Randy Dotinga

LAS VEGAS – IgA vasculitis has a reputation as an illness of childhood, but rheumatologist Alexandra Villa-Forte, MD, MPH, cautioned colleagues that it can strike adults, too, often in a much more severe form. And, she warned, it’s likely not as rare as physicians assume.

Catalina Matiz, MD

“I believe it’s more common in adults than reported. There’s a huge problem with establishing the right way to make the diagnosis in adults, which is why it is missed,” said Dr. Villa-Forte of the Cleveland Clinic, who spoke at the annual Perspectives in Rheumatic Diseases held by Global Academy for Medical Education.

But even if IgA vasculitis (IV) is diagnosed correctly in adults, there are many questions about how to move forward, she said. “Treatment in adults remains a problem since we don’t have data.”

IV is also known as Henoch-Schönlein purpura, or HSP, and “spring fever” because it often appears in children in the spring following an upper respiratory infection.

The condition causes vasculitis, the swelling of small blood vessels in organs such as the skin, joints, kidneys, and intestines. Leaking blood vessels can cause skin rashes known as purpura.

The estimated ranges of disease are high, with the annual incidence in children estimated at 3-26 per 100,000 and in adults at 0.1-1.8 per 100,000. Dr. Villa-Forte noted that the male-to-female ratio is 1.5, and she said the condition is less common in African Americans.

“In children, this is a disease that is frequently self-limited. Most of them don’t need treatment, and most of them do not relapse,” Dr. Villa-Forte said. “In adults, it’s more resistant to treatment, frequently chronic, and frequently relapsing over the years.”

There are other differences in IV between children and adults. “In children, there is a clear seasonal pattern of disease that is not seen in adults,” she said, and it’s linked to preceding infections.

“In adults, there are multiple causes, and most of the time they’re not identified,” she said.

As for diagnosis, she suggests looking at clinical presentation and whether tissue biopsy shows cutaneous leukocytoclastic vasculitis with IgA deposits. She cautioned that increased serum IgA is seen in about 50% of adult patients, making it an unreliable indicator.

Prognosis is much better for children than adults. According to a 2014 study, 80% of children completely recover, compared with 40% of adults. Persistent hematuria or proteinuria occurs in 30% of children and 60% of adults, respectively, while chronic renal failure occurs in 2% of children and 10% of adults (J Korean Med Sci. 2014 Feb;29[2]:198-203).

It’s possible that the latter number may be higher, with as many as 30% of adults developing chronic kidney disease (CKD), Dr. Villa-Forte said.

An estimated 97% of nephritis develops within the first 6 months of disease onset in adults, she said, “and in adults, the active renal disease can persist for over 20 years.”

Guidelines suggest that patients be monitored for CKD for 6 months after disease onset, but Dr. Villa-Forte said it’s better to monitor them for 12 months.

What about treatment? “The major challenge in adults is the real absence between correlation between initial presentation and long-term renal outcome,” she said. “That makes for a difficult choice in terms of treatment selection.”

Fever and cutaneous lesions above the waist may predict renal involvement, she said, although that isn’t confirmed, and increasing proteinuria is a probable factor predicting progression/complications.

According to Dr. Villa-Forte, the value of early treatment hasn’t been proved. Due to the risk of kidney problems, she said, “we don’t feel like we can just watch patients – that we need to do something. But there’s not good data supporting that.”

Various protocols involving steroids, early plasmapheresis, rituximab (Rituxan), and other drug regimens lack evidence, she said, although use of steroids in early nephritis may be beneficial in adults.

Dr. Villa-Forte had no relevant disclosures.

Global Academy for Medical Education and this news organization are owned by the same parent company.

LAS VEGAS – IgA vasculitis has a reputation as an illness of childhood, but rheumatologist Alexandra Villa-Forte, MD, MPH, cautioned colleagues that it can strike adults, too, often in a much more severe form. And, she warned, it’s likely not as rare as physicians assume.

Catalina Matiz, MD

“I believe it’s more common in adults than reported. There’s a huge problem with establishing the right way to make the diagnosis in adults, which is why it is missed,” said Dr. Villa-Forte of the Cleveland Clinic, who spoke at the annual Perspectives in Rheumatic Diseases held by Global Academy for Medical Education.

But even if IgA vasculitis (IV) is diagnosed correctly in adults, there are many questions about how to move forward, she said. “Treatment in adults remains a problem since we don’t have data.”

IV is also known as Henoch-Schönlein purpura, or HSP, and “spring fever” because it often appears in children in the spring following an upper respiratory infection.

The condition causes vasculitis, the swelling of small blood vessels in organs such as the skin, joints, kidneys, and intestines. Leaking blood vessels can cause skin rashes known as purpura.

The estimated ranges of disease are high, with the annual incidence in children estimated at 3-26 per 100,000 and in adults at 0.1-1.8 per 100,000. Dr. Villa-Forte noted that the male-to-female ratio is 1.5, and she said the condition is less common in African Americans.

“In children, this is a disease that is frequently self-limited. Most of them don’t need treatment, and most of them do not relapse,” Dr. Villa-Forte said. “In adults, it’s more resistant to treatment, frequently chronic, and frequently relapsing over the years.”

There are other differences in IV between children and adults. “In children, there is a clear seasonal pattern of disease that is not seen in adults,” she said, and it’s linked to preceding infections.

“In adults, there are multiple causes, and most of the time they’re not identified,” she said.

As for diagnosis, she suggests looking at clinical presentation and whether tissue biopsy shows cutaneous leukocytoclastic vasculitis with IgA deposits. She cautioned that increased serum IgA is seen in about 50% of adult patients, making it an unreliable indicator.

Prognosis is much better for children than adults. According to a 2014 study, 80% of children completely recover, compared with 40% of adults. Persistent hematuria or proteinuria occurs in 30% of children and 60% of adults, respectively, while chronic renal failure occurs in 2% of children and 10% of adults (J Korean Med Sci. 2014 Feb;29[2]:198-203).

