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BOSTON – A company that partners patients and health advisers claims to help patients with type 2 diabetes to manage their symptoms and lower their HbA_1c levels.

The Pack Health program connects each patient with a health adviser, who contacts them five times a week using a mix of phone calls, text messages, and emails. The goals include helping patients to find clinicians in their area, make appointments, and adhere to treatment, Dhiren Patel, PharmD, medical director at Pack Health, said at the annual meeting of the American Association of Clinical Endocrinologists.

In a prospective study of 756 type 2 diabetes patients, traditional modes of communication with a health coach were associated with a 1% decrease in HbA_1c within 3 months and the reduction was maintained at 1 year. Patients lost an average of 5 pounds, and annual eye and foot exams increased by 17% and 19%, respectively.

Similar remote health coach initiatives are being used to help other patients with chronic health conditions as part of the Pack Health services, which Dr. Patel discussed in a video interview.

[email protected]

SOURCE: Patel D et al. AACE 2018. Abstract 1209.

BOSTON – A company that partners patients and health advisers claims to help patients with type 2 diabetes to manage their symptoms and lower their HbA_1c levels.

The Pack Health program connects each patient with a health adviser, who contacts them five times a week using a mix of phone calls, text messages, and emails. The goals include helping patients to find clinicians in their area, make appointments, and adhere to treatment, Dhiren Patel, PharmD, medical director at Pack Health, said at the annual meeting of the American Association of Clinical Endocrinologists.

In a prospective study of 756 type 2 diabetes patients, traditional modes of communication with a health coach were associated with a 1% decrease in HbA_1c within 3 months and the reduction was maintained at 1 year. Patients lost an average of 5 pounds, and annual eye and foot exams increased by 17% and 19%, respectively.

Similar remote health coach initiatives are being used to help other patients with chronic health conditions as part of the Pack Health services, which Dr. Patel discussed in a video interview.

[email protected]

SOURCE: Patel D et al. AACE 2018. Abstract 1209.

BOSTON – A company that partners patients and health advisers claims to help patients with type 2 diabetes to manage their symptoms and lower their HbA_1c levels.

The Pack Health program connects each patient with a health adviser, who contacts them five times a week using a mix of phone calls, text messages, and emails. The goals include helping patients to find clinicians in their area, make appointments, and adhere to treatment, Dhiren Patel, PharmD, medical director at Pack Health, said at the annual meeting of the American Association of Clinical Endocrinologists.

In a prospective study of 756 type 2 diabetes patients, traditional modes of communication with a health coach were associated with a 1% decrease in HbA_1c within 3 months and the reduction was maintained at 1 year. Patients lost an average of 5 pounds, and annual eye and foot exams increased by 17% and 19%, respectively.

Similar remote health coach initiatives are being used to help other patients with chronic health conditions as part of the Pack Health services, which Dr. Patel discussed in a video interview.

[email protected]

SOURCE: Patel D et al. AACE 2018. Abstract 1209.

BOSTON – In a large, long-term study of canagliflozin versus placebo, an excess of discontinuations in the placebo group contributed to a dampening in the magnitude of improvement in hemoglobin A_1c.

That’s according to investigators who reported the findings at the annual meeting of the American Association of Clinical Endocrinologists.

A higher rate of starting new antihyperglycemic agents in the placebo arm also likely contributed to the decrease in the difference in HbA_1c after 52 weeks in CANVAS (Canagliflozin Cardiovascular Assessment Study), according to investigator Carol Wysham, MD, of the University of Washington, Spokane.

As previously reported, the two randomized trials in the CANVAS program showed that canagliflozin reduced risk of cardiovascular events in patients with type 2 diabetes at elevated risk of cardiovascular disease.

While the CANVAS program was not designed to assess glucose lowering – and, in fact, allowed adjustment of background antihyperglycemic agents at any time – canagliflozin patients were more likely than placebo-treated patients to achieve HbA_1c less than 7.0%.

However, the mean placebo-subtracted reduction in HbA_1c peaked at –0.64% at week 26 but shrank to –0.24% by week 338, the end of the study.

“In this case, [the analysis] is helping to understand why we might have seen a deterioration in A_1c control over a very long period of time,” Dr. Wysham explained.

SOURCE: Wysham C et al. AACE 2018, Abstract 262.

BOSTON – In a large, long-term study of canagliflozin versus placebo, an excess of discontinuations in the placebo group contributed to a dampening in the magnitude of improvement in hemoglobin A_1c.

That’s according to investigators who reported the findings at the annual meeting of the American Association of Clinical Endocrinologists.

A higher rate of starting new antihyperglycemic agents in the placebo arm also likely contributed to the decrease in the difference in HbA_1c after 52 weeks in CANVAS (Canagliflozin Cardiovascular Assessment Study), according to investigator Carol Wysham, MD, of the University of Washington, Spokane.

As previously reported, the two randomized trials in the CANVAS program showed that canagliflozin reduced risk of cardiovascular events in patients with type 2 diabetes at elevated risk of cardiovascular disease.

While the CANVAS program was not designed to assess glucose lowering – and, in fact, allowed adjustment of background antihyperglycemic agents at any time – canagliflozin patients were more likely than placebo-treated patients to achieve HbA_1c less than 7.0%.

However, the mean placebo-subtracted reduction in HbA_1c peaked at –0.64% at week 26 but shrank to –0.24% by week 338, the end of the study.

“In this case, [the analysis] is helping to understand why we might have seen a deterioration in A_1c control over a very long period of time,” Dr. Wysham explained.

SOURCE: Wysham C et al. AACE 2018, Abstract 262.

BOSTON – In a large, long-term study of canagliflozin versus placebo, an excess of discontinuations in the placebo group contributed to a dampening in the magnitude of improvement in hemoglobin A_1c.

That’s according to investigators who reported the findings at the annual meeting of the American Association of Clinical Endocrinologists.

