who had achieved treatment success – defined as at least a two-grade improvement in Investigator Global Assessment score and a score of “clear” or “almost clear” – was 36% and 45% in the treatment groups, compared with 7% and 13% of those on vehicle, respectively (P less than .001 for both).

The release also refers to a phase 2 study of 212 patients, which found that the combination treatment was more effective in treating plaque psoriasis than was either component separately (J Drugs Dermatol. 2017 Mar 1;16[1]:197-204). By week 8, 52.5% of patients treated with the combination lotion had shown treatment success – compared with 33.3% of those treated with halobetasol, 18.6% of those treated with tazarotene, and 9.7% of those treated with vehicle (P = .033).

Common treatment-related adverse events included treatment site reactions, such as irritation, pain, itching, and folliculitis. Treatment may cause birth defects if used during pregnancy, so a negative pregnancy test should be obtained before treatment begins and effective birth control should be used during treatment.

It will be marketed under the trade name Duobrii and is priced at $825 for a 100-gram tube, according to the press release.

cpalmer@mdedge.com

The Food and Drug Administration has approved a topical combination of corticosteroid halobetasol propionate (0.01%) and the topical retinoid, tazarotene (0.045%), in a lotion formulation, for the treatment of plaque psoriasis in adults, the manufacturer announced on April 25.

A press release from the manufacturer, Ortho Dermatologics, summarized the results of two phase 3 studies that compared treatment with the combination product, in 418 adults with moderate to severe plaque psoriasis. At week 8, the proportion of patients who had achieved treatment success – defined as at least a two-grade improvement in Investigator Global Assessment score and a score of “clear” or “almost clear” – was 36% and 45% in the treatment groups, compared with 7% and 13% of those on vehicle, respectively (P less than .001 for both).

The release also refers to a phase 2 study of 212 patients, which found that the combination treatment was more effective in treating plaque psoriasis than was either component separately (J Drugs Dermatol. 2017 Mar 1;16[1]:197-204). By week 8, 52.5% of patients treated with the combination lotion had shown treatment success – compared with 33.3% of those treated with halobetasol, 18.6% of those treated with tazarotene, and 9.7% of those treated with vehicle (P = .033).

Common treatment-related adverse events included treatment site reactions, such as irritation, pain, itching, and folliculitis. Treatment may cause birth defects if used during pregnancy, so a negative pregnancy test should be obtained before treatment begins and effective birth control should be used during treatment.

It will be marketed under the trade name Duobrii and is priced at $825 for a 100-gram tube, according to the press release.

cpalmer@mdedge.com

The Food and Drug Administration has approved a topical combination of corticosteroid halobetasol propionate (0.01%) and the topical retinoid, tazarotene (0.045%), in a lotion formulation, for the treatment of plaque psoriasis in adults, the manufacturer announced on April 25.

A press release from the manufacturer, Ortho Dermatologics, summarized the results of two phase 3 studies that compared treatment with the combination product, in 418 adults with moderate to severe plaque psoriasis. At week 8, the proportion of patients who had achieved treatment success – defined as at least a two-grade improvement in Investigator Global Assessment score and a score of “clear” or “almost clear” – was 36% and 45% in the treatment groups, compared with 7% and 13% of those on vehicle, respectively (P less than .001 for both).

The release also refers to a phase 2 study of 212 patients, which found that the combination treatment was more effective in treating plaque psoriasis than was either component separately (J Drugs Dermatol. 2017 Mar 1;16[1]:197-204). By week 8, 52.5% of patients treated with the combination lotion had shown treatment success – compared with 33.3% of those treated with halobetasol, 18.6% of those treated with tazarotene, and 9.7% of those treated with vehicle (P = .033).

Common treatment-related adverse events included treatment site reactions, such as irritation, pain, itching, and folliculitis. Treatment may cause birth defects if used during pregnancy, so a negative pregnancy test should be obtained before treatment begins and effective birth control should be used during treatment.

It will be marketed under the trade name Duobrii and is priced at $825 for a 100-gram tube, according to the press release.

cpalmer@mdedge.com

Losing a patient to suicide is one of the most difficult and painful experiences a psychiatrist will face. In addition to concern for the patient and his or her family, psychiatrists may experience thoughts of responsibility and what they could have done to prevent the suicide. Although often trained in helping patients address grief, psychiatrists may not be as comfortable processing their own grief after the loss of a patient to suicide.

On April 24, MDedge Psychiatry hosted a conversation on Twitter to help psychiatrists examine some of their own feelings about losing patients in this way. Two psychiatrists – Dinah Miller, MD, and Eric Plakun, MD – responded to questions on this topic.

Dr. Miller is the author of numerous books and articles, including “Committed: The Battle Over Involuntary Care” (Baltimore: Johns Hopkins University Press, 2016), which she wrote with Dr. Annette Hanson, and a piece in the New England Journal of Medicine about her own experience with the death of a patient to suicide. She has a private practice in Baltimore and is affiliated with Johns Hopkins University there. Dr. Plakun is the medical director and CEO of the Austen Riggs Center based in Stockbridge, Mass., a “Top 10” U.S. News and World Report “Best Hospital” in psychiatry. He also serves on the board of trustees of the American Psychiatric Association representing New England and Eastern Canada, and was the founding leader of the APA Psychotherapy Caucus. Dr. Plakun is a board-certified psychiatrist, psychoanalyst, former member of the Harvard Medical School clinical faculty, and author of more than 50 publications.

Some of the conversation focused on the impact of patient suicide on young doctors. “I tell the residents: Never Worry Alone,” Dr. Miller wrote. “When in doubt, get supervision, curbside consult, formal paid supervision, or send the patient for a second opinion. Have friends.”

Dr. Miller also wrote that these kinds of losses are difficult for experienced doctors, but “just awful when you’re just starting out. A young psychiatrist I knew lost two patients early on in her career. Hang in there – sending support.”

“The impact on trainees is often major and enduring,” Dr. Plakun wrote. “Questioning whether one wants to do such work is not unusual.”

The following is an edited version of the discussion.
 

Question: Have you ever lost a patient to suicide?

Dr. Plakun: This is an important subject and worth bringing to wider discussion. Thirty-eight percent of clinicians experience a significant reaction to this kind of loss.

Dr. Miller: I spent decades worrying that a patient might die by suicide. The reality was more troubling to me than I imagined. It left me more hesitant, less trusting of both the patients and myself. Not always, just at moments. The work we do is hard.

Dr. Plakun: Not one I was working with, but several after we terminated. And it has happened to patients I admitted to Austen Riggs during 35 years as director of admissions.

Dr. Miller: You know, I was struck by the fact that we have no formal way to approach this ... the APA info is for residents. This was part of why I wrote the NEJM piece, to open the conversation.
 

Question: How do you think the loss of your patient changed your approach to psychiatry?

Dr. Miller: One of the things I’ve heard is that recovering from this tremendous loss helps doctors/therapists to know that others have had a rough time, and that this isn’t weird or odd, and that they are not alone.

Question: How did the loss change you?

Dr. Miller: I did not feel a sense of “blame.” I imagine that would have made it much more difficult. An internist wrote to me discussing how he’d dismissed a patient’s chest pain and the patient died – there are so many layers of complexity here. So many different stories.

Dr. Plakun: I think the impact on us is great because in suicide the deceased is both victim and perpetrator of murder, while we have tried to empathize with both sides.

Dr. Miller: I imagine everyone feels some distress, some emotional response. It’s hard to imagine that a doctor or therapist would hear a patient under their care died of any cause and would feel nothing.

Closing observations

Dr. Plakun: If you lose a patient to suicide, seek consultation and support from a trusted colleague. Remember that isolation will be part of the problem, not the solution. Remember to call your insurance carrier for consultation regarding risk-management issues.

Dr. Miller: I think this topic is difficult for docs/therapists to listen to. It’s hard to sit with a friend/colleague’s pain.

Dr. Plakun: Meeting with family is an issue. The primary purpose of such meetings is to meet their needs – not your own. Help them deal with a traumatic loss causing powerful and complicated feelings. If it helps you, that’s a bonus rather than the goal of the meeting.

References

Miller D. When a patient dies by suicide –The physician’s silent sorrow. (N Engl J Med. 2019 Jan 24;380:311-3).

Plakun EM. Psychotherapy with suicidal patients, Part 1: Expert consensus recommendations. (J Psychiatr Prac. 2018 Nov;249[6]:420-3).

Plakun EM and Jane G. Tillman. Responding to clinicians after loss of a patient to suicide. Directions in Psychiatry. 2005 Oct.