It’s possible that the latter number may be higher, with as many as 30% of adults developing chronic kidney disease (CKD), Dr. Villa-Forte said.

An estimated 97% of nephritis develops within the first 6 months of disease onset in adults, she said, “and in adults, the active renal disease can persist for over 20 years.”

Guidelines suggest that patients be monitored for CKD for 6 months after disease onset, but Dr. Villa-Forte said it’s better to monitor them for 12 months.

What about treatment? “The major challenge in adults is the real absence between correlation between initial presentation and long-term renal outcome,” she said. “That makes for a difficult choice in terms of treatment selection.”

Fever and cutaneous lesions above the waist may predict renal involvement, she said, although that isn’t confirmed, and increasing proteinuria is a probable factor predicting progression/complications.

According to Dr. Villa-Forte, the value of early treatment hasn’t been proved. Due to the risk of kidney problems, she said, “we don’t feel like we can just watch patients – that we need to do something. But there’s not good data supporting that.”

Various protocols involving steroids, early plasmapheresis, rituximab (Rituxan), and other drug regimens lack evidence, she said, although use of steroids in early nephritis may be beneficial in adults.

Dr. Villa-Forte had no relevant disclosures.

Global Academy for Medical Education and this news organization are owned by the same parent company.

LAS VEGAS – IgA vasculitis has a reputation as an illness of childhood, but rheumatologist Alexandra Villa-Forte, MD, MPH, cautioned colleagues that it can strike adults, too, often in a much more severe form. And, she warned, it’s likely not as rare as physicians assume.

Catalina Matiz, MD

“I believe it’s more common in adults than reported. There’s a huge problem with establishing the right way to make the diagnosis in adults, which is why it is missed,” said Dr. Villa-Forte of the Cleveland Clinic, who spoke at the annual Perspectives in Rheumatic Diseases held by Global Academy for Medical Education.

But even if IgA vasculitis (IV) is diagnosed correctly in adults, there are many questions about how to move forward, she said. “Treatment in adults remains a problem since we don’t have data.”

IV is also known as Henoch-Schönlein purpura, or HSP, and “spring fever” because it often appears in children in the spring following an upper respiratory infection.

The condition causes vasculitis, the swelling of small blood vessels in organs such as the skin, joints, kidneys, and intestines. Leaking blood vessels can cause skin rashes known as purpura.

The estimated ranges of disease are high, with the annual incidence in children estimated at 3-26 per 100,000 and in adults at 0.1-1.8 per 100,000. Dr. Villa-Forte noted that the male-to-female ratio is 1.5, and she said the condition is less common in African Americans.

“In children, this is a disease that is frequently self-limited. Most of them don’t need treatment, and most of them do not relapse,” Dr. Villa-Forte said. “In adults, it’s more resistant to treatment, frequently chronic, and frequently relapsing over the years.”

There are other differences in IV between children and adults. “In children, there is a clear seasonal pattern of disease that is not seen in adults,” she said, and it’s linked to preceding infections.

“In adults, there are multiple causes, and most of the time they’re not identified,” she said.

As for diagnosis, she suggests looking at clinical presentation and whether tissue biopsy shows cutaneous leukocytoclastic vasculitis with IgA deposits. She cautioned that increased serum IgA is seen in about 50% of adult patients, making it an unreliable indicator.

Prognosis is much better for children than adults. According to a 2014 study, 80% of children completely recover, compared with 40% of adults. Persistent hematuria or proteinuria occurs in 30% of children and 60% of adults, respectively, while chronic renal failure occurs in 2% of children and 10% of adults (J Korean Med Sci. 2014 Feb;29[2]:198-203).

It’s possible that the latter number may be higher, with as many as 30% of adults developing chronic kidney disease (CKD), Dr. Villa-Forte said.

An estimated 97% of nephritis develops within the first 6 months of disease onset in adults, she said, “and in adults, the active renal disease can persist for over 20 years.”

Guidelines suggest that patients be monitored for CKD for 6 months after disease onset, but Dr. Villa-Forte said it’s better to monitor them for 12 months.

What about treatment? “The major challenge in adults is the real absence between correlation between initial presentation and long-term renal outcome,” she said. “That makes for a difficult choice in terms of treatment selection.”

Fever and cutaneous lesions above the waist may predict renal involvement, she said, although that isn’t confirmed, and increasing proteinuria is a probable factor predicting progression/complications.

According to Dr. Villa-Forte, the value of early treatment hasn’t been proved. Due to the risk of kidney problems, she said, “we don’t feel like we can just watch patients – that we need to do something. But there’s not good data supporting that.”

Various protocols involving steroids, early plasmapheresis, rituximab (Rituxan), and other drug regimens lack evidence, she said, although use of steroids in early nephritis may be beneficial in adults.

Dr. Villa-Forte had no relevant disclosures.

Global Academy for Medical Education and this news organization are owned by the same parent company.

LAS VEGAS – Cleveland Clinic rheumatologist Alexandra Villa-Forte, MD, MPH, has a vivid way of describing the challenge of maintaining remission in granulomatosis with polyangiitis (GPA): She called it “the worst nightmare in the clinic” in a presentation at the annual Perspectives in Rheumatic Diseases.

Dr. Villa-Forte should know. She’s treated more than 700 patients with GPA, also known as Wegener’s granulomatosis, a rare disorder that causes necrotizing vasculitis of small arteries and veins. She advises close monitoring of patients in remission, caution regarding toxicity, pneumonia prophylaxis, and an understanding of the limitations of existing medications.

An estimated 3 in 100,000 people have GPA, which can be fatal if it’s not treated. “All patients with active GPA should receive prednisone with a second agent,” she said at the conference, held by Global Academy for Medical Education. “We know that increasing the prednisone or using it alone will not result in sustained remission at all.”

According to her, new concepts in therapeutic guidance suggest four criteria should determine the specific agents used: Involvement of critical organ systems, severity of clinical manifestations, rate of change (such as rapidly progressing kidney failure), and individual patient factors such as comorbidities.