A higher rate of starting new antihyperglycemic agents in the placebo arm also likely contributed to the decrease in the difference in HbA_1c after 52 weeks in CANVAS (Canagliflozin Cardiovascular Assessment Study), according to investigator Carol Wysham, MD, of the University of Washington, Spokane.

As previously reported, the two randomized trials in the CANVAS program showed that canagliflozin reduced risk of cardiovascular events in patients with type 2 diabetes at elevated risk of cardiovascular disease.

While the CANVAS program was not designed to assess glucose lowering – and, in fact, allowed adjustment of background antihyperglycemic agents at any time – canagliflozin patients were more likely than placebo-treated patients to achieve HbA_1c less than 7.0%.

However, the mean placebo-subtracted reduction in HbA_1c peaked at –0.64% at week 26 but shrank to –0.24% by week 338, the end of the study.

“In this case, [the analysis] is helping to understand why we might have seen a deterioration in A_1c control over a very long period of time,” Dr. Wysham explained.

SOURCE: Wysham C et al. AACE 2018, Abstract 262.

BOSTON – Men with acromegaly present at a younger age, have higher IGF-1 levels, and achieve lower biochemical control rates than women with the disorder, according to study results presented at the annual meeting of the American Association of Clinical Endocrinologists.

The study was based on data for 112 patients (54 male, 58 female) operated on by one neurosurgeon between 1994 and 2016. The mean age at surgery was 43.6 years in men and 48.7 in women (P = .04), according to Talin Handa, Emory University, Atlanta, who presented the retrospective analysis.

Men had higher mean IGF-1 levels (874 ng/mL vs. 716 ng/mL for women; P less than .01), and were more likely to have hypopituitarism.

Adjuvant treatment for acromegaly was needed in 57% of men and 49% of women. Following adjuvant treatment, 72% of men maintained surgical remission or achieved normal IGF-1 levels, compared with 89% of women (P = .03). Mean follow-up was shorter in men, 3.6 years, versus 5.2 years for women (P = .02), the researchers reported.

Six-year event-free survival was higher in women (P less than .01), according to the researchers.

For more study findings, watch our video interview.

SOURCE: Handa T et al. AACE 2018. Abstract #824.

BOSTON – Men with acromegaly present at a younger age, have higher IGF-1 levels, and achieve lower biochemical control rates than women with the disorder, according to study results presented at the annual meeting of the American Association of Clinical Endocrinologists.

The study was based on data for 112 patients (54 male, 58 female) operated on by one neurosurgeon between 1994 and 2016. The mean age at surgery was 43.6 years in men and 48.7 in women (P = .04), according to Talin Handa, Emory University, Atlanta, who presented the retrospective analysis.

Men had higher mean IGF-1 levels (874 ng/mL vs. 716 ng/mL for women; P less than .01), and were more likely to have hypopituitarism.

Adjuvant treatment for acromegaly was needed in 57% of men and 49% of women. Following adjuvant treatment, 72% of men maintained surgical remission or achieved normal IGF-1 levels, compared with 89% of women (P = .03). Mean follow-up was shorter in men, 3.6 years, versus 5.2 years for women (P = .02), the researchers reported.

Six-year event-free survival was higher in women (P less than .01), according to the researchers.

For more study findings, watch our video interview.

SOURCE: Handa T et al. AACE 2018. Abstract #824.

BOSTON – Men with acromegaly present at a younger age, have higher IGF-1 levels, and achieve lower biochemical control rates than women with the disorder, according to study results presented at the annual meeting of the American Association of Clinical Endocrinologists.

The study was based on data for 112 patients (54 male, 58 female) operated on by one neurosurgeon between 1994 and 2016. The mean age at surgery was 43.6 years in men and 48.7 in women (P = .04), according to Talin Handa, Emory University, Atlanta, who presented the retrospective analysis.

Men had higher mean IGF-1 levels (874 ng/mL vs. 716 ng/mL for women; P less than .01), and were more likely to have hypopituitarism.

Adjuvant treatment for acromegaly was needed in 57% of men and 49% of women. Following adjuvant treatment, 72% of men maintained surgical remission or achieved normal IGF-1 levels, compared with 89% of women (P = .03). Mean follow-up was shorter in men, 3.6 years, versus 5.2 years for women (P = .02), the researchers reported.

Six-year event-free survival was higher in women (P less than .01), according to the researchers.

For more study findings, watch our video interview.

SOURCE: Handa T et al. AACE 2018. Abstract #824.

BOSTON – Nodules located in the upper pole of the thyroid are more likely to be malignant, according to the results of a retrospective, single-center study presented at the annual meeting of the American Association of Clinical Endocrinologists.

When nodules were located in the upper pole of the gland, the risk of malignancy was about 4 times higher than it was for nodules at other locations in the gland. Researchers confirmed the association using a multiple logistic regression model with adjustment for age, gender, body mass index, laterality, and number of nodules (odds ratio, 4.6; P = 0.03). The findings are believed to be the first to show an association between location of thyroid nodules on ultrasound and malignancy risk.

The results appear to elevate the value of ultrasound for predicting thyroid malignancy and should affect guidelines for ultrasound classification of thyroid nodules, researcher Fan Zhang, MD, PhD, a fellow at State University of New York, Brooklyn, said in a video interview. “In the future, I would recommend maybe we could consider including the location of thyroid nodules in the guidelines for better predictive value of malignancies,” she said.

Other ultrasound characteristics known to be associated with malignancy include findings of microcalcifications, increased vascularity, and nodules that are taller than they are wide, according to Dr. Zhang.

The retrospective review included data on 219 clinic patients with thyroid nodules who underwent fine-needle aspiration biopsy between July 2016 and June 2017. Nearly 80% of the nodules in the review were located in the lower pole of the gland, about 10% were in the upper pole, 7% were in the middle pole, and about 2% were found in the isthmus.