Connect with Dr. Miller on Twitter at @shrinkrapdinah and with Dr. Plakun at @EricPlakunMD. And look for #MDedgeChats to find the complete conversation on Twitter. Dr. Miller and Dr. Plakun will be joining Lorenzo Norris, MD, and Jane Tillman, PhD, for a discussion of this topic from noon to 1 p.m. on Monday, May 20, at the American Psychiatric Association annual meeting in San Francisco for a live recording of the MDedge Psychcast. Join them at booth 1518!

Also, as in past years, Dr. Plakun will join Dr. Tillman to offer a workshop at the APA meeting called “Responding to the Impact of Suicide on Clinicians.” The workshop (session ID: 1054) will be held on Sunday, May 19, 10 a.m. – 11:30 a.m., in Room 153, upper mezzanine, Moscone South.
 

Losing a patient to suicide is one of the most difficult and painful experiences a psychiatrist will face. In addition to concern for the patient and his or her family, psychiatrists may experience thoughts of responsibility and what they could have done to prevent the suicide. Although often trained in helping patients address grief, psychiatrists may not be as comfortable processing their own grief after the loss of a patient to suicide.

On April 24, MDedge Psychiatry hosted a conversation on Twitter to help psychiatrists examine some of their own feelings about losing patients in this way. Two psychiatrists – Dinah Miller, MD, and Eric Plakun, MD – responded to questions on this topic.

Dr. Miller is the author of numerous books and articles, including “Committed: The Battle Over Involuntary Care” (Baltimore: Johns Hopkins University Press, 2016), which she wrote with Dr. Annette Hanson, and a piece in the New England Journal of Medicine about her own experience with the death of a patient to suicide. She has a private practice in Baltimore and is affiliated with Johns Hopkins University there. Dr. Plakun is the medical director and CEO of the Austen Riggs Center based in Stockbridge, Mass., a “Top 10” U.S. News and World Report “Best Hospital” in psychiatry. He also serves on the board of trustees of the American Psychiatric Association representing New England and Eastern Canada, and was the founding leader of the APA Psychotherapy Caucus. Dr. Plakun is a board-certified psychiatrist, psychoanalyst, former member of the Harvard Medical School clinical faculty, and author of more than 50 publications.

Some of the conversation focused on the impact of patient suicide on young doctors. “I tell the residents: Never Worry Alone,” Dr. Miller wrote. “When in doubt, get supervision, curbside consult, formal paid supervision, or send the patient for a second opinion. Have friends.”

Dr. Miller also wrote that these kinds of losses are difficult for experienced doctors, but “just awful when you’re just starting out. A young psychiatrist I knew lost two patients early on in her career. Hang in there – sending support.”

“The impact on trainees is often major and enduring,” Dr. Plakun wrote. “Questioning whether one wants to do such work is not unusual.”

The following is an edited version of the discussion.
 

Question: Have you ever lost a patient to suicide?

Dr. Plakun: This is an important subject and worth bringing to wider discussion. Thirty-eight percent of clinicians experience a significant reaction to this kind of loss.

Dr. Miller: I spent decades worrying that a patient might die by suicide. The reality was more troubling to me than I imagined. It left me more hesitant, less trusting of both the patients and myself. Not always, just at moments. The work we do is hard.

Dr. Plakun: Not one I was working with, but several after we terminated. And it has happened to patients I admitted to Austen Riggs during 35 years as director of admissions.

Dr. Miller: You know, I was struck by the fact that we have no formal way to approach this ... the APA info is for residents. This was part of why I wrote the NEJM piece, to open the conversation.
 

Question: How do you think the loss of your patient changed your approach to psychiatry?

Dr. Miller: One of the things I’ve heard is that recovering from this tremendous loss helps doctors/therapists to know that others have had a rough time, and that this isn’t weird or odd, and that they are not alone.

Question: How did the loss change you?

Dr. Miller: I did not feel a sense of “blame.” I imagine that would have made it much more difficult. An internist wrote to me discussing how he’d dismissed a patient’s chest pain and the patient died – there are so many layers of complexity here. So many different stories.

Dr. Plakun: I think the impact on us is great because in suicide the deceased is both victim and perpetrator of murder, while we have tried to empathize with both sides.

Dr. Miller: I imagine everyone feels some distress, some emotional response. It’s hard to imagine that a doctor or therapist would hear a patient under their care died of any cause and would feel nothing.

Closing observations

Dr. Plakun: If you lose a patient to suicide, seek consultation and support from a trusted colleague. Remember that isolation will be part of the problem, not the solution. Remember to call your insurance carrier for consultation regarding risk-management issues.

Dr. Miller: I think this topic is difficult for docs/therapists to listen to. It’s hard to sit with a friend/colleague’s pain.

Dr. Plakun: Meeting with family is an issue. The primary purpose of such meetings is to meet their needs – not your own. Help them deal with a traumatic loss causing powerful and complicated feelings. If it helps you, that’s a bonus rather than the goal of the meeting.

References

Miller D. When a patient dies by suicide –The physician’s silent sorrow. (N Engl J Med. 2019 Jan 24;380:311-3).

Plakun EM. Psychotherapy with suicidal patients, Part 1: Expert consensus recommendations. (J Psychiatr Prac. 2018 Nov;249[6]:420-3).

Plakun EM and Jane G. Tillman. Responding to clinicians after loss of a patient to suicide. Directions in Psychiatry. 2005 Oct.

Connect with Dr. Miller on Twitter at @shrinkrapdinah and with Dr. Plakun at @EricPlakunMD. And look for #MDedgeChats to find the complete conversation on Twitter. Dr. Miller and Dr. Plakun will be joining Lorenzo Norris, MD, and Jane Tillman, PhD, for a discussion of this topic from noon to 1 p.m. on Monday, May 20, at the American Psychiatric Association annual meeting in San Francisco for a live recording of the MDedge Psychcast. Join them at booth 1518!

Also, as in past years, Dr. Plakun will join Dr. Tillman to offer a workshop at the APA meeting called “Responding to the Impact of Suicide on Clinicians.” The workshop (session ID: 1054) will be held on Sunday, May 19, 10 a.m. – 11:30 a.m., in Room 153, upper mezzanine, Moscone South.
 

Losing a patient to suicide is one of the most difficult and painful experiences a psychiatrist will face. In addition to concern for the patient and his or her family, psychiatrists may experience thoughts of responsibility and what they could have done to prevent the suicide. Although often trained in helping patients address grief, psychiatrists may not be as comfortable processing their own grief after the loss of a patient to suicide.

On April 24, MDedge Psychiatry hosted a conversation on Twitter to help psychiatrists examine some of their own feelings about losing patients in this way. Two psychiatrists – Dinah Miller, MD, and Eric Plakun, MD – responded to questions on this topic.

Dr. Miller is the author of numerous books and articles, including “Committed: The Battle Over Involuntary Care” (Baltimore: Johns Hopkins University Press, 2016), which she wrote with Dr. Annette Hanson, and a piece in the New England Journal of Medicine about her own experience with the death of a patient to suicide. She has a private practice in Baltimore and is affiliated with Johns Hopkins University there. Dr. Plakun is the medical director and CEO of the Austen Riggs Center based in Stockbridge, Mass., a “Top 10” U.S. News and World Report “Best Hospital” in psychiatry. He also serves on the board of trustees of the American Psychiatric Association representing New England and Eastern Canada, and was the founding leader of the APA Psychotherapy Caucus. Dr. Plakun is a board-certified psychiatrist, psychoanalyst, former member of the Harvard Medical School clinical faculty, and author of more than 50 publications.

Some of the conversation focused on the impact of patient suicide on young doctors. “I tell the residents: Never Worry Alone,” Dr. Miller wrote. “When in doubt, get supervision, curbside consult, formal paid supervision, or send the patient for a second opinion. Have friends.”

Dr. Miller also wrote that these kinds of losses are difficult for experienced doctors, but “just awful when you’re just starting out. A young psychiatrist I knew lost two patients early on in her career. Hang in there – sending support.”

“The impact on trainees is often major and enduring,” Dr. Plakun wrote. “Questioning whether one wants to do such work is not unusual.”

The following is an edited version of the discussion.
 

Question: Have you ever lost a patient to suicide?

Dr. Plakun: This is an important subject and worth bringing to wider discussion. Thirty-eight percent of clinicians experience a significant reaction to this kind of loss.

Dr. Miller: I spent decades worrying that a patient might die by suicide. The reality was more troubling to me than I imagined. It left me more hesitant, less trusting of both the patients and myself. Not always, just at moments. The work we do is hard.

Dr. Plakun: Not one I was working with, but several after we terminated. And it has happened to patients I admitted to Austen Riggs during 35 years as director of admissions.