Patients facing immediate risk to life or organ function should get higher doses of corticosteroids, a cytotoxic agent, and perhaps plasmapheresis, she said.

Induction therapy should last 3-6 months, followed by maintenance therapy that keeps the condition at bay, Dr. Villa-Forte said. But things do not always go according to plan.

“The main challenge that we encounter is that relapses still occur during treatment. The patient could be on appropriate treatment and appropriate doses and they still relapse,” she said. “The second challenge is that patients who come off treatment have a very high rate of relapse.”

Research suggests that up to 70% of patients off medication relapse by 18 months, and 15%-35% of patients on medication relapse by 12-18 months, Dr. Villa-Forte said.

“Every time a patient relapses, it means induction therapy and high doses of prednisone are started all over again,” she said. “Multiple relapses are associated with a very high rate of complications. That’s what we’re trying to avoid through successful maintenance therapy.”

Which agent is best for maintenance? Research has suggested that there’s little difference in relapse rates between methotrexate and azathioprine, while mycophenolate mofetil was linked to more relapses than was azathioprine. Other research has found that rituximab (Rituxan) is superior to azathioprine at sustaining remission and overall survival (N Engl J Med. 2014 Nov 6;371[19]:1771-80).

Questions about rituximab remain, Dr. Villa-Forte said: Can remission be sustained with fewer infusions? Would higher doses produce long-term benefit after therapy is halted without boosting toxicity?

Regardless of the drug used, relapses from remission are still frequent, suggesting the need to focus on special treatment for patients at higher risk for relapse, she said.

For now, she gave these tips about how to treat patients in remission:

• Reduce treatment toxicity (it’s “significant over time and not better with rituximab”) and focus on disease activity and complications.

• Take regular labs and get a fresh urine sediment analysis with every visit. In some cases, the urine analysis in patients who seem healthy will reveal hematuria, a sign of nephritis. Then, “you have to make a decision about changing the treatment just by looking at the urine.”

• Pay attention to the risk of thrombosis.

• Put patients on Pneumocystis carinii pneumonia prophylaxis even if they’re only on a bit of prednisone.

• Be aware of risk factors for relapse, including a history of at least one relapse and stopping therapy before 48 months.

Dr. Villa-Forte had no relevant disclosures.

Global Academy for Medical Education and this news organization are owned by the same parent company.

LAS VEGAS – Cleveland Clinic rheumatologist Alexandra Villa-Forte, MD, MPH, has a vivid way of describing the challenge of maintaining remission in granulomatosis with polyangiitis (GPA): She called it “the worst nightmare in the clinic” in a presentation at the annual Perspectives in Rheumatic Diseases.

Dr. Villa-Forte should know. She’s treated more than 700 patients with GPA, also known as Wegener’s granulomatosis, a rare disorder that causes necrotizing vasculitis of small arteries and veins. She advises close monitoring of patients in remission, caution regarding toxicity, pneumonia prophylaxis, and an understanding of the limitations of existing medications.

An estimated 3 in 100,000 people have GPA, which can be fatal if it’s not treated. “All patients with active GPA should receive prednisone with a second agent,” she said at the conference, held by Global Academy for Medical Education. “We know that increasing the prednisone or using it alone will not result in sustained remission at all.”

According to her, new concepts in therapeutic guidance suggest four criteria should determine the specific agents used: Involvement of critical organ systems, severity of clinical manifestations, rate of change (such as rapidly progressing kidney failure), and individual patient factors such as comorbidities.

Patients facing immediate risk to life or organ function should get higher doses of corticosteroids, a cytotoxic agent, and perhaps plasmapheresis, she said.

Induction therapy should last 3-6 months, followed by maintenance therapy that keeps the condition at bay, Dr. Villa-Forte said. But things do not always go according to plan.

“The main challenge that we encounter is that relapses still occur during treatment. The patient could be on appropriate treatment and appropriate doses and they still relapse,” she said. “The second challenge is that patients who come off treatment have a very high rate of relapse.”

Research suggests that up to 70% of patients off medication relapse by 18 months, and 15%-35% of patients on medication relapse by 12-18 months, Dr. Villa-Forte said.

“Every time a patient relapses, it means induction therapy and high doses of prednisone are started all over again,” she said. “Multiple relapses are associated with a very high rate of complications. That’s what we’re trying to avoid through successful maintenance therapy.”

Which agent is best for maintenance? Research has suggested that there’s little difference in relapse rates between methotrexate and azathioprine, while mycophenolate mofetil was linked to more relapses than was azathioprine. Other research has found that rituximab (Rituxan) is superior to azathioprine at sustaining remission and overall survival (N Engl J Med. 2014 Nov 6;371[19]:1771-80).

Questions about rituximab remain, Dr. Villa-Forte said: Can remission be sustained with fewer infusions? Would higher doses produce long-term benefit after therapy is halted without boosting toxicity?

Regardless of the drug used, relapses from remission are still frequent, suggesting the need to focus on special treatment for patients at higher risk for relapse, she said.

For now, she gave these tips about how to treat patients in remission:

• Reduce treatment toxicity (it’s “significant over time and not better with rituximab”) and focus on disease activity and complications.

• Take regular labs and get a fresh urine sediment analysis with every visit. In some cases, the urine analysis in patients who seem healthy will reveal hematuria, a sign of nephritis. Then, “you have to make a decision about changing the treatment just by looking at the urine.”

• Pay attention to the risk of thrombosis.

• Put patients on Pneumocystis carinii pneumonia prophylaxis even if they’re only on a bit of prednisone.

• Be aware of risk factors for relapse, including a history of at least one relapse and stopping therapy before 48 months.

Dr. Villa-Forte had no relevant disclosures.

Global Academy for Medical Education and this news organization are owned by the same parent company.