Fourteen nodules, or 7.4%, were found to be malignant, Dr. Zhang and her coauthors said in their presentation. Of those 14 malignancies, 7 were among the 149 nodules in the lower pole, 4 were among the 18 in the upper pole, and 3 were among the 21 in the middle pole.

The anatomy of the thyroid gland may be a factor in why upper pole nodules would be more likely to be associated with malignancy, according to Dr. Zhang. “The veins in the upper lobe are more tortuous compared to in the lower lobe,” she said, noting that slow venous drainage may increase the possibility of developing malignancy.

Dr. Zhang had no relevant disclosures to report.

SOURCE: Zhang F et al. AACE 2018, Abstract 1204.

BOSTON – Nodules located in the upper pole of the thyroid are more likely to be malignant, according to the results of a retrospective, single-center study presented at the annual meeting of the American Association of Clinical Endocrinologists.

When nodules were located in the upper pole of the gland, the risk of malignancy was about 4 times higher than it was for nodules at other locations in the gland. Researchers confirmed the association using a multiple logistic regression model with adjustment for age, gender, body mass index, laterality, and number of nodules (odds ratio, 4.6; P = 0.03). The findings are believed to be the first to show an association between location of thyroid nodules on ultrasound and malignancy risk.

The results appear to elevate the value of ultrasound for predicting thyroid malignancy and should affect guidelines for ultrasound classification of thyroid nodules, researcher Fan Zhang, MD, PhD, a fellow at State University of New York, Brooklyn, said in a video interview. “In the future, I would recommend maybe we could consider including the location of thyroid nodules in the guidelines for better predictive value of malignancies,” she said.

Other ultrasound characteristics known to be associated with malignancy include findings of microcalcifications, increased vascularity, and nodules that are taller than they are wide, according to Dr. Zhang.

The retrospective review included data on 219 clinic patients with thyroid nodules who underwent fine-needle aspiration biopsy between July 2016 and June 2017. Nearly 80% of the nodules in the review were located in the lower pole of the gland, about 10% were in the upper pole, 7% were in the middle pole, and about 2% were found in the isthmus.

Fourteen nodules, or 7.4%, were found to be malignant, Dr. Zhang and her coauthors said in their presentation. Of those 14 malignancies, 7 were among the 149 nodules in the lower pole, 4 were among the 18 in the upper pole, and 3 were among the 21 in the middle pole.

The anatomy of the thyroid gland may be a factor in why upper pole nodules would be more likely to be associated with malignancy, according to Dr. Zhang. “The veins in the upper lobe are more tortuous compared to in the lower lobe,” she said, noting that slow venous drainage may increase the possibility of developing malignancy.

Dr. Zhang had no relevant disclosures to report.

SOURCE: Zhang F et al. AACE 2018, Abstract 1204.

BOSTON – Nodules located in the upper pole of the thyroid are more likely to be malignant, according to the results of a retrospective, single-center study presented at the annual meeting of the American Association of Clinical Endocrinologists.

When nodules were located in the upper pole of the gland, the risk of malignancy was about 4 times higher than it was for nodules at other locations in the gland. Researchers confirmed the association using a multiple logistic regression model with adjustment for age, gender, body mass index, laterality, and number of nodules (odds ratio, 4.6; P = 0.03). The findings are believed to be the first to show an association between location of thyroid nodules on ultrasound and malignancy risk.

The results appear to elevate the value of ultrasound for predicting thyroid malignancy and should affect guidelines for ultrasound classification of thyroid nodules, researcher Fan Zhang, MD, PhD, a fellow at State University of New York, Brooklyn, said in a video interview. “In the future, I would recommend maybe we could consider including the location of thyroid nodules in the guidelines for better predictive value of malignancies,” she said.

Other ultrasound characteristics known to be associated with malignancy include findings of microcalcifications, increased vascularity, and nodules that are taller than they are wide, according to Dr. Zhang.

The retrospective review included data on 219 clinic patients with thyroid nodules who underwent fine-needle aspiration biopsy between July 2016 and June 2017. Nearly 80% of the nodules in the review were located in the lower pole of the gland, about 10% were in the upper pole, 7% were in the middle pole, and about 2% were found in the isthmus.

Fourteen nodules, or 7.4%, were found to be malignant, Dr. Zhang and her coauthors said in their presentation. Of those 14 malignancies, 7 were among the 149 nodules in the lower pole, 4 were among the 18 in the upper pole, and 3 were among the 21 in the middle pole.

The anatomy of the thyroid gland may be a factor in why upper pole nodules would be more likely to be associated with malignancy, according to Dr. Zhang. “The veins in the upper lobe are more tortuous compared to in the lower lobe,” she said, noting that slow venous drainage may increase the possibility of developing malignancy.

Dr. Zhang had no relevant disclosures to report.

SOURCE: Zhang F et al. AACE 2018, Abstract 1204.

BOSTON – It’s time to move beyond body mass index and think about obesity as a chronic disease with complications that may need medical therapy, W. Timothy Garvey, MD, said.

“The term ‘obesity’ means so many things to different people,” Dr. Garvey explained in a video interview at the annual meeting of the American Association of Clinical Endocrinologists. “It doesn’t tell you what the impact is of excess adiposity on health.”

In fact, obesity meets the criteria needed to be defined as a disease, said Dr. Garvey, who coauthored a 2017 AACE position statement recommending a new diagnostic term for obesity: adiposity-based chronic disease, or ABCD.

“It’s not going to replace the general use of the term ‘obesity,’ of course; but for medical diagnosis, this term does tell you what we’re treating, and why we’re treating it,” noted Dr. Garvey, of the University of Alabama at Birmingham.

Instead of relying on BMI [body mass index], the ABCD model emphasizes a “complications-centric” approach that drives therapeutic decisions, which may include medication.

“A structured lifestyle intervention is the key to therapy, but if we add medications on to any lifestyle intervention, we’re going to get more bang for the buck,” Dr. Garvey explained.