Dr. Miller: You know, I was struck by the fact that we have no formal way to approach this ... the APA info is for residents. This was part of why I wrote the NEJM piece, to open the conversation.
 

Question: How do you think the loss of your patient changed your approach to psychiatry?

Dr. Miller: One of the things I’ve heard is that recovering from this tremendous loss helps doctors/therapists to know that others have had a rough time, and that this isn’t weird or odd, and that they are not alone.

Question: How did the loss change you?

Dr. Miller: I did not feel a sense of “blame.” I imagine that would have made it much more difficult. An internist wrote to me discussing how he’d dismissed a patient’s chest pain and the patient died – there are so many layers of complexity here. So many different stories.

Dr. Plakun: I think the impact on us is great because in suicide the deceased is both victim and perpetrator of murder, while we have tried to empathize with both sides.

Dr. Miller: I imagine everyone feels some distress, some emotional response. It’s hard to imagine that a doctor or therapist would hear a patient under their care died of any cause and would feel nothing.

Closing observations

Dr. Plakun: If you lose a patient to suicide, seek consultation and support from a trusted colleague. Remember that isolation will be part of the problem, not the solution. Remember to call your insurance carrier for consultation regarding risk-management issues.

Dr. Miller: I think this topic is difficult for docs/therapists to listen to. It’s hard to sit with a friend/colleague’s pain.

Dr. Plakun: Meeting with family is an issue. The primary purpose of such meetings is to meet their needs – not your own. Help them deal with a traumatic loss causing powerful and complicated feelings. If it helps you, that’s a bonus rather than the goal of the meeting.

References

Miller D. When a patient dies by suicide –The physician’s silent sorrow. (N Engl J Med. 2019 Jan 24;380:311-3).

Plakun EM. Psychotherapy with suicidal patients, Part 1: Expert consensus recommendations. (J Psychiatr Prac. 2018 Nov;249[6]:420-3).

Plakun EM and Jane G. Tillman. Responding to clinicians after loss of a patient to suicide. Directions in Psychiatry. 2005 Oct.

Connect with Dr. Miller on Twitter at @shrinkrapdinah and with Dr. Plakun at @EricPlakunMD. And look for #MDedgeChats to find the complete conversation on Twitter. Dr. Miller and Dr. Plakun will be joining Lorenzo Norris, MD, and Jane Tillman, PhD, for a discussion of this topic from noon to 1 p.m. on Monday, May 20, at the American Psychiatric Association annual meeting in San Francisco for a live recording of the MDedge Psychcast. Join them at booth 1518!

Also, as in past years, Dr. Plakun will join Dr. Tillman to offer a workshop at the APA meeting called “Responding to the Impact of Suicide on Clinicians.” The workshop (session ID: 1054) will be held on Sunday, May 19, 10 a.m. – 11:30 a.m., in Room 153, upper mezzanine, Moscone South.
 

Although stroke is a risk factor for osteoporosis, falls, and fractures, very few people who have experienced a recent stroke are either screened for osteoporosis or treated, research suggests.

Writing in Stroke, researchers presented an analysis of Ontario registry data from 16,581 patients who were aged 65 years or older and presented with stroke between 2003 and 2013.

Overall, just 5.1% of patients underwent bone mineral density testing. Of the 1,577 patients who had experienced a prior fracture, 71 (4.7%) had bone mineral density testing, and only 2.9% of those who had not had prior bone mineral density testing were tested after their stroke. Bone mineral density testing was more likely in patients who were younger, who were female, and who experienced a low-trauma fracture in the year after their stroke.

In total, 15.5% of patients were prescribed osteoporosis drugs in the first year after their stroke. However, only 7.8% of those who had fractures before the stroke and 14.8% of those with fractures after the stroke received osteoporosis treatment after the stroke. Patients who were female, had prior osteoporosis, had experienced prior fracture, had previously undergone bone mineral density testing, or had experienced a fracture or fall after their stroke were more likely to receive osteoporosis pharmacotherapy.

The authors found that the neither the severity of stroke nor the presence of other comorbidities was associated with an increased likelihood of screening or treatment of osteoporosis after the stroke.

Stroke is associated with up to a fourfold increased risk of osteoporosis and fracture, compared with healthy controls, most probably because of reduced mobility and an increased risk of falls, wrote Eshita Kapoor of the department of medicine at the University of Toronto and her coauthors.

“Screening and treatment may be particularly low poststroke because of under-recognition of osteoporosis as a consequence of stroke, a selective focus on the management of cardiovascular risk and stroke recovery, or factors such as dysphagia precluding use of oral bisphosphonates,” the authors wrote.

While the association is noted in U.S. stroke guidelines, there are few recommendations for treatment aside from fall prevention strategies, which the authors noted was a missed opportunity for prevention.

“Use of a risk prediction score to identify those at particularly high short-term risk of fractures after stroke may help to prioritize patients for osteoporosis testing and treatment,” they suggested.

The study was funded by the Heart and Stroke Foundation of Canada and was supported by ICES (Institute for Clinical Evaluative Sciences) and the Ontario Ministry of Health and Long-Term Care. One author declared consultancies for the pharmaceutical sector. No other conflicts of interest were declared.

SOURCE: Kapoor E et al. Stroke. 2019 April 25. doi: 10.1161/STROKEAHA.118.024685
 

Although stroke is a risk factor for osteoporosis, falls, and fractures, very few people who have experienced a recent stroke are either screened for osteoporosis or treated, research suggests.

Writing in Stroke, researchers presented an analysis of Ontario registry data from 16,581 patients who were aged 65 years or older and presented with stroke between 2003 and 2013.

Overall, just 5.1% of patients underwent bone mineral density testing. Of the 1,577 patients who had experienced a prior fracture, 71 (4.7%) had bone mineral density testing, and only 2.9% of those who had not had prior bone mineral density testing were tested after their stroke. Bone mineral density testing was more likely in patients who were younger, who were female, and who experienced a low-trauma fracture in the year after their stroke.

In total, 15.5% of patients were prescribed osteoporosis drugs in the first year after their stroke. However, only 7.8% of those who had fractures before the stroke and 14.8% of those with fractures after the stroke received osteoporosis treatment after the stroke. Patients who were female, had prior osteoporosis, had experienced prior fracture, had previously undergone bone mineral density testing, or had experienced a fracture or fall after their stroke were more likely to receive osteoporosis pharmacotherapy.

The authors found that the neither the severity of stroke nor the presence of other comorbidities was associated with an increased likelihood of screening or treatment of osteoporosis after the stroke.

Stroke is associated with up to a fourfold increased risk of osteoporosis and fracture, compared with healthy controls, most probably because of reduced mobility and an increased risk of falls, wrote Eshita Kapoor of the department of medicine at the University of Toronto and her coauthors.

“Screening and treatment may be particularly low poststroke because of under-recognition of osteoporosis as a consequence of stroke, a selective focus on the management of cardiovascular risk and stroke recovery, or factors such as dysphagia precluding use of oral bisphosphonates,” the authors wrote.

While the association is noted in U.S. stroke guidelines, there are few recommendations for treatment aside from fall prevention strategies, which the authors noted was a missed opportunity for prevention.

“Use of a risk prediction score to identify those at particularly high short-term risk of fractures after stroke may help to prioritize patients for osteoporosis testing and treatment,” they suggested.

The study was funded by the Heart and Stroke Foundation of Canada and was supported by ICES (Institute for Clinical Evaluative Sciences) and the Ontario Ministry of Health and Long-Term Care. One author declared consultancies for the pharmaceutical sector. No other conflicts of interest were declared.

SOURCE: Kapoor E et al. Stroke. 2019 April 25. doi: 10.1161/STROKEAHA.118.024685
 

Although stroke is a risk factor for osteoporosis, falls, and fractures, very few people who have experienced a recent stroke are either screened for osteoporosis or treated, research suggests.

Writing in Stroke, researchers presented an analysis of Ontario registry data from 16,581 patients who were aged 65 years or older and presented with stroke between 2003 and 2013.

Overall, just 5.1% of patients underwent bone mineral density testing. Of the 1,577 patients who had experienced a prior fracture, 71 (4.7%) had bone mineral density testing, and only 2.9% of those who had not had prior bone mineral density testing were tested after their stroke. Bone mineral density testing was more likely in patients who were younger, who were female, and who experienced a low-trauma fracture in the year after their stroke.