LAS VEGAS – Cleveland Clinic rheumatologist Alexandra Villa-Forte, MD, MPH, has a vivid way of describing the challenge of maintaining remission in granulomatosis with polyangiitis (GPA): She called it “the worst nightmare in the clinic” in a presentation at the annual Perspectives in Rheumatic Diseases.

Dr. Villa-Forte should know. She’s treated more than 700 patients with GPA, also known as Wegener’s granulomatosis, a rare disorder that causes necrotizing vasculitis of small arteries and veins. She advises close monitoring of patients in remission, caution regarding toxicity, pneumonia prophylaxis, and an understanding of the limitations of existing medications.

An estimated 3 in 100,000 people have GPA, which can be fatal if it’s not treated. “All patients with active GPA should receive prednisone with a second agent,” she said at the conference, held by Global Academy for Medical Education. “We know that increasing the prednisone or using it alone will not result in sustained remission at all.”

According to her, new concepts in therapeutic guidance suggest four criteria should determine the specific agents used: Involvement of critical organ systems, severity of clinical manifestations, rate of change (such as rapidly progressing kidney failure), and individual patient factors such as comorbidities.

Patients facing immediate risk to life or organ function should get higher doses of corticosteroids, a cytotoxic agent, and perhaps plasmapheresis, she said.

Induction therapy should last 3-6 months, followed by maintenance therapy that keeps the condition at bay, Dr. Villa-Forte said. But things do not always go according to plan.

“The main challenge that we encounter is that relapses still occur during treatment. The patient could be on appropriate treatment and appropriate doses and they still relapse,” she said. “The second challenge is that patients who come off treatment have a very high rate of relapse.”

Research suggests that up to 70% of patients off medication relapse by 18 months, and 15%-35% of patients on medication relapse by 12-18 months, Dr. Villa-Forte said.

“Every time a patient relapses, it means induction therapy and high doses of prednisone are started all over again,” she said. “Multiple relapses are associated with a very high rate of complications. That’s what we’re trying to avoid through successful maintenance therapy.”

Which agent is best for maintenance? Research has suggested that there’s little difference in relapse rates between methotrexate and azathioprine, while mycophenolate mofetil was linked to more relapses than was azathioprine. Other research has found that rituximab (Rituxan) is superior to azathioprine at sustaining remission and overall survival (N Engl J Med. 2014 Nov 6;371[19]:1771-80).

Questions about rituximab remain, Dr. Villa-Forte said: Can remission be sustained with fewer infusions? Would higher doses produce long-term benefit after therapy is halted without boosting toxicity?

Regardless of the drug used, relapses from remission are still frequent, suggesting the need to focus on special treatment for patients at higher risk for relapse, she said.

For now, she gave these tips about how to treat patients in remission:

• Reduce treatment toxicity (it’s “significant over time and not better with rituximab”) and focus on disease activity and complications.

• Take regular labs and get a fresh urine sediment analysis with every visit. In some cases, the urine analysis in patients who seem healthy will reveal hematuria, a sign of nephritis. Then, “you have to make a decision about changing the treatment just by looking at the urine.”

• Pay attention to the risk of thrombosis.

• Put patients on Pneumocystis carinii pneumonia prophylaxis even if they’re only on a bit of prednisone.

• Be aware of risk factors for relapse, including a history of at least one relapse and stopping therapy before 48 months.

Dr. Villa-Forte had no relevant disclosures.

Global Academy for Medical Education and this news organization are owned by the same parent company.

LAS VEGAS – Brian F. Mandell, MD, PhD, of Cleveland Clinic, has a message about one of the most devastating conditions that rheumatologists see: Gout isn’t just a treatable disease. It’s a curable one.

Still, research shows time and time again that physicians manage gout “horrendously,” he told colleagues at the annual Perspectives in Rheumatic Diseases held by Global Academy for Medical Education. “The problem really lies with us,” he said. “We need to do a better job.”

At issue, he believes, is a failure to consider the basic workings of gout when making treatment decisions and advising patients. Lowering serum uric acid (SUA) via medication works, he said, but physicians too frequently don’t go far enough with this approach.

Gout appears to be on the rise in the United States, reflecting increases in related conditions such as obesity and diabetes. A study published this year found that the rate of new-onset gout more than doubled in Olmsted County, Minn., from 1989-1992 to 2009-2010, reaching an adjusted rate of 137/100,000 (J Rheumatol. 2018 Apr;45[4]:574-9).

According to Dr. Mandell, various mysteries regarding gout still need to be cleared up. For one, does resolution of gout also resolve conditions related to hyperuricemia, such as onset of hypertension, progressive chronic kidney disease, and nonalcoholic fatty liver along with higher all-cause mortality?

“We don’t know from interventional studies whether these are as reversible as the gouty arthritis,” he said.

It’s also unknown why so many hyperuricemic patients don’t get flares, with one study estimating that about 50% don’t get them over 15 years (Arthritis Rheumatol. 2017;69[Suppl 10]: Abstract 2843).

One fascinating theory, Dr. Mandell said, suggests “the microbiome is playing a huge [role] in the body’s response to deposits of crystals.”

Fortunately, he said, other mysteries about gout are being solved.

It’s now clear that lowering SUA below 6 mg/dL with medication will reduce flares, Dr. Mandell said. He pointed to a 2017 study of 314 patients with early gout that found 63% of patients who took febuxostat (Uloric) lowered their SUA below 6 mg/dL, compared with just 6% of the placebo group. The overall percentage of patients who had at least one gout flare over 2 years was 29% in the febuxostat group vs. 41% in the placebo group (Arthritis Rheumatol. 2017;69[12]:2386‐95).

It’s also clear that maintenance of lower SUA levels is crucial to prevent recurrence, Dr. Mandell said.

So why is management of hyperuricemia so poor? He ticked off various possible explanations: Maybe it’s the medications. Or perhaps patient compliance is low.