“We’re going to get more weight loss and be able to keep it off for a longer period of time,” he added. “We want that in situations in particular where the patient really has complications. This could be diabetes, it could be prediabetes, it could be obstructive sleep apnea, symptomatic osteoarthritis in the knees, stress incontinence, hypertension – any one of a number of weight-related complications that are really impairing health.”

BOSTON – It’s time to move beyond body mass index and think about obesity as a chronic disease with complications that may need medical therapy, W. Timothy Garvey, MD, said.

“The term ‘obesity’ means so many things to different people,” Dr. Garvey explained in a video interview at the annual meeting of the American Association of Clinical Endocrinologists. “It doesn’t tell you what the impact is of excess adiposity on health.”

In fact, obesity meets the criteria needed to be defined as a disease, said Dr. Garvey, who coauthored a 2017 AACE position statement recommending a new diagnostic term for obesity: adiposity-based chronic disease, or ABCD.

“It’s not going to replace the general use of the term ‘obesity,’ of course; but for medical diagnosis, this term does tell you what we’re treating, and why we’re treating it,” noted Dr. Garvey, of the University of Alabama at Birmingham.

Instead of relying on BMI [body mass index], the ABCD model emphasizes a “complications-centric” approach that drives therapeutic decisions, which may include medication.

“A structured lifestyle intervention is the key to therapy, but if we add medications on to any lifestyle intervention, we’re going to get more bang for the buck,” Dr. Garvey explained.

“We’re going to get more weight loss and be able to keep it off for a longer period of time,” he added. “We want that in situations in particular where the patient really has complications. This could be diabetes, it could be prediabetes, it could be obstructive sleep apnea, symptomatic osteoarthritis in the knees, stress incontinence, hypertension – any one of a number of weight-related complications that are really impairing health.”

BOSTON – It’s time to move beyond body mass index and think about obesity as a chronic disease with complications that may need medical therapy, W. Timothy Garvey, MD, said.

“The term ‘obesity’ means so many things to different people,” Dr. Garvey explained in a video interview at the annual meeting of the American Association of Clinical Endocrinologists. “It doesn’t tell you what the impact is of excess adiposity on health.”

In fact, obesity meets the criteria needed to be defined as a disease, said Dr. Garvey, who coauthored a 2017 AACE position statement recommending a new diagnostic term for obesity: adiposity-based chronic disease, or ABCD.

“It’s not going to replace the general use of the term ‘obesity,’ of course; but for medical diagnosis, this term does tell you what we’re treating, and why we’re treating it,” noted Dr. Garvey, of the University of Alabama at Birmingham.

Instead of relying on BMI [body mass index], the ABCD model emphasizes a “complications-centric” approach that drives therapeutic decisions, which may include medication.

“A structured lifestyle intervention is the key to therapy, but if we add medications on to any lifestyle intervention, we’re going to get more bang for the buck,” Dr. Garvey explained.

“We’re going to get more weight loss and be able to keep it off for a longer period of time,” he added. “We want that in situations in particular where the patient really has complications. This could be diabetes, it could be prediabetes, it could be obstructive sleep apnea, symptomatic osteoarthritis in the knees, stress incontinence, hypertension – any one of a number of weight-related complications that are really impairing health.”

SANDESTIN, FLA. – Activated microglia may be a root cause of fibromyalgia, and bringing them back to a resting state an effective path to symptom relief.

Jarred Younger, PhD, is particularly interested in dextronaltrexone, the right-handed isomer of the drug commonly employed in addiction medicine, for calming microglia in fibromyalgia.

Unlike the commercially available levo-naltrexone, which binds at both the mu-opioid receptor and Toll-like receptor 4 (TLR4), dextronaltrexone blocks only TLR4. Blocking this receptor interferes with the cells’ ability to recruit peripheral immune cells, which may enter the brain, release cytokines, and induce a proinflammatory environment. By targeting only TLR4 and sparing opioid receptors, treating fibromyalgia with dextronaltrexone would potentially leave open the possibility of coadministration with an opioid, Dr. Younger said in a video interview at the annual Congress of Clinical Rheumatology.

He already has investigated low-dose levo-naltrexone in a small positive crossover trial in 31 fibromyalgia patients. While taking the drug, patients reported significantly less pain and improved mood.

Dr. Younger also recently published a study suggesting that low-dose naltrexone actively improves peripheral proinflammatory cytokine levels.

The placebo-controlled crossover trial enrolled eight women with moderately severe fibromyalgia who took 4.5 mg naltrexone daily for 8 weeks. Compared with baseline, they had significantly reduced plasma levels of a variety of interleukin (IL) subtypes. Also reduced were interferon-alpha, transforming growth factor-alpha and -beta, TNF-alpha, and granulocyte-colony stimulating factor. Patients experienced a mean 15% reduction in fibromyalgia pain and an 18% reduction in overall symptoms.

But proving the drug’s method of action continues to be a challenge, he admitted. It’s not easy to observe microglial trafficking and cellular response to immune signaling in the brain.

[email protected]

SANDESTIN, FLA. – Activated microglia may be a root cause of fibromyalgia, and bringing them back to a resting state an effective path to symptom relief.

Jarred Younger, PhD, is particularly interested in dextronaltrexone, the right-handed isomer of the drug commonly employed in addiction medicine, for calming microglia in fibromyalgia.

Unlike the commercially available levo-naltrexone, which binds at both the mu-opioid receptor and Toll-like receptor 4 (TLR4), dextronaltrexone blocks only TLR4. Blocking this receptor interferes with the cells’ ability to recruit peripheral immune cells, which may enter the brain, release cytokines, and induce a proinflammatory environment. By targeting only TLR4 and sparing opioid receptors, treating fibromyalgia with dextronaltrexone would potentially leave open the possibility of coadministration with an opioid, Dr. Younger said in a video interview at the annual Congress of Clinical Rheumatology.