In total, 15.5% of patients were prescribed osteoporosis drugs in the first year after their stroke. However, only 7.8% of those who had fractures before the stroke and 14.8% of those with fractures after the stroke received osteoporosis treatment after the stroke. Patients who were female, had prior osteoporosis, had experienced prior fracture, had previously undergone bone mineral density testing, or had experienced a fracture or fall after their stroke were more likely to receive osteoporosis pharmacotherapy.

The authors found that the neither the severity of stroke nor the presence of other comorbidities was associated with an increased likelihood of screening or treatment of osteoporosis after the stroke.

Stroke is associated with up to a fourfold increased risk of osteoporosis and fracture, compared with healthy controls, most probably because of reduced mobility and an increased risk of falls, wrote Eshita Kapoor of the department of medicine at the University of Toronto and her coauthors.

“Screening and treatment may be particularly low poststroke because of under-recognition of osteoporosis as a consequence of stroke, a selective focus on the management of cardiovascular risk and stroke recovery, or factors such as dysphagia precluding use of oral bisphosphonates,” the authors wrote.

While the association is noted in U.S. stroke guidelines, there are few recommendations for treatment aside from fall prevention strategies, which the authors noted was a missed opportunity for prevention.

“Use of a risk prediction score to identify those at particularly high short-term risk of fractures after stroke may help to prioritize patients for osteoporosis testing and treatment,” they suggested.

The study was funded by the Heart and Stroke Foundation of Canada and was supported by ICES (Institute for Clinical Evaluative Sciences) and the Ontario Ministry of Health and Long-Term Care. One author declared consultancies for the pharmaceutical sector. No other conflicts of interest were declared.

SOURCE: Kapoor E et al. Stroke. 2019 April 25. doi: 10.1161/STROKEAHA.118.024685
 

LOS ANGELES – A significantly higher proportion of euthyroid patients with thyroid disease suffer from anxiety than from depression, regardless of Hashimoto’s autoimmunity, results from a cross-sectional study have shown.

“Thyroid disease is often associated with impaired quality of life and psychological well-being,” lead study author Anette Merke, MD, MS, said in an interview in advance of the annual scientific and clinical congress of the American Association of Clinical Endocrinologists. “In daily practice, anxiety and depression complaints are common in patients with thyroid dysfunctions. While depressive symptoms are often associated with hypothyroidism, anxiety is claimed to be mainly linked to hyperthyroidism. Data on euthyroid patients with thyroid disease are controversial. Some studies point out that autoimmunity itself contributes to psychosomatic malfunctions. Overall, the mechanisms underlying the interaction between thyroid dysfunction and neuropsychiatric processes are still unknown.”

Dr. Merke, of the Thyroid Center Bergstrasse in Bensheim, Germany, and her husband/coauthor Jüergen Merke, MD, PhD, used the self-administered German version of the validated Hospital Anxiety and Depression Scale (HADS-D) to perform a cross-sectional study of 215 euthyroid adults with thyroid disease between January and February of 2019. Of the 14 items on the measure, half relate to anxiety and the other half to depression. Each item on the HADS-D is scored from 0-3, and a score of 10 or higher is considered a positive case of anxiety or depression. Patients completed the HADS-D within 3 months of routine lab testing, and the researchers collected the patients’ demographic data after they had assessed the individual scores.

Of the 215 study participants, most (89%) were women, the mean age was 47 years, and the mean anxiety and depression scores were 6.68 and 4.68, respectively (P = .0001). There was no significant difference in severity with respect to anxiety or depression. Of the 70 patients (33%) with antibody-positive Hashimoto’s thyroiditis, the mean anxiety and depression scores were 7.26 and 4.17.


In patients with HADS-D scores of 10 or greater, 50 (23%) had prominent anxiety scores (mean, 12.4), whereas 22 (10%) had prominent depression scores (mean, 13.18). Among the subset of Hashimoto’s thyroiditis patients, 18 (26%) had a mean anxiety score of 12.6 and 8 (11%) had a mean depression score of 13.18. Overall, significantly more cases were found in those who met criteria for anxiety, compared with those who met criteria for depression (P = .0001), with no significant difference in severity of either condition.

Depressive symptoms are usually more closely associated with thyroid disease, and there are more studies that have examined that relationship, so “we were surprised to find no significant difference in depressive symptoms between our study cohort and the German general population,” Dr. Merke said. “We were also surprised that anxiety had a significantly higher incidence in the cohort.”

The findings suggest that clinicians should focus on signs of anxiety symptoms when dealing with euthyroid patients with thyroid disease who report psychosomatic impairments, she continued, especially when patients complain of not being able to relax and release somatic tension.

“According to HADS, fears and worries are an expression of anxiety, and not of depression,” Dr. Merke said. “With this in mind, doctors [should] actively ask [about] the above-mentioned symptoms and advise patients to learn relaxation techniques to improve their quality of life. Interdisciplinary collaboration is needed between clinicians and psychotherapeutic professionals for the sake of the patients and to evaluate a cause-and-effect relationship and potential risk factors for development of psychosomatic cofactors in thyroid and other chronic somatic diseases. We should all be aware that misinterpretation or even denial of psychosomatic complaints may lead to complications and even a higher mortality of somatic diseases, as shown for chronic heart failure. This could also be true for thyroid disease.”

Dr Merke acknowledged certain limitations of the study, including the fact that neither the duration of thyroid disease nor the use of specific thyroid medications was assessed. In addition, “the definition of euthyroidism in our study is somewhat broad, especially compared with the recommendations of the [American Association of Clinical Endocrinologists],” she said. “Division of the respective thyroid hormone status into quartiles may be helpful to indicate the critical thyroid hormone serum concentration, which may be associated with clinically relevant anxiety symptoms in euthyroid patients.”

Dr. Merke reported having no financial disclosures or conflict of interest.

dbrunk@mdedge.com

LOS ANGELES – A significantly higher proportion of euthyroid patients with thyroid disease suffer from anxiety than from depression, regardless of Hashimoto’s autoimmunity, results from a cross-sectional study have shown.

“Thyroid disease is often associated with impaired quality of life and psychological well-being,” lead study author Anette Merke, MD, MS, said in an interview in advance of the annual scientific and clinical congress of the American Association of Clinical Endocrinologists. “In daily practice, anxiety and depression complaints are common in patients with thyroid dysfunctions. While depressive symptoms are often associated with hypothyroidism, anxiety is claimed to be mainly linked to hyperthyroidism. Data on euthyroid patients with thyroid disease are controversial. Some studies point out that autoimmunity itself contributes to psychosomatic malfunctions. Overall, the mechanisms underlying the interaction between thyroid dysfunction and neuropsychiatric processes are still unknown.”

Dr. Merke, of the Thyroid Center Bergstrasse in Bensheim, Germany, and her husband/coauthor Jüergen Merke, MD, PhD, used the self-administered German version of the validated Hospital Anxiety and Depression Scale (HADS-D) to perform a cross-sectional study of 215 euthyroid adults with thyroid disease between January and February of 2019. Of the 14 items on the measure, half relate to anxiety and the other half to depression. Each item on the HADS-D is scored from 0-3, and a score of 10 or higher is considered a positive case of anxiety or depression. Patients completed the HADS-D within 3 months of routine lab testing, and the researchers collected the patients’ demographic data after they had assessed the individual scores.

Of the 215 study participants, most (89%) were women, the mean age was 47 years, and the mean anxiety and depression scores were 6.68 and 4.68, respectively (P = .0001). There was no significant difference in severity with respect to anxiety or depression. Of the 70 patients (33%) with antibody-positive Hashimoto’s thyroiditis, the mean anxiety and depression scores were 7.26 and 4.17.


In patients with HADS-D scores of 10 or greater, 50 (23%) had prominent anxiety scores (mean, 12.4), whereas 22 (10%) had prominent depression scores (mean, 13.18). Among the subset of Hashimoto’s thyroiditis patients, 18 (26%) had a mean anxiety score of 12.6 and 8 (11%) had a mean depression score of 13.18. Overall, significantly more cases were found in those who met criteria for anxiety, compared with those who met criteria for depression (P = .0001), with no significant difference in severity of either condition.

Depressive symptoms are usually more closely associated with thyroid disease, and there are more studies that have examined that relationship, so “we were surprised to find no significant difference in depressive symptoms between our study cohort and the German general population,” Dr. Merke said. “We were also surprised that anxiety had a significantly higher incidence in the cohort.”

The findings suggest that clinicians should focus on signs of anxiety symptoms when dealing with euthyroid patients with thyroid disease who report psychosomatic impairments, she continued, especially when patients complain of not being able to relax and release somatic tension.