But the drugs are fine, he said, although he cautioned that too-rapid lowering of SUA levels can provoke attacks. He pointed to a 2014 study that suggests allopurinol can help nearly all patients get their SUA below 6 mg/dL, and in the study, the drug was “generally well tolerated” (Semin Arthritis Rheum. 2014 Aug;44[1]:25-30).

As for compliance, Dr. Mandell said, it can be boosted by patient education. The problem, he said, is that physicians are failing patients by not up-titrating allopurinol despite evidence that this approach works.

He added that hyperuricemia can be managed even in patients on diuretic therapy (Arthritis Res Ther. 2018;20:53).

What about patients who are intolerant to allopurinol or don’t fully respond to it on the SUA front? Dr. Mandell said he likes to try febuxostat, although he noted that it’s tremendously more expensive than allopurinol in the United States with a price that could be 10 times higher.

The nonscored design of febuxostat pills makes dose adjustment difficult in patients, he said, and there are concerns about heart-related and all-cause deaths.

Lesinurad (Zurampic) may be helpful for patients with hyperuricemia that doesn’t response to high doses of xanthine oxidase inhibitors (XOI) or if they’re intolerant to lower inadequate doses, he said. Avoid the drug in patients with chronic kidney disease, he cautioned, and be aware that it’s not approved as a monotherapy. Instead, it’s approved by the Food and Drug Administration for use with an XOI.

As for other gout issues, Dr. Mandell said pegloticase (Krystexxa) via infusion can help patients who don’t respond to an XOI but infusion reactions can occur (mainly in nonresponders), and it’s extremely expensive (about $20,000 per month).

He added that anti–IL-1 therapy is effective in hospitalized patients with gout and doesn’t exacerbate other conditions.

Dr. Mandell disclosed various links to drug makers that produce treatments for gout. He has served as clinical investigator for Horizon, has been a consultant to AstraZeneca, Ironwood, and Horizon, and has received honoraria (unrestricted grants) for continuing medical education activities from Takeda and Horizon. He also reported soliciting advertisements for a journal and educational grants for CME activities.

Global Academy for Medical Education and this news organization are owned by the same parent company.

LAS VEGAS – Brian F. Mandell, MD, PhD, of Cleveland Clinic, has a message about one of the most devastating conditions that rheumatologists see: Gout isn’t just a treatable disease. It’s a curable one.

Still, research shows time and time again that physicians manage gout “horrendously,” he told colleagues at the annual Perspectives in Rheumatic Diseases held by Global Academy for Medical Education. “The problem really lies with us,” he said. “We need to do a better job.”

At issue, he believes, is a failure to consider the basic workings of gout when making treatment decisions and advising patients. Lowering serum uric acid (SUA) via medication works, he said, but physicians too frequently don’t go far enough with this approach.

Gout appears to be on the rise in the United States, reflecting increases in related conditions such as obesity and diabetes. A study published this year found that the rate of new-onset gout more than doubled in Olmsted County, Minn., from 1989-1992 to 2009-2010, reaching an adjusted rate of 137/100,000 (J Rheumatol. 2018 Apr;45[4]:574-9).

According to Dr. Mandell, various mysteries regarding gout still need to be cleared up. For one, does resolution of gout also resolve conditions related to hyperuricemia, such as onset of hypertension, progressive chronic kidney disease, and nonalcoholic fatty liver along with higher all-cause mortality?

“We don’t know from interventional studies whether these are as reversible as the gouty arthritis,” he said.

It’s also unknown why so many hyperuricemic patients don’t get flares, with one study estimating that about 50% don’t get them over 15 years (Arthritis Rheumatol. 2017;69[Suppl 10]: Abstract 2843).

One fascinating theory, Dr. Mandell said, suggests “the microbiome is playing a huge [role] in the body’s response to deposits of crystals.”

Fortunately, he said, other mysteries about gout are being solved.

It’s now clear that lowering SUA below 6 mg/dL with medication will reduce flares, Dr. Mandell said. He pointed to a 2017 study of 314 patients with early gout that found 63% of patients who took febuxostat (Uloric) lowered their SUA below 6 mg/dL, compared with just 6% of the placebo group. The overall percentage of patients who had at least one gout flare over 2 years was 29% in the febuxostat group vs. 41% in the placebo group (Arthritis Rheumatol. 2017;69[12]:2386‐95).

It’s also clear that maintenance of lower SUA levels is crucial to prevent recurrence, Dr. Mandell said.

So why is management of hyperuricemia so poor? He ticked off various possible explanations: Maybe it’s the medications. Or perhaps patient compliance is low.

But the drugs are fine, he said, although he cautioned that too-rapid lowering of SUA levels can provoke attacks. He pointed to a 2014 study that suggests allopurinol can help nearly all patients get their SUA below 6 mg/dL, and in the study, the drug was “generally well tolerated” (Semin Arthritis Rheum. 2014 Aug;44[1]:25-30).

As for compliance, Dr. Mandell said, it can be boosted by patient education. The problem, he said, is that physicians are failing patients by not up-titrating allopurinol despite evidence that this approach works.

He added that hyperuricemia can be managed even in patients on diuretic therapy (Arthritis Res Ther. 2018;20:53).

What about patients who are intolerant to allopurinol or don’t fully respond to it on the SUA front? Dr. Mandell said he likes to try febuxostat, although he noted that it’s tremendously more expensive than allopurinol in the United States with a price that could be 10 times higher.

The nonscored design of febuxostat pills makes dose adjustment difficult in patients, he said, and there are concerns about heart-related and all-cause deaths.

Lesinurad (Zurampic) may be helpful for patients with hyperuricemia that doesn’t response to high doses of xanthine oxidase inhibitors (XOI) or if they’re intolerant to lower inadequate doses, he said. Avoid the drug in patients with chronic kidney disease, he cautioned, and be aware that it’s not approved as a monotherapy. Instead, it’s approved by the Food and Drug Administration for use with an XOI.

As for other gout issues, Dr. Mandell said pegloticase (Krystexxa) via infusion can help patients who don’t respond to an XOI but infusion reactions can occur (mainly in nonresponders), and it’s extremely expensive (about $20,000 per month).