He already has investigated low-dose levo-naltrexone in a small positive crossover trial in 31 fibromyalgia patients. While taking the drug, patients reported significantly less pain and improved mood.

Dr. Younger also recently published a study suggesting that low-dose naltrexone actively improves peripheral proinflammatory cytokine levels.

The placebo-controlled crossover trial enrolled eight women with moderately severe fibromyalgia who took 4.5 mg naltrexone daily for 8 weeks. Compared with baseline, they had significantly reduced plasma levels of a variety of interleukin (IL) subtypes. Also reduced were interferon-alpha, transforming growth factor-alpha and -beta, TNF-alpha, and granulocyte-colony stimulating factor. Patients experienced a mean 15% reduction in fibromyalgia pain and an 18% reduction in overall symptoms.

But proving the drug’s method of action continues to be a challenge, he admitted. It’s not easy to observe microglial trafficking and cellular response to immune signaling in the brain.

[email protected]

SANDESTIN, FLA. – Activated microglia may be a root cause of fibromyalgia, and bringing them back to a resting state an effective path to symptom relief.

Jarred Younger, PhD, is particularly interested in dextronaltrexone, the right-handed isomer of the drug commonly employed in addiction medicine, for calming microglia in fibromyalgia.

Unlike the commercially available levo-naltrexone, which binds at both the mu-opioid receptor and Toll-like receptor 4 (TLR4), dextronaltrexone blocks only TLR4. Blocking this receptor interferes with the cells’ ability to recruit peripheral immune cells, which may enter the brain, release cytokines, and induce a proinflammatory environment. By targeting only TLR4 and sparing opioid receptors, treating fibromyalgia with dextronaltrexone would potentially leave open the possibility of coadministration with an opioid, Dr. Younger said in a video interview at the annual Congress of Clinical Rheumatology.

He already has investigated low-dose levo-naltrexone in a small positive crossover trial in 31 fibromyalgia patients. While taking the drug, patients reported significantly less pain and improved mood.

Dr. Younger also recently published a study suggesting that low-dose naltrexone actively improves peripheral proinflammatory cytokine levels.

The placebo-controlled crossover trial enrolled eight women with moderately severe fibromyalgia who took 4.5 mg naltrexone daily for 8 weeks. Compared with baseline, they had significantly reduced plasma levels of a variety of interleukin (IL) subtypes. Also reduced were interferon-alpha, transforming growth factor-alpha and -beta, TNF-alpha, and granulocyte-colony stimulating factor. Patients experienced a mean 15% reduction in fibromyalgia pain and an 18% reduction in overall symptoms.

But proving the drug’s method of action continues to be a challenge, he admitted. It’s not easy to observe microglial trafficking and cellular response to immune signaling in the brain.

[email protected]

SANDESTIN, FLA. – An array of potential new options for psoriatic arthritis offers new targeted options and poses challenges for how to use the drugs, Arthur Kavanaugh, MD, professor of medicine at the University of California, San Diego, said in a video interview at the annual Congress of Clinical Rheumatology.

“We’re seeing a second wave – a second wave driven by the additional ways that we have to target aspects of the immune system relevant to psoriatic arthritis,” he said.

First used to treat rheumatoid arthritis, monoclonal antibodies to interleukin targets, including IL12 and IL23 (ustekinumab) and IL17 (secukinumab and ixekizumab), have become established psoriatic arthritis therapies. Additionally, the Janus kinase (JAK) inhibitor tofacitinib has become an option.

Other options in the pipeline include the JAK inhibitor baricitinib; the anti-IL23 monoclonal antibodies guselkumab, risankizumab, and tildrakizumab; and even more anti-IL17 therapies, including brodalumab and bimekizumab .

“Now we have the synergy of having novel therapeutic approaches to maybe address some of the different domains of disease,” he said. Despite efforts to develop better biomarkers, it’s hard to predict how an individual patient will respond to a specific therapy. The longer the menu of therapeutic options, the better it is for patients.

As methotrexate remains a go-to treatment for many patients, new data from the SEAM trial assessing etanercept and methotrexate will address the question of whether the conventional drug and tumor necrosis factor inhibitors create therapeutic synergy in patients with psoriatic arthritis.

Dr. Kavanaugh discussed the implications of the trial’s findings, which are expected to go public this summer.

SANDESTIN, FLA. – An array of potential new options for psoriatic arthritis offers new targeted options and poses challenges for how to use the drugs, Arthur Kavanaugh, MD, professor of medicine at the University of California, San Diego, said in a video interview at the annual Congress of Clinical Rheumatology.

“We’re seeing a second wave – a second wave driven by the additional ways that we have to target aspects of the immune system relevant to psoriatic arthritis,” he said.

First used to treat rheumatoid arthritis, monoclonal antibodies to interleukin targets, including IL12 and IL23 (ustekinumab) and IL17 (secukinumab and ixekizumab), have become established psoriatic arthritis therapies. Additionally, the Janus kinase (JAK) inhibitor tofacitinib has become an option.

Other options in the pipeline include the JAK inhibitor baricitinib; the anti-IL23 monoclonal antibodies guselkumab, risankizumab, and tildrakizumab; and even more anti-IL17 therapies, including brodalumab and bimekizumab .

“Now we have the synergy of having novel therapeutic approaches to maybe address some of the different domains of disease,” he said. Despite efforts to develop better biomarkers, it’s hard to predict how an individual patient will respond to a specific therapy. The longer the menu of therapeutic options, the better it is for patients.

As methotrexate remains a go-to treatment for many patients, new data from the SEAM trial assessing etanercept and methotrexate will address the question of whether the conventional drug and tumor necrosis factor inhibitors create therapeutic synergy in patients with psoriatic arthritis.

Dr. Kavanaugh discussed the implications of the trial’s findings, which are expected to go public this summer.