“According to HADS, fears and worries are an expression of anxiety, and not of depression,” Dr. Merke said. “With this in mind, doctors [should] actively ask [about] the above-mentioned symptoms and advise patients to learn relaxation techniques to improve their quality of life. Interdisciplinary collaboration is needed between clinicians and psychotherapeutic professionals for the sake of the patients and to evaluate a cause-and-effect relationship and potential risk factors for development of psychosomatic cofactors in thyroid and other chronic somatic diseases. We should all be aware that misinterpretation or even denial of psychosomatic complaints may lead to complications and even a higher mortality of somatic diseases, as shown for chronic heart failure. This could also be true for thyroid disease.”

Dr Merke acknowledged certain limitations of the study, including the fact that neither the duration of thyroid disease nor the use of specific thyroid medications was assessed. In addition, “the definition of euthyroidism in our study is somewhat broad, especially compared with the recommendations of the [American Association of Clinical Endocrinologists],” she said. “Division of the respective thyroid hormone status into quartiles may be helpful to indicate the critical thyroid hormone serum concentration, which may be associated with clinically relevant anxiety symptoms in euthyroid patients.”

Dr. Merke reported having no financial disclosures or conflict of interest.

dbrunk@mdedge.com

LOS ANGELES – A significantly higher proportion of euthyroid patients with thyroid disease suffer from anxiety than from depression, regardless of Hashimoto’s autoimmunity, results from a cross-sectional study have shown.

“Thyroid disease is often associated with impaired quality of life and psychological well-being,” lead study author Anette Merke, MD, MS, said in an interview in advance of the annual scientific and clinical congress of the American Association of Clinical Endocrinologists. “In daily practice, anxiety and depression complaints are common in patients with thyroid dysfunctions. While depressive symptoms are often associated with hypothyroidism, anxiety is claimed to be mainly linked to hyperthyroidism. Data on euthyroid patients with thyroid disease are controversial. Some studies point out that autoimmunity itself contributes to psychosomatic malfunctions. Overall, the mechanisms underlying the interaction between thyroid dysfunction and neuropsychiatric processes are still unknown.”

Dr. Merke, of the Thyroid Center Bergstrasse in Bensheim, Germany, and her husband/coauthor Jüergen Merke, MD, PhD, used the self-administered German version of the validated Hospital Anxiety and Depression Scale (HADS-D) to perform a cross-sectional study of 215 euthyroid adults with thyroid disease between January and February of 2019. Of the 14 items on the measure, half relate to anxiety and the other half to depression. Each item on the HADS-D is scored from 0-3, and a score of 10 or higher is considered a positive case of anxiety or depression. Patients completed the HADS-D within 3 months of routine lab testing, and the researchers collected the patients’ demographic data after they had assessed the individual scores.

Of the 215 study participants, most (89%) were women, the mean age was 47 years, and the mean anxiety and depression scores were 6.68 and 4.68, respectively (P = .0001). There was no significant difference in severity with respect to anxiety or depression. Of the 70 patients (33%) with antibody-positive Hashimoto’s thyroiditis, the mean anxiety and depression scores were 7.26 and 4.17.


In patients with HADS-D scores of 10 or greater, 50 (23%) had prominent anxiety scores (mean, 12.4), whereas 22 (10%) had prominent depression scores (mean, 13.18). Among the subset of Hashimoto’s thyroiditis patients, 18 (26%) had a mean anxiety score of 12.6 and 8 (11%) had a mean depression score of 13.18. Overall, significantly more cases were found in those who met criteria for anxiety, compared with those who met criteria for depression (P = .0001), with no significant difference in severity of either condition.

Depressive symptoms are usually more closely associated with thyroid disease, and there are more studies that have examined that relationship, so “we were surprised to find no significant difference in depressive symptoms between our study cohort and the German general population,” Dr. Merke said. “We were also surprised that anxiety had a significantly higher incidence in the cohort.”

The findings suggest that clinicians should focus on signs of anxiety symptoms when dealing with euthyroid patients with thyroid disease who report psychosomatic impairments, she continued, especially when patients complain of not being able to relax and release somatic tension.

“According to HADS, fears and worries are an expression of anxiety, and not of depression,” Dr. Merke said. “With this in mind, doctors [should] actively ask [about] the above-mentioned symptoms and advise patients to learn relaxation techniques to improve their quality of life. Interdisciplinary collaboration is needed between clinicians and psychotherapeutic professionals for the sake of the patients and to evaluate a cause-and-effect relationship and potential risk factors for development of psychosomatic cofactors in thyroid and other chronic somatic diseases. We should all be aware that misinterpretation or even denial of psychosomatic complaints may lead to complications and even a higher mortality of somatic diseases, as shown for chronic heart failure. This could also be true for thyroid disease.”

Dr Merke acknowledged certain limitations of the study, including the fact that neither the duration of thyroid disease nor the use of specific thyroid medications was assessed. In addition, “the definition of euthyroidism in our study is somewhat broad, especially compared with the recommendations of the [American Association of Clinical Endocrinologists],” she said. “Division of the respective thyroid hormone status into quartiles may be helpful to indicate the critical thyroid hormone serum concentration, which may be associated with clinically relevant anxiety symptoms in euthyroid patients.”

Dr. Merke reported having no financial disclosures or conflict of interest.

dbrunk@mdedge.com

A project to improve how hospitalists address inpatient delirium, which has led to reductions in length of stay and cost, took center stage in the Best of RIV plenary session at HM19 in March.

The project, conducted at the University of California, San Francisco (UCSF), was presented alongside projects on alcohol detox at the Cleveland Veterans Affairs Medical Center and on medication reconciliation at Brigham and Women’s Hospital in Boston.

“The plenary is the top three of the 1,000 that are out there – so, impressive work,” said Benji Mathews, MD, SFHM, the chair of the Research, Innovations and Vignettes competition.

At UCSF, the project was meant to tackle the huge problem of delirium in the hospital, said Catherine Lau, MD, SFHM, associate professor of medicine there. Each year delirium affects more than 7 million people who are hospitalized, and hospital-acquired delirium is linked with prolonged stays and more emergency department visits and hospital readmissions. But research has found that as many as a third of these hospital-acquired cases can be prevented, Dr. Lau said.

New admissions and transfers – a total of more than 2,800 patients – were assessed for delirium risk, and those deemed high risk were entered into a delirium care plan, aimed at prevention with nonpharmacologic steps such as maximizing their mobility and helping them sleep at night.

All patients also were screened on every nursing shift for delirium, and those diagnosed with the disorder were placed in the delirium care plan, with notification of the patient’s team for treatment.

The average length of stay decreased by 0.8 days (P less than .001), with a decrease of 1.9 days in patients with delirium, compared with outcomes for nearly 2,600 patients before the intervention was implemented, Dr. Lau said. Researchers also found a decrease in $850 spent per patient (P less than .001), with a direct savings to the hospital of a total of $997,000, she said. The 30-day readmission rate also fell significantly, from 18.9% to 15.9% (P = .03).

The screening itself seemed to be the most important factor in the project, Dr. Lau said.

“Just the recognition that their patient was at risk for delirium or actually had delirium really raised awareness,” she said.

A project to improve how hospitalists address inpatient delirium, which has led to reductions in length of stay and cost, took center stage in the Best of RIV plenary session at HM19 in March.

The project, conducted at the University of California, San Francisco (UCSF), was presented alongside projects on alcohol detox at the Cleveland Veterans Affairs Medical Center and on medication reconciliation at Brigham and Women’s Hospital in Boston.

“The plenary is the top three of the 1,000 that are out there – so, impressive work,” said Benji Mathews, MD, SFHM, the chair of the Research, Innovations and Vignettes competition.

At UCSF, the project was meant to tackle the huge problem of delirium in the hospital, said Catherine Lau, MD, SFHM, associate professor of medicine there. Each year delirium affects more than 7 million people who are hospitalized, and hospital-acquired delirium is linked with prolonged stays and more emergency department visits and hospital readmissions. But research has found that as many as a third of these hospital-acquired cases can be prevented, Dr. Lau said.

New admissions and transfers – a total of more than 2,800 patients – were assessed for delirium risk, and those deemed high risk were entered into a delirium care plan, aimed at prevention with nonpharmacologic steps such as maximizing their mobility and helping them sleep at night.

All patients also were screened on every nursing shift for delirium, and those diagnosed with the disorder were placed in the delirium care plan, with notification of the patient’s team for treatment.

The average length of stay decreased by 0.8 days (P less than .001), with a decrease of 1.9 days in patients with delirium, compared with outcomes for nearly 2,600 patients before the intervention was implemented, Dr. Lau said. Researchers also found a decrease in $850 spent per patient (P less than .001), with a direct savings to the hospital of a total of $997,000, she said. The 30-day readmission rate also fell significantly, from 18.9% to 15.9% (P = .03).