He added that anti–IL-1 therapy is effective in hospitalized patients with gout and doesn’t exacerbate other conditions.

Dr. Mandell disclosed various links to drug makers that produce treatments for gout. He has served as clinical investigator for Horizon, has been a consultant to AstraZeneca, Ironwood, and Horizon, and has received honoraria (unrestricted grants) for continuing medical education activities from Takeda and Horizon. He also reported soliciting advertisements for a journal and educational grants for CME activities.

Global Academy for Medical Education and this news organization are owned by the same parent company.

LAS VEGAS – Brian F. Mandell, MD, PhD, of Cleveland Clinic, has a message about one of the most devastating conditions that rheumatologists see: Gout isn’t just a treatable disease. It’s a curable one.

Still, research shows time and time again that physicians manage gout “horrendously,” he told colleagues at the annual Perspectives in Rheumatic Diseases held by Global Academy for Medical Education. “The problem really lies with us,” he said. “We need to do a better job.”

At issue, he believes, is a failure to consider the basic workings of gout when making treatment decisions and advising patients. Lowering serum uric acid (SUA) via medication works, he said, but physicians too frequently don’t go far enough with this approach.

Gout appears to be on the rise in the United States, reflecting increases in related conditions such as obesity and diabetes. A study published this year found that the rate of new-onset gout more than doubled in Olmsted County, Minn., from 1989-1992 to 2009-2010, reaching an adjusted rate of 137/100,000 (J Rheumatol. 2018 Apr;45[4]:574-9).

According to Dr. Mandell, various mysteries regarding gout still need to be cleared up. For one, does resolution of gout also resolve conditions related to hyperuricemia, such as onset of hypertension, progressive chronic kidney disease, and nonalcoholic fatty liver along with higher all-cause mortality?

“We don’t know from interventional studies whether these are as reversible as the gouty arthritis,” he said.

It’s also unknown why so many hyperuricemic patients don’t get flares, with one study estimating that about 50% don’t get them over 15 years (Arthritis Rheumatol. 2017;69[Suppl 10]: Abstract 2843).

One fascinating theory, Dr. Mandell said, suggests “the microbiome is playing a huge [role] in the body’s response to deposits of crystals.”

Fortunately, he said, other mysteries about gout are being solved.

It’s now clear that lowering SUA below 6 mg/dL with medication will reduce flares, Dr. Mandell said. He pointed to a 2017 study of 314 patients with early gout that found 63% of patients who took febuxostat (Uloric) lowered their SUA below 6 mg/dL, compared with just 6% of the placebo group. The overall percentage of patients who had at least one gout flare over 2 years was 29% in the febuxostat group vs. 41% in the placebo group (Arthritis Rheumatol. 2017;69[12]:2386‐95).

It’s also clear that maintenance of lower SUA levels is crucial to prevent recurrence, Dr. Mandell said.

So why is management of hyperuricemia so poor? He ticked off various possible explanations: Maybe it’s the medications. Or perhaps patient compliance is low.

But the drugs are fine, he said, although he cautioned that too-rapid lowering of SUA levels can provoke attacks. He pointed to a 2014 study that suggests allopurinol can help nearly all patients get their SUA below 6 mg/dL, and in the study, the drug was “generally well tolerated” (Semin Arthritis Rheum. 2014 Aug;44[1]:25-30).

As for compliance, Dr. Mandell said, it can be boosted by patient education. The problem, he said, is that physicians are failing patients by not up-titrating allopurinol despite evidence that this approach works.

He added that hyperuricemia can be managed even in patients on diuretic therapy (Arthritis Res Ther. 2018;20:53).

What about patients who are intolerant to allopurinol or don’t fully respond to it on the SUA front? Dr. Mandell said he likes to try febuxostat, although he noted that it’s tremendously more expensive than allopurinol in the United States with a price that could be 10 times higher.

The nonscored design of febuxostat pills makes dose adjustment difficult in patients, he said, and there are concerns about heart-related and all-cause deaths.

Lesinurad (Zurampic) may be helpful for patients with hyperuricemia that doesn’t response to high doses of xanthine oxidase inhibitors (XOI) or if they’re intolerant to lower inadequate doses, he said. Avoid the drug in patients with chronic kidney disease, he cautioned, and be aware that it’s not approved as a monotherapy. Instead, it’s approved by the Food and Drug Administration for use with an XOI.

As for other gout issues, Dr. Mandell said pegloticase (Krystexxa) via infusion can help patients who don’t respond to an XOI but infusion reactions can occur (mainly in nonresponders), and it’s extremely expensive (about $20,000 per month).

He added that anti–IL-1 therapy is effective in hospitalized patients with gout and doesn’t exacerbate other conditions.

Dr. Mandell disclosed various links to drug makers that produce treatments for gout. He has served as clinical investigator for Horizon, has been a consultant to AstraZeneca, Ironwood, and Horizon, and has received honoraria (unrestricted grants) for continuing medical education activities from Takeda and Horizon. He also reported soliciting advertisements for a journal and educational grants for CME activities.

Global Academy for Medical Education and this news organization are owned by the same parent company.

A new study finds that piperacillin-tazobactam doesn’t improve mortality compared to meropenem in patients with ceftriaxone-resistant blood poisoning caused by E. coli or K. pneumoniae. The findings were so striking that the study was ended early.

Vidyard Video

Courtesy: JAMA

“These findings do not support use of piperacillin-tazobactam in this setting,” wrote the authors. The report was published Sept. 11 in JAMA (2018;320[10]:984-94.)

According to the Centers for Disease Control and Prevention, an estimated 1,700 deaths in the United States in 2011 were caused by gram-negative bacteria that produce extended-spectrum beta-lactamase enzymes.

While carbapenems such as meropenem (Merrem) are “regarded as the treatment of choice for serious infections,” the MERINO trial (NCT02176122) authors wrote, their rising use could lead to drug resistance.