SANDESTIN, FLA. – An array of potential new options for psoriatic arthritis offers new targeted options and poses challenges for how to use the drugs, Arthur Kavanaugh, MD, professor of medicine at the University of California, San Diego, said in a video interview at the annual Congress of Clinical Rheumatology.

“We’re seeing a second wave – a second wave driven by the additional ways that we have to target aspects of the immune system relevant to psoriatic arthritis,” he said.

First used to treat rheumatoid arthritis, monoclonal antibodies to interleukin targets, including IL12 and IL23 (ustekinumab) and IL17 (secukinumab and ixekizumab), have become established psoriatic arthritis therapies. Additionally, the Janus kinase (JAK) inhibitor tofacitinib has become an option.

Other options in the pipeline include the JAK inhibitor baricitinib; the anti-IL23 monoclonal antibodies guselkumab, risankizumab, and tildrakizumab; and even more anti-IL17 therapies, including brodalumab and bimekizumab .

“Now we have the synergy of having novel therapeutic approaches to maybe address some of the different domains of disease,” he said. Despite efforts to develop better biomarkers, it’s hard to predict how an individual patient will respond to a specific therapy. The longer the menu of therapeutic options, the better it is for patients.

As methotrexate remains a go-to treatment for many patients, new data from the SEAM trial assessing etanercept and methotrexate will address the question of whether the conventional drug and tumor necrosis factor inhibitors create therapeutic synergy in patients with psoriatic arthritis.

Dr. Kavanaugh discussed the implications of the trial’s findings, which are expected to go public this summer.

BOSTON – The PCSK9 inhibitor alirocumab was superior to ezetimibe in meeting multiple lipid goals In patients with type 2 diabetes, according to results from a pooled analysis of randomized clinical trials.

“Alirocumab is an efficient therapy to get patients at target, which is our clinical daily business and the reason to treat patients,” said investigator Dirk Müller-Wieland, MD, an internist at University Hospital Aachen, Germany.

Dr. Müller-Wieland and his colleagues conducted a pooled analysis of 407 individuals with type 2 diabetes enrolled in one of three randomized trials who had hypercholesterolemia despite background lipid-lowering treatments. They found a total of 241 patients with diabetes who had received alirocumab in the trials, and 166 who had received ezetimibe.

With alirocumab on top of statins, 75.0% of patients met a combined LDL cholesterol, non–HDL cholesterol, and apolipoprotein B threshold after 24 weeks of treatment, compared with 56.7% of patients receiving ezetimibe along with their statins, a significant difference, it was reported at the annual meeting of the American Association of Clinical Endocrinologists.

The proportion of patients achieving LDL levels of less than 70 or 100 mg/dL (depending on cardiovascular risk) was significantly larger in the alirocumab group than in the ezetimibe group, at 80.8% versus 64.3%, Dr. Müller-Wieland reported.

In patients with extreme cardiovascular risk, the proportion of patients achieving LDL levels of less than 55 mg/dL was 66.0% in the alirocumab group, compared with 36.6% in the ezetimibe group, suggesting the PCSK9 inhibitor was “much more efficient than ezetimibe” in reaching that goal, Dr. Müller-Wieland said in a video interview.

For patients in the extreme cardiovascular risk category, as defined in recent guidelines, the AACE recommends a new LDL treatment goal of less than 55 mg/dL, Dr. Müller-Wieland noted.

Significant differences in favor of alirocumab were also reported for the proportion of patients achieving non-HDL and ApoB goals, the report showed.

Adverse events related to treatment occurred in a similar proportion of patients in the alirocumab and ezetimibe groups, according to the investigators.

SOURCE: Müller-Wieland D et al. AACE 2018. Abstract #402.

BOSTON – The PCSK9 inhibitor alirocumab was superior to ezetimibe in meeting multiple lipid goals In patients with type 2 diabetes, according to results from a pooled analysis of randomized clinical trials.

“Alirocumab is an efficient therapy to get patients at target, which is our clinical daily business and the reason to treat patients,” said investigator Dirk Müller-Wieland, MD, an internist at University Hospital Aachen, Germany.

Dr. Müller-Wieland and his colleagues conducted a pooled analysis of 407 individuals with type 2 diabetes enrolled in one of three randomized trials who had hypercholesterolemia despite background lipid-lowering treatments. They found a total of 241 patients with diabetes who had received alirocumab in the trials, and 166 who had received ezetimibe.

With alirocumab on top of statins, 75.0% of patients met a combined LDL cholesterol, non–HDL cholesterol, and apolipoprotein B threshold after 24 weeks of treatment, compared with 56.7% of patients receiving ezetimibe along with their statins, a significant difference, it was reported at the annual meeting of the American Association of Clinical Endocrinologists.

The proportion of patients achieving LDL levels of less than 70 or 100 mg/dL (depending on cardiovascular risk) was significantly larger in the alirocumab group than in the ezetimibe group, at 80.8% versus 64.3%, Dr. Müller-Wieland reported.

In patients with extreme cardiovascular risk, the proportion of patients achieving LDL levels of less than 55 mg/dL was 66.0% in the alirocumab group, compared with 36.6% in the ezetimibe group, suggesting the PCSK9 inhibitor was “much more efficient than ezetimibe” in reaching that goal, Dr. Müller-Wieland said in a video interview.

For patients in the extreme cardiovascular risk category, as defined in recent guidelines, the AACE recommends a new LDL treatment goal of less than 55 mg/dL, Dr. Müller-Wieland noted.

Significant differences in favor of alirocumab were also reported for the proportion of patients achieving non-HDL and ApoB goals, the report showed.

Adverse events related to treatment occurred in a similar proportion of patients in the alirocumab and ezetimibe groups, according to the investigators.

SOURCE: Müller-Wieland D et al. AACE 2018. Abstract #402.

BOSTON – The PCSK9 inhibitor alirocumab was superior to ezetimibe in meeting multiple lipid goals In patients with type 2 diabetes, according to results from a pooled analysis of randomized clinical trials.