The screening itself seemed to be the most important factor in the project, Dr. Lau said.

“Just the recognition that their patient was at risk for delirium or actually had delirium really raised awareness,” she said.

A project to improve how hospitalists address inpatient delirium, which has led to reductions in length of stay and cost, took center stage in the Best of RIV plenary session at HM19 in March.

The project, conducted at the University of California, San Francisco (UCSF), was presented alongside projects on alcohol detox at the Cleveland Veterans Affairs Medical Center and on medication reconciliation at Brigham and Women’s Hospital in Boston.

“The plenary is the top three of the 1,000 that are out there – so, impressive work,” said Benji Mathews, MD, SFHM, the chair of the Research, Innovations and Vignettes competition.

At UCSF, the project was meant to tackle the huge problem of delirium in the hospital, said Catherine Lau, MD, SFHM, associate professor of medicine there. Each year delirium affects more than 7 million people who are hospitalized, and hospital-acquired delirium is linked with prolonged stays and more emergency department visits and hospital readmissions. But research has found that as many as a third of these hospital-acquired cases can be prevented, Dr. Lau said.

New admissions and transfers – a total of more than 2,800 patients – were assessed for delirium risk, and those deemed high risk were entered into a delirium care plan, aimed at prevention with nonpharmacologic steps such as maximizing their mobility and helping them sleep at night.

All patients also were screened on every nursing shift for delirium, and those diagnosed with the disorder were placed in the delirium care plan, with notification of the patient’s team for treatment.

The average length of stay decreased by 0.8 days (P less than .001), with a decrease of 1.9 days in patients with delirium, compared with outcomes for nearly 2,600 patients before the intervention was implemented, Dr. Lau said. Researchers also found a decrease in $850 spent per patient (P less than .001), with a direct savings to the hospital of a total of $997,000, she said. The 30-day readmission rate also fell significantly, from 18.9% to 15.9% (P = .03).

The screening itself seemed to be the most important factor in the project, Dr. Lau said.

“Just the recognition that their patient was at risk for delirium or actually had delirium really raised awareness,” she said.

LOS ANGELES – Patients with poor glycemic control, especially those with a hemoglobin A_1c (HbA_1c) level of more than 9%, face an increased risk for developing diabetic ketoacidosis (DKA), results from a registry study have demonstrated.

The findings come from an analysis of the 2016-2017 Type 1 Diabetes Exchange Clinic Registry dataset that researchers, led by Carol Wysham, MD, presented at the annual scientific and clinical congress of the American Association of Clinical Endocrinologists.

“This study is unique in that we have stratified patients based on A_1c, and identified factors and patient characteristics associated with a greater risk of DKA as glycemic control diminishes,” Dr. Wysham, an endocrinologist at MultiCare Rockwood Clinic Diabetes & Endocrinology Center in Spokane, Wash., said in advance of the meeting. “Multiple interrelated factors, such as lower levels of education and household income, relationship status, access to private health insurance, being younger, and smoking, all affect a patient’s ability to properly manage insulin dosing and are associated with a higher risk of DKA. Health care providers should continue to monitor and educate all patients on the risk factors associated with developing DKA, and be vigilant in patients with an A_1c of more than 9%.”

Dr. Wysham and her colleagues conducted a cross-sectional analysis of 6,242 patients in the registry. They examined associations between patient characteristics and treatment patterns with the occurrence of a DKA event in three categories of HbA_1c: 7% to less than 8%, 8% to less than 9%, and 9% or greater. The researchers used chi-square or Fisher exact tests to compare DKA and non-DKA groups for categorical variables and t tests to compare continuous variables.

Of the 6,242 patients, 43% had an HbA_1c from 7% to less than 8% (cohort 1), 31% had an HbA_1c of 8% to less than 9% (cohort 2), and 30% had an HbA_1c of 9% or greater (cohort 3). In all, 269 patients reported a DKA event. In addition, 1.7% of those in cohort 1 had a DKA episode versus 2.3% of those in cohort 2 and 9.5% of those in cohort 3.

In patients in cohort 1, the researchers observed no significant associations between individual patient demographic, socioeconomic, or treatment patterns and DKA incidence. In patients in cohort 2, race, marital status, insurance coverage, and annual household income were significantly associated with DKA incidence (P less than .01). In patients in cohort 3, DKA incidence was significantly associated with the same patterns as those in cohort 2, with the addition of age, type 1 diabetes duration, sex, education level, body mass index, and insulin delivery method (P less than .01).

On adjusted multivariate analysis, the researchers observed no significant associations between the factors studied and DKA in patients in cohort 2. In patients in cohort 3, only household income, smoking status, body mass index, and insulin delivery method (injection) were associated with DKA.

Dr. Wysham said she was surprised to learn that the patient characteristics and socioeconomic factors associated with DKA in patients with an HbA_1c of more than 9% start to become less significant risk factors as patients achieved better glycemic control.

“Also, in the past, insulin pump users tended to have higher rates of DKA, compared with patients taking multiple daily insulin injections,” she said. “That phenomenon no longer seems to apply, and in this dataset, patients with an HbA_1c of more than 9% and who were taking multiple daily injections had significantly higher risk of DKA than did pump users. Insulin delivery method was not a contributing factor to DKA risk at all in patients with an HbA_1c of less than 9%.”

Dr. Wysham acknowledged certain limitations of the analysis, including the fact that the registry data “are collected from patients treated at diabetes centers of excellence and may not reflect the population as a whole. Data could have been collected from medical records and/or self-reported questionnaires from patients. Self-reported data are subjective and are limited to the patient’s own recollections.”

Dr. Wysham disclosed that she has received honoraria for advising, consulting, and/or speaking from Abbott, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Dexcom, Novo Nordisk, and Sanofi. She also disclosed having received research funding from Mylan and Novo Nordisk that went to her institution.

dbrunk@mdedge.com

LOS ANGELES – Patients with poor glycemic control, especially those with a hemoglobin A_1c (HbA_1c) level of more than 9%, face an increased risk for developing diabetic ketoacidosis (DKA), results from a registry study have demonstrated.

The findings come from an analysis of the 2016-2017 Type 1 Diabetes Exchange Clinic Registry dataset that researchers, led by Carol Wysham, MD, presented at the annual scientific and clinical congress of the American Association of Clinical Endocrinologists.

“This study is unique in that we have stratified patients based on A_1c, and identified factors and patient characteristics associated with a greater risk of DKA as glycemic control diminishes,” Dr. Wysham, an endocrinologist at MultiCare Rockwood Clinic Diabetes & Endocrinology Center in Spokane, Wash., said in advance of the meeting. “Multiple interrelated factors, such as lower levels of education and household income, relationship status, access to private health insurance, being younger, and smoking, all affect a patient’s ability to properly manage insulin dosing and are associated with a higher risk of DKA. Health care providers should continue to monitor and educate all patients on the risk factors associated with developing DKA, and be vigilant in patients with an A_1c of more than 9%.”

Dr. Wysham and her colleagues conducted a cross-sectional analysis of 6,242 patients in the registry. They examined associations between patient characteristics and treatment patterns with the occurrence of a DKA event in three categories of HbA_1c: 7% to less than 8%, 8% to less than 9%, and 9% or greater. The researchers used chi-square or Fisher exact tests to compare DKA and non-DKA groups for categorical variables and t tests to compare continuous variables.

Of the 6,242 patients, 43% had an HbA_1c from 7% to less than 8% (cohort 1), 31% had an HbA_1c of 8% to less than 9% (cohort 2), and 30% had an HbA_1c of 9% or greater (cohort 3). In all, 269 patients reported a DKA event. In addition, 1.7% of those in cohort 1 had a DKA episode versus 2.3% of those in cohort 2 and 9.5% of those in cohort 3.

In patients in cohort 1, the researchers observed no significant associations between individual patient demographic, socioeconomic, or treatment patterns and DKA incidence. In patients in cohort 2, race, marital status, insurance coverage, and annual household income were significantly associated with DKA incidence (P less than .01). In patients in cohort 3, DKA incidence was significantly associated with the same patterns as those in cohort 2, with the addition of age, type 1 diabetes duration, sex, education level, body mass index, and insulin delivery method (P less than .01).

On adjusted multivariate analysis, the researchers observed no significant associations between the factors studied and DKA in patients in cohort 2. In patients in cohort 3, only household income, smoking status, body mass index, and insulin delivery method (injection) were associated with DKA.

Dr. Wysham said she was surprised to learn that the patient characteristics and socioeconomic factors associated with DKA in patients with an HbA_1c of more than 9% start to become less significant risk factors as patients achieved better glycemic control.