One alternate option is to embrace beta-lactam/beta-lactamase inhibitors such as piperacillin-tazobactam (Zosyn), the researchers noted, but research has produced conflicting results.

Piperacillin-tazobactam is an injected penicillin antibiotic used to treat conditions such as severe pneumonia, complicated urinary tract infections and complicated skin and soft tissue infections.

For the new study, researchers led by Patrick N. A. Harris, MBBS, of the University of Queensland, randomly assigned 188 patients to intravenous piperacillin-tazobactam (4.5 g every 6 hours) and 191 patients to meropenem (1 g every 8 hours) for 4-14 days, depending on clinician’s preference. (12 other patients did not continue with the study after initial randomization due to factors such as errors).

All patients were adults and had at least one blood test showing they were positive for E. coli or K. pneumoniae. They all had to be nonsusceptible to ceftriaxone (Rocephin) but susceptible to piperacillin-tazobactam.

The study was ceased prior to enrollment because of the risk of harm. Interim findings suggested the study was unlikely to show higher effectiveness for piperacillin-tazobactam

The primary analysis included 379 patients (mean age 67 years, 48% were women), and the primary outcome analysis included 378 patients.

A total of 23 (12.3%) of 187 patients in the piperacillin-tazobactam group died by 30 days compared to 7 (3.7%) of 191 in the meropenem group (risk difference: 8.6%, P = .90 for noninferiority).

By day 4, 68% of the piperacillin-tazobactam group and 75% of the meropenem group achieved clinical and microbiological resolution.

Serious adverse effects other than death were rare, occurring in around 3% of the piperacillin-tazobactam group and nearly 2% of the meropenem group.

The researchers note various limitations, including the unblinded nature of the study and the fact that it’s not known if extended or continuous infusions of piperacillin-tazobactam would boost the drug’s effectiveness. They also note that delays resulted in some patients initially receiving treatment with one of the study’s two drugs before being randomized to the other.

The study authors caution that it’s not clear if newer beta-lactam/beta-lactamase inhibitors agents such as ceftolozane-tazobactam or ceftazidime-avibactam may be effective in this population.

The study was funded by the University of Queensland, Australian Society for Antimicrobials, International Society for Chemotherapy, and National University Hospital Singapore. Various organizations funded the researchers and the study’s whole-genome sequencing. The study authors report various disclosures, including funding from drugmakers such as Pfizer, maker of Zosyn (through its subsidiary Wyeth) and Merrem.
 

SOURCE: Harris PNA et al. JAMA 2018 Sep 11;320[10]:984-94. doi: 10.1001/jama.2018.12163.

A new study finds that piperacillin-tazobactam doesn’t improve mortality compared to meropenem in patients with ceftriaxone-resistant blood poisoning caused by E. coli or K. pneumoniae. The findings were so striking that the study was ended early.

Vidyard Video

Courtesy: JAMA

“These findings do not support use of piperacillin-tazobactam in this setting,” wrote the authors. The report was published Sept. 11 in JAMA (2018;320[10]:984-94.)

According to the Centers for Disease Control and Prevention, an estimated 1,700 deaths in the United States in 2011 were caused by gram-negative bacteria that produce extended-spectrum beta-lactamase enzymes.

While carbapenems such as meropenem (Merrem) are “regarded as the treatment of choice for serious infections,” the MERINO trial (NCT02176122) authors wrote, their rising use could lead to drug resistance.

One alternate option is to embrace beta-lactam/beta-lactamase inhibitors such as piperacillin-tazobactam (Zosyn), the researchers noted, but research has produced conflicting results.

Piperacillin-tazobactam is an injected penicillin antibiotic used to treat conditions such as severe pneumonia, complicated urinary tract infections and complicated skin and soft tissue infections.

For the new study, researchers led by Patrick N. A. Harris, MBBS, of the University of Queensland, randomly assigned 188 patients to intravenous piperacillin-tazobactam (4.5 g every 6 hours) and 191 patients to meropenem (1 g every 8 hours) for 4-14 days, depending on clinician’s preference. (12 other patients did not continue with the study after initial randomization due to factors such as errors).

All patients were adults and had at least one blood test showing they were positive for E. coli or K. pneumoniae. They all had to be nonsusceptible to ceftriaxone (Rocephin) but susceptible to piperacillin-tazobactam.

The study was ceased prior to enrollment because of the risk of harm. Interim findings suggested the study was unlikely to show higher effectiveness for piperacillin-tazobactam

The primary analysis included 379 patients (mean age 67 years, 48% were women), and the primary outcome analysis included 378 patients.

A total of 23 (12.3%) of 187 patients in the piperacillin-tazobactam group died by 30 days compared to 7 (3.7%) of 191 in the meropenem group (risk difference: 8.6%, P = .90 for noninferiority).

By day 4, 68% of the piperacillin-tazobactam group and 75% of the meropenem group achieved clinical and microbiological resolution.

Serious adverse effects other than death were rare, occurring in around 3% of the piperacillin-tazobactam group and nearly 2% of the meropenem group.

The researchers note various limitations, including the unblinded nature of the study and the fact that it’s not known if extended or continuous infusions of piperacillin-tazobactam would boost the drug’s effectiveness. They also note that delays resulted in some patients initially receiving treatment with one of the study’s two drugs before being randomized to the other.

The study authors caution that it’s not clear if newer beta-lactam/beta-lactamase inhibitors agents such as ceftolozane-tazobactam or ceftazidime-avibactam may be effective in this population.

The study was funded by the University of Queensland, Australian Society for Antimicrobials, International Society for Chemotherapy, and National University Hospital Singapore. Various organizations funded the researchers and the study’s whole-genome sequencing. The study authors report various disclosures, including funding from drugmakers such as Pfizer, maker of Zosyn (through its subsidiary Wyeth) and Merrem.
 

SOURCE: Harris PNA et al. JAMA 2018 Sep 11;320[10]:984-94. doi: 10.1001/jama.2018.12163.