“Alirocumab is an efficient therapy to get patients at target, which is our clinical daily business and the reason to treat patients,” said investigator Dirk Müller-Wieland, MD, an internist at University Hospital Aachen, Germany.

Dr. Müller-Wieland and his colleagues conducted a pooled analysis of 407 individuals with type 2 diabetes enrolled in one of three randomized trials who had hypercholesterolemia despite background lipid-lowering treatments. They found a total of 241 patients with diabetes who had received alirocumab in the trials, and 166 who had received ezetimibe.

With alirocumab on top of statins, 75.0% of patients met a combined LDL cholesterol, non–HDL cholesterol, and apolipoprotein B threshold after 24 weeks of treatment, compared with 56.7% of patients receiving ezetimibe along with their statins, a significant difference, it was reported at the annual meeting of the American Association of Clinical Endocrinologists.

The proportion of patients achieving LDL levels of less than 70 or 100 mg/dL (depending on cardiovascular risk) was significantly larger in the alirocumab group than in the ezetimibe group, at 80.8% versus 64.3%, Dr. Müller-Wieland reported.

In patients with extreme cardiovascular risk, the proportion of patients achieving LDL levels of less than 55 mg/dL was 66.0% in the alirocumab group, compared with 36.6% in the ezetimibe group, suggesting the PCSK9 inhibitor was “much more efficient than ezetimibe” in reaching that goal, Dr. Müller-Wieland said in a video interview.

For patients in the extreme cardiovascular risk category, as defined in recent guidelines, the AACE recommends a new LDL treatment goal of less than 55 mg/dL, Dr. Müller-Wieland noted.

Significant differences in favor of alirocumab were also reported for the proportion of patients achieving non-HDL and ApoB goals, the report showed.

Adverse events related to treatment occurred in a similar proportion of patients in the alirocumab and ezetimibe groups, according to the investigators.

SOURCE: Müller-Wieland D et al. AACE 2018. Abstract #402.

SANDESTIN, FLA. – More than ever, clinicians need to rely on a multimodal approach to pain management, Katherine Galluzzi, DO, said at the annual Congress of Clinical Rheumatology.

In the era of opioid addiction – in which she said physicians have sometimes been unfairly vilified – pharmaceutical options are limited not only by the threat of abuse but also by governmental regulation, explained Dr. Galluzzi, chair of geriatrics at the Philadelphia College of Osteopathic Medicine.

The underpinning of pain management in the future will need to be cognitive-behavioral therapy, such as changing behavior and meditation; physical approaches, such as exercise and acupuncture; and interventional treatments, such as nerve blocks and trigger-point injections. Pharmacotherapy can’t do it all, nor should it, she said.

“This is what we have, this is what we need to do,” Dr. Galluzzi said. “This impacts the quality of life, and patients need to begin providing self-care. It’s not going to come in the form of a pill. It has to be a commitment between the patient and the physician.”

The Centers for Medicare & Medicaid Services are proposing a new limit on opioid prescriptions for Medicare recipients – a maximum of 90 morphine mg equivalents per day for no more than 7 days. That will affect older people, who are most likely to be in need of pain management, she said. Those on hospice care and experiencing certain cancer pain will be exempt, she noted in an interview.

Concerns about addiction to drugs such as gabapentin and benzodiazepines might make these therapies less of an option in coming years, Dr. Galluzzi added.

Risk evaluation and mitigation strategy training is an important tool for helping physicians weigh the benefits and the risks of opioid prescriptions. Dr. Galluzzi particularly suggests enrolling in a 3-4 hour, in-person program, saying that it’s well worth the time.

“If you haven’t done a risk assessment and mitigation strategies course and you’re an opioid prescriber,” she said, “I highly recommend that you do that.”

SANDESTIN, FLA. – More than ever, clinicians need to rely on a multimodal approach to pain management, Katherine Galluzzi, DO, said at the annual Congress of Clinical Rheumatology.

In the era of opioid addiction – in which she said physicians have sometimes been unfairly vilified – pharmaceutical options are limited not only by the threat of abuse but also by governmental regulation, explained Dr. Galluzzi, chair of geriatrics at the Philadelphia College of Osteopathic Medicine.

The underpinning of pain management in the future will need to be cognitive-behavioral therapy, such as changing behavior and meditation; physical approaches, such as exercise and acupuncture; and interventional treatments, such as nerve blocks and trigger-point injections. Pharmacotherapy can’t do it all, nor should it, she said.

“This is what we have, this is what we need to do,” Dr. Galluzzi said. “This impacts the quality of life, and patients need to begin providing self-care. It’s not going to come in the form of a pill. It has to be a commitment between the patient and the physician.”

The Centers for Medicare & Medicaid Services are proposing a new limit on opioid prescriptions for Medicare recipients – a maximum of 90 morphine mg equivalents per day for no more than 7 days. That will affect older people, who are most likely to be in need of pain management, she said. Those on hospice care and experiencing certain cancer pain will be exempt, she noted in an interview.

Concerns about addiction to drugs such as gabapentin and benzodiazepines might make these therapies less of an option in coming years, Dr. Galluzzi added.

Risk evaluation and mitigation strategy training is an important tool for helping physicians weigh the benefits and the risks of opioid prescriptions. Dr. Galluzzi particularly suggests enrolling in a 3-4 hour, in-person program, saying that it’s well worth the time.

“If you haven’t done a risk assessment and mitigation strategies course and you’re an opioid prescriber,” she said, “I highly recommend that you do that.”

SANDESTIN, FLA. – More than ever, clinicians need to rely on a multimodal approach to pain management, Katherine Galluzzi, DO, said at the annual Congress of Clinical Rheumatology.