“Also, in the past, insulin pump users tended to have higher rates of DKA, compared with patients taking multiple daily insulin injections,” she said. “That phenomenon no longer seems to apply, and in this dataset, patients with an HbA_1c of more than 9% and who were taking multiple daily injections had significantly higher risk of DKA than did pump users. Insulin delivery method was not a contributing factor to DKA risk at all in patients with an HbA_1c of less than 9%.”

Dr. Wysham acknowledged certain limitations of the analysis, including the fact that the registry data “are collected from patients treated at diabetes centers of excellence and may not reflect the population as a whole. Data could have been collected from medical records and/or self-reported questionnaires from patients. Self-reported data are subjective and are limited to the patient’s own recollections.”

Dr. Wysham disclosed that she has received honoraria for advising, consulting, and/or speaking from Abbott, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Dexcom, Novo Nordisk, and Sanofi. She also disclosed having received research funding from Mylan and Novo Nordisk that went to her institution.

dbrunk@mdedge.com

LOS ANGELES – Patients with poor glycemic control, especially those with a hemoglobin A_1c (HbA_1c) level of more than 9%, face an increased risk for developing diabetic ketoacidosis (DKA), results from a registry study have demonstrated.

The findings come from an analysis of the 2016-2017 Type 1 Diabetes Exchange Clinic Registry dataset that researchers, led by Carol Wysham, MD, presented at the annual scientific and clinical congress of the American Association of Clinical Endocrinologists.

“This study is unique in that we have stratified patients based on A_1c, and identified factors and patient characteristics associated with a greater risk of DKA as glycemic control diminishes,” Dr. Wysham, an endocrinologist at MultiCare Rockwood Clinic Diabetes & Endocrinology Center in Spokane, Wash., said in advance of the meeting. “Multiple interrelated factors, such as lower levels of education and household income, relationship status, access to private health insurance, being younger, and smoking, all affect a patient’s ability to properly manage insulin dosing and are associated with a higher risk of DKA. Health care providers should continue to monitor and educate all patients on the risk factors associated with developing DKA, and be vigilant in patients with an A_1c of more than 9%.”

Dr. Wysham and her colleagues conducted a cross-sectional analysis of 6,242 patients in the registry. They examined associations between patient characteristics and treatment patterns with the occurrence of a DKA event in three categories of HbA_1c: 7% to less than 8%, 8% to less than 9%, and 9% or greater. The researchers used chi-square or Fisher exact tests to compare DKA and non-DKA groups for categorical variables and t tests to compare continuous variables.

Of the 6,242 patients, 43% had an HbA_1c from 7% to less than 8% (cohort 1), 31% had an HbA_1c of 8% to less than 9% (cohort 2), and 30% had an HbA_1c of 9% or greater (cohort 3). In all, 269 patients reported a DKA event. In addition, 1.7% of those in cohort 1 had a DKA episode versus 2.3% of those in cohort 2 and 9.5% of those in cohort 3.

In patients in cohort 1, the researchers observed no significant associations between individual patient demographic, socioeconomic, or treatment patterns and DKA incidence. In patients in cohort 2, race, marital status, insurance coverage, and annual household income were significantly associated with DKA incidence (P less than .01). In patients in cohort 3, DKA incidence was significantly associated with the same patterns as those in cohort 2, with the addition of age, type 1 diabetes duration, sex, education level, body mass index, and insulin delivery method (P less than .01).

On adjusted multivariate analysis, the researchers observed no significant associations between the factors studied and DKA in patients in cohort 2. In patients in cohort 3, only household income, smoking status, body mass index, and insulin delivery method (injection) were associated with DKA.

Dr. Wysham said she was surprised to learn that the patient characteristics and socioeconomic factors associated with DKA in patients with an HbA_1c of more than 9% start to become less significant risk factors as patients achieved better glycemic control.

“Also, in the past, insulin pump users tended to have higher rates of DKA, compared with patients taking multiple daily insulin injections,” she said. “That phenomenon no longer seems to apply, and in this dataset, patients with an HbA_1c of more than 9% and who were taking multiple daily injections had significantly higher risk of DKA than did pump users. Insulin delivery method was not a contributing factor to DKA risk at all in patients with an HbA_1c of less than 9%.”

Dr. Wysham acknowledged certain limitations of the analysis, including the fact that the registry data “are collected from patients treated at diabetes centers of excellence and may not reflect the population as a whole. Data could have been collected from medical records and/or self-reported questionnaires from patients. Self-reported data are subjective and are limited to the patient’s own recollections.”

Dr. Wysham disclosed that she has received honoraria for advising, consulting, and/or speaking from Abbott, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Dexcom, Novo Nordisk, and Sanofi. She also disclosed having received research funding from Mylan and Novo Nordisk that went to her institution.

dbrunk@mdedge.com

LOS ANGELES – Following 6 months of treatment with the investigational agent levoketoconazole, several clinical signs and symptoms of Cushing’s disease improved, including acne, hirsutism, and peripheral edema, as did patient-reported quality of life and symptoms of depression.

The findings come from an analysis of secondary endpoints among patients enrolled in SONICS, an open-label, phase 3 study of levoketoconazole as a treatment for endogenous Cushing’s disease (CD) that enrolled 94 patients at centers in North America, Europe and the Middle East. An investigational cortisol synthesis inhibitor, levoketoconazole is being developed by Strongbridge Biopharma and is not yet approved by the Food and Drug Administration.

“Despite the availability of approved treatments, the medical needs in Cushing’s [disease] remain very high,” the study’s principal investigator, Maria Fleseriu, MD, FACE, said in an interview in advance of the annual scientific and clinical congress of the American Association of Clinical Endocrinologists, where the data were presented. “This study demonstrates that levoketoconazole has the potential to address several clinical features of Cushing’s, owing to its clinically translated novel mechanism of action to suppress both cortisol and androgen syntheses (the latter elevated in many women with CD). Interestingly, there was no evidence of clinically important free-T reduction in men, and more studies are needed to elucidate this mechanism.”

In SONICS, adults with confirmed CD and mean 24-hour urinary free-cortisol (mUFC) value at least 1.5 times the upper limit of normal were treated with levoketoconazole in three phases: 2- to 21-week dose-titration phase (150-600 mg BID, as needed, to target mUFC normalization); 6-month maintenance phase (primary endpoint); and 6-month extended evaluation phase. The end of maintenance phase findings that focused on reductions in mUFC and safety had been previously reported. The current analysis focused on secondary endpoints, including changes from baseline to end of maintenance in investigator-assessed CD clinical signs and symptoms (acne score [range: 0-44]; hirsutism score [women only; range: 0-36]; and peripheral edema score [range: 0-12]), and patient-reported outcomes of quality of life (Cushing QoL questionnaire score [range: 0-100]) and depression (Beck Depression Inventory II score [range: 0-63]). The researchers also assessed hormones including free testosterone levels, and they used paired t-tests to infer statistical significance of the mean changes from baseline to end of maintenance for all measures.

Of the 94 patients enrolled in SONICS, 77 entered the maintenance phase, said Dr. Fleseriu, professor of medicine and neurological surgery and director of the pituitary center at Oregon Health and Science University, Portland. The patients’ mean age was 44 years and mean baseline mUFC was 243.3 mcg/day; 82% of patients were female, and 96% were white. Between baseline and the end of maintenance, the researchers observed significant mean improvements in acne scores (from 2.8 to –1.8, respectively; P = .0063), hirsutism scores (women only, from 7.8 to –2.6; P = .0008), and peripheral edema scores (from 1.0 to –0.4; P = .0295). They also observed significant mean improvements in quality of life and depression scores between baseline and end of maintenance (P less than .0001 and P = .0043, respectively). Mean free-testosterone levels increased nonsignificantly between baseline and end of maintenance in men (from 5.1 to 5.8 ng/dL) yet decreased significantly in women (from 0.3 to 0.1 ng/dL; P less than 0.0001; reference). Overall, 33 patients (35%) discontinued taking levoketoconazole by the end of the maintenance phase. Twelve (13%) discontinued because of adverse events.

“I wasn’t necessarily surprised with any of the data in this poster as I had experience with the drug in clinical trials, but I was definitely pleased to see overall significant improvements in acne score, hirsutism score in women, and peripheral edema score,” Dr. Fleseriu said. “Those are benefits that could potentially increase long-term adherence to treatment and quality-of-life improvements, particularly in women. It’s also exciting to see that quality of life and depression improved in these patients as well.”

These types of patient-reported outcomes are so important to how our patients feel about their disease and should be more of a focus for us physicians; it’s important to look at efficacy, safety and patient reported outcomes when we decide for an individualized treatment for each patient,” she noted.