In the era of opioid addiction – in which she said physicians have sometimes been unfairly vilified – pharmaceutical options are limited not only by the threat of abuse but also by governmental regulation, explained Dr. Galluzzi, chair of geriatrics at the Philadelphia College of Osteopathic Medicine.

The underpinning of pain management in the future will need to be cognitive-behavioral therapy, such as changing behavior and meditation; physical approaches, such as exercise and acupuncture; and interventional treatments, such as nerve blocks and trigger-point injections. Pharmacotherapy can’t do it all, nor should it, she said.

“This is what we have, this is what we need to do,” Dr. Galluzzi said. “This impacts the quality of life, and patients need to begin providing self-care. It’s not going to come in the form of a pill. It has to be a commitment between the patient and the physician.”

The Centers for Medicare & Medicaid Services are proposing a new limit on opioid prescriptions for Medicare recipients – a maximum of 90 morphine mg equivalents per day for no more than 7 days. That will affect older people, who are most likely to be in need of pain management, she said. Those on hospice care and experiencing certain cancer pain will be exempt, she noted in an interview.

Concerns about addiction to drugs such as gabapentin and benzodiazepines might make these therapies less of an option in coming years, Dr. Galluzzi added.

Risk evaluation and mitigation strategy training is an important tool for helping physicians weigh the benefits and the risks of opioid prescriptions. Dr. Galluzzi particularly suggests enrolling in a 3-4 hour, in-person program, saying that it’s well worth the time.

“If you haven’t done a risk assessment and mitigation strategies course and you’re an opioid prescriber,” she said, “I highly recommend that you do that.”

SANDESTIN, FLA. – Scleroderma patients appear to have a characteristic microbiome composition, which is consistent in samples taken around the world.

These patients showed decreased populations of beneficial commensal flora and increased populations of proinflammatory species, Elizabeth Volkmann, MD, said at the annual Congress of Clinical Rheumatology.

Furthermore, specific species seem to correlate with specific gastrointestinal symptoms, said Dr. Volkmann of the University of California, Los Angeles. “Features also unexpectedly overlap with the consortium typical for Crohn’s disease, a disease with both inflammatory and fibrosing phenotype,” she said.

Her recent exploration of this topic included 17 patients with scleroderma and GI symptoms and 17 matched healthy controls (BMJ Open Gastro. 2017;3:e000134). Everyone underwent a bowel prep and colonoscopy, during which cecum and sigmoid mucosal lavage samples were obtained. Those samples underwent RNA sequencing.

In addition to quantifying the species present, Dr. Volkmann sought to associate populations with symptoms. The primary assessment tool was the GIT 2.0, which measures distention/bloating; diarrhea; fecal soilage; constipation; emotional well-being; and social functioning.

Similar to the findings in inflammatory disease states, scleroderma patients had decreased levels of commensal Clostridia, a class of Firmicutes that is established in early infancy and very important in the maintenance of gut homeostasis. They also showed a decreased proportion of Faecalibacterium, a genus with anti-inflammatory activity; this finding has been observed in patients with Crohn’s disease.

[email protected]

SANDESTIN, FLA. – Scleroderma patients appear to have a characteristic microbiome composition, which is consistent in samples taken around the world.

These patients showed decreased populations of beneficial commensal flora and increased populations of proinflammatory species, Elizabeth Volkmann, MD, said at the annual Congress of Clinical Rheumatology.

Furthermore, specific species seem to correlate with specific gastrointestinal symptoms, said Dr. Volkmann of the University of California, Los Angeles. “Features also unexpectedly overlap with the consortium typical for Crohn’s disease, a disease with both inflammatory and fibrosing phenotype,” she said.

Her recent exploration of this topic included 17 patients with scleroderma and GI symptoms and 17 matched healthy controls (BMJ Open Gastro. 2017;3:e000134). Everyone underwent a bowel prep and colonoscopy, during which cecum and sigmoid mucosal lavage samples were obtained. Those samples underwent RNA sequencing.

In addition to quantifying the species present, Dr. Volkmann sought to associate populations with symptoms. The primary assessment tool was the GIT 2.0, which measures distention/bloating; diarrhea; fecal soilage; constipation; emotional well-being; and social functioning.

Similar to the findings in inflammatory disease states, scleroderma patients had decreased levels of commensal Clostridia, a class of Firmicutes that is established in early infancy and very important in the maintenance of gut homeostasis. They also showed a decreased proportion of Faecalibacterium, a genus with anti-inflammatory activity; this finding has been observed in patients with Crohn’s disease.

[email protected]

SANDESTIN, FLA. – Scleroderma patients appear to have a characteristic microbiome composition, which is consistent in samples taken around the world.

These patients showed decreased populations of beneficial commensal flora and increased populations of proinflammatory species, Elizabeth Volkmann, MD, said at the annual Congress of Clinical Rheumatology.

Furthermore, specific species seem to correlate with specific gastrointestinal symptoms, said Dr. Volkmann of the University of California, Los Angeles. “Features also unexpectedly overlap with the consortium typical for Crohn’s disease, a disease with both inflammatory and fibrosing phenotype,” she said.

Her recent exploration of this topic included 17 patients with scleroderma and GI symptoms and 17 matched healthy controls (BMJ Open Gastro. 2017;3:e000134). Everyone underwent a bowel prep and colonoscopy, during which cecum and sigmoid mucosal lavage samples were obtained. Those samples underwent RNA sequencing.

In addition to quantifying the species present, Dr. Volkmann sought to associate populations with symptoms. The primary assessment tool was the GIT 2.0, which measures distention/bloating; diarrhea; fecal soilage; constipation; emotional well-being; and social functioning.

Similar to the findings in inflammatory disease states, scleroderma patients had decreased levels of commensal Clostridia, a class of Firmicutes that is established in early infancy and very important in the maintenance of gut homeostasis. They also showed a decreased proportion of Faecalibacterium, a genus with anti-inflammatory activity; this finding has been observed in patients with Crohn’s disease.

[email protected]