Dr. Fleseriu reported that she has received research funding for Oregon Health and Science University from Novartis, Millendo, and Strongbridge. She has also received scientific consulting fees from Novartis and Strongbridge.

dbrunk@mdedge.com

LOS ANGELES – Following 6 months of treatment with the investigational agent levoketoconazole, several clinical signs and symptoms of Cushing’s disease improved, including acne, hirsutism, and peripheral edema, as did patient-reported quality of life and symptoms of depression.

The findings come from an analysis of secondary endpoints among patients enrolled in SONICS, an open-label, phase 3 study of levoketoconazole as a treatment for endogenous Cushing’s disease (CD) that enrolled 94 patients at centers in North America, Europe and the Middle East. An investigational cortisol synthesis inhibitor, levoketoconazole is being developed by Strongbridge Biopharma and is not yet approved by the Food and Drug Administration.

“Despite the availability of approved treatments, the medical needs in Cushing’s [disease] remain very high,” the study’s principal investigator, Maria Fleseriu, MD, FACE, said in an interview in advance of the annual scientific and clinical congress of the American Association of Clinical Endocrinologists, where the data were presented. “This study demonstrates that levoketoconazole has the potential to address several clinical features of Cushing’s, owing to its clinically translated novel mechanism of action to suppress both cortisol and androgen syntheses (the latter elevated in many women with CD). Interestingly, there was no evidence of clinically important free-T reduction in men, and more studies are needed to elucidate this mechanism.”

In SONICS, adults with confirmed CD and mean 24-hour urinary free-cortisol (mUFC) value at least 1.5 times the upper limit of normal were treated with levoketoconazole in three phases: 2- to 21-week dose-titration phase (150-600 mg BID, as needed, to target mUFC normalization); 6-month maintenance phase (primary endpoint); and 6-month extended evaluation phase. The end of maintenance phase findings that focused on reductions in mUFC and safety had been previously reported. The current analysis focused on secondary endpoints, including changes from baseline to end of maintenance in investigator-assessed CD clinical signs and symptoms (acne score [range: 0-44]; hirsutism score [women only; range: 0-36]; and peripheral edema score [range: 0-12]), and patient-reported outcomes of quality of life (Cushing QoL questionnaire score [range: 0-100]) and depression (Beck Depression Inventory II score [range: 0-63]). The researchers also assessed hormones including free testosterone levels, and they used paired t-tests to infer statistical significance of the mean changes from baseline to end of maintenance for all measures.

Of the 94 patients enrolled in SONICS, 77 entered the maintenance phase, said Dr. Fleseriu, professor of medicine and neurological surgery and director of the pituitary center at Oregon Health and Science University, Portland. The patients’ mean age was 44 years and mean baseline mUFC was 243.3 mcg/day; 82% of patients were female, and 96% were white. Between baseline and the end of maintenance, the researchers observed significant mean improvements in acne scores (from 2.8 to –1.8, respectively; P = .0063), hirsutism scores (women only, from 7.8 to –2.6; P = .0008), and peripheral edema scores (from 1.0 to –0.4; P = .0295). They also observed significant mean improvements in quality of life and depression scores between baseline and end of maintenance (P less than .0001 and P = .0043, respectively). Mean free-testosterone levels increased nonsignificantly between baseline and end of maintenance in men (from 5.1 to 5.8 ng/dL) yet decreased significantly in women (from 0.3 to 0.1 ng/dL; P less than 0.0001; reference). Overall, 33 patients (35%) discontinued taking levoketoconazole by the end of the maintenance phase. Twelve (13%) discontinued because of adverse events.

“I wasn’t necessarily surprised with any of the data in this poster as I had experience with the drug in clinical trials, but I was definitely pleased to see overall significant improvements in acne score, hirsutism score in women, and peripheral edema score,” Dr. Fleseriu said. “Those are benefits that could potentially increase long-term adherence to treatment and quality-of-life improvements, particularly in women. It’s also exciting to see that quality of life and depression improved in these patients as well.”

These types of patient-reported outcomes are so important to how our patients feel about their disease and should be more of a focus for us physicians; it’s important to look at efficacy, safety and patient reported outcomes when we decide for an individualized treatment for each patient,” she noted.

Dr. Fleseriu reported that she has received research funding for Oregon Health and Science University from Novartis, Millendo, and Strongbridge. She has also received scientific consulting fees from Novartis and Strongbridge.

dbrunk@mdedge.com

LOS ANGELES – Following 6 months of treatment with the investigational agent levoketoconazole, several clinical signs and symptoms of Cushing’s disease improved, including acne, hirsutism, and peripheral edema, as did patient-reported quality of life and symptoms of depression.

The findings come from an analysis of secondary endpoints among patients enrolled in SONICS, an open-label, phase 3 study of levoketoconazole as a treatment for endogenous Cushing’s disease (CD) that enrolled 94 patients at centers in North America, Europe and the Middle East. An investigational cortisol synthesis inhibitor, levoketoconazole is being developed by Strongbridge Biopharma and is not yet approved by the Food and Drug Administration.

“Despite the availability of approved treatments, the medical needs in Cushing’s [disease] remain very high,” the study’s principal investigator, Maria Fleseriu, MD, FACE, said in an interview in advance of the annual scientific and clinical congress of the American Association of Clinical Endocrinologists, where the data were presented. “This study demonstrates that levoketoconazole has the potential to address several clinical features of Cushing’s, owing to its clinically translated novel mechanism of action to suppress both cortisol and androgen syntheses (the latter elevated in many women with CD). Interestingly, there was no evidence of clinically important free-T reduction in men, and more studies are needed to elucidate this mechanism.”

In SONICS, adults with confirmed CD and mean 24-hour urinary free-cortisol (mUFC) value at least 1.5 times the upper limit of normal were treated with levoketoconazole in three phases: 2- to 21-week dose-titration phase (150-600 mg BID, as needed, to target mUFC normalization); 6-month maintenance phase (primary endpoint); and 6-month extended evaluation phase. The end of maintenance phase findings that focused on reductions in mUFC and safety had been previously reported. The current analysis focused on secondary endpoints, including changes from baseline to end of maintenance in investigator-assessed CD clinical signs and symptoms (acne score [range: 0-44]; hirsutism score [women only; range: 0-36]; and peripheral edema score [range: 0-12]), and patient-reported outcomes of quality of life (Cushing QoL questionnaire score [range: 0-100]) and depression (Beck Depression Inventory II score [range: 0-63]). The researchers also assessed hormones including free testosterone levels, and they used paired t-tests to infer statistical significance of the mean changes from baseline to end of maintenance for all measures.

Of the 94 patients enrolled in SONICS, 77 entered the maintenance phase, said Dr. Fleseriu, professor of medicine and neurological surgery and director of the pituitary center at Oregon Health and Science University, Portland. The patients’ mean age was 44 years and mean baseline mUFC was 243.3 mcg/day; 82% of patients were female, and 96% were white. Between baseline and the end of maintenance, the researchers observed significant mean improvements in acne scores (from 2.8 to –1.8, respectively; P = .0063), hirsutism scores (women only, from 7.8 to –2.6; P = .0008), and peripheral edema scores (from 1.0 to –0.4; P = .0295). They also observed significant mean improvements in quality of life and depression scores between baseline and end of maintenance (P less than .0001 and P = .0043, respectively). Mean free-testosterone levels increased nonsignificantly between baseline and end of maintenance in men (from 5.1 to 5.8 ng/dL) yet decreased significantly in women (from 0.3 to 0.1 ng/dL; P less than 0.0001; reference). Overall, 33 patients (35%) discontinued taking levoketoconazole by the end of the maintenance phase. Twelve (13%) discontinued because of adverse events.

“I wasn’t necessarily surprised with any of the data in this poster as I had experience with the drug in clinical trials, but I was definitely pleased to see overall significant improvements in acne score, hirsutism score in women, and peripheral edema score,” Dr. Fleseriu said. “Those are benefits that could potentially increase long-term adherence to treatment and quality-of-life improvements, particularly in women. It’s also exciting to see that quality of life and depression improved in these patients as well.”

These types of patient-reported outcomes are so important to how our patients feel about their disease and should be more of a focus for us physicians; it’s important to look at efficacy, safety and patient reported outcomes when we decide for an individualized treatment for each patient,” she noted.

Dr. Fleseriu reported that she has received research funding for Oregon Health and Science University from Novartis, Millendo, and Strongbridge. She has also received scientific consulting fees from Novartis and Strongbridge.

dbrunk@mdedge.com