A new study finds that piperacillin-tazobactam doesn’t improve mortality compared to meropenem in patients with ceftriaxone-resistant blood poisoning caused by E. coli or K. pneumoniae. The findings were so striking that the study was ended early.

Vidyard Video

Courtesy: JAMA

“These findings do not support use of piperacillin-tazobactam in this setting,” wrote the authors. The report was published Sept. 11 in JAMA (2018;320[10]:984-94.)

According to the Centers for Disease Control and Prevention, an estimated 1,700 deaths in the United States in 2011 were caused by gram-negative bacteria that produce extended-spectrum beta-lactamase enzymes.

While carbapenems such as meropenem (Merrem) are “regarded as the treatment of choice for serious infections,” the MERINO trial (NCT02176122) authors wrote, their rising use could lead to drug resistance.

One alternate option is to embrace beta-lactam/beta-lactamase inhibitors such as piperacillin-tazobactam (Zosyn), the researchers noted, but research has produced conflicting results.

Piperacillin-tazobactam is an injected penicillin antibiotic used to treat conditions such as severe pneumonia, complicated urinary tract infections and complicated skin and soft tissue infections.

For the new study, researchers led by Patrick N. A. Harris, MBBS, of the University of Queensland, randomly assigned 188 patients to intravenous piperacillin-tazobactam (4.5 g every 6 hours) and 191 patients to meropenem (1 g every 8 hours) for 4-14 days, depending on clinician’s preference. (12 other patients did not continue with the study after initial randomization due to factors such as errors).

All patients were adults and had at least one blood test showing they were positive for E. coli or K. pneumoniae. They all had to be nonsusceptible to ceftriaxone (Rocephin) but susceptible to piperacillin-tazobactam.

The study was ceased prior to enrollment because of the risk of harm. Interim findings suggested the study was unlikely to show higher effectiveness for piperacillin-tazobactam

The primary analysis included 379 patients (mean age 67 years, 48% were women), and the primary outcome analysis included 378 patients.

A total of 23 (12.3%) of 187 patients in the piperacillin-tazobactam group died by 30 days compared to 7 (3.7%) of 191 in the meropenem group (risk difference: 8.6%, P = .90 for noninferiority).

By day 4, 68% of the piperacillin-tazobactam group and 75% of the meropenem group achieved clinical and microbiological resolution.

Serious adverse effects other than death were rare, occurring in around 3% of the piperacillin-tazobactam group and nearly 2% of the meropenem group.

The researchers note various limitations, including the unblinded nature of the study and the fact that it’s not known if extended or continuous infusions of piperacillin-tazobactam would boost the drug’s effectiveness. They also note that delays resulted in some patients initially receiving treatment with one of the study’s two drugs before being randomized to the other.

The study authors caution that it’s not clear if newer beta-lactam/beta-lactamase inhibitors agents such as ceftolozane-tazobactam or ceftazidime-avibactam may be effective in this population.

The study was funded by the University of Queensland, Australian Society for Antimicrobials, International Society for Chemotherapy, and National University Hospital Singapore. Various organizations funded the researchers and the study’s whole-genome sequencing. The study authors report various disclosures, including funding from drugmakers such as Pfizer, maker of Zosyn (through its subsidiary Wyeth) and Merrem.
 

SOURCE: Harris PNA et al. JAMA 2018 Sep 11;320[10]:984-94. doi: 10.1001/jama.2018.12163.

A new study offers insight into the development of atopic dermatitis (AD) by linking the severity of the disease to colonization by different Staphylococcus aureus clonal complex (CC) types over time.

The research “suggests that different CC types might harbor different virulence factors and that the patient’s immune system needs to adjust to this,” concluded the authors of the study, published in the British Journal of Dermatology.

There is a strong association between disease severity and colonization with S. aureus in patients with AD, and as many as 90% are colonized with the microbe but, the authors pointed out, it’s not entirely clear how S. aureus affects the development of AD.

They added that there’s been little research into the possible effects of changes in S. aureus clonal types over time. Still, “new studies indicate that specific clonal types could be linked to specific host phenotypes, illustrating that host-microbe interactions might be important for colonization of AD skin,” they said.

The authors, led by Maja-Lisa Clausen, MD, of the department of dermatology at the University of Copenhagen, tracked 63 adult patients with AD at Denmark’s Bispebjerg Hospital from 2013-2015 to a 2016-2017 follow-up period. Their mean age was 36 years.

They analyzed bacterial swabs taken from the nose, lesional skin, and nonlesional skin. Of the 63 participants, 47 (75%) were colonized with S. aureus in at least one location when the study began, and 27 of those (57%) were still colonized at follow-up. Of the 16 patients not colonized at baseline, 7 patients (44%) had become colonized by follow-up.

Of the 27 patients who were colonized at both time points, 14 (52%) had no change in CC type.

Those who were colonized at follow-up in at least one of the three sites sampled had more severe disease, with a mean SCORAD – or disease severity score – of 37, compared with those who were not colonized at that time, with a mean SCORAD of 28 (P = .067).

There was a much bigger gap in mean SCORAD score between the 14 patients who had the same CC type at both baseline and follow-up (a mean score of 30), compared with the 11 patients with different CC types at follow-up (a mean score of 47), a statistically significant difference (P = .03). Mean severity scores went up in those who changed CC types and down in those whose CC types remained the same.

The findings “illustrate that colonization changes over time, and also probably reflect the relapsing course of this disease, as colonization likely occurs in relation to worsening of the eczema,” the study authors wrote. They cautioned that “other factors should be taken into considerations as these are known to influence AD severity, including change in treatment regimens, climate, or other disease.”

Novo Nordisk Foundation funded the study. No relevant disclosures were reported.

SOURCE: Clausen, ML et al. Br J Dermatol. 2018 Aug 2. doi: 10.1111/bjd.17033.

A new study offers insight into the development of atopic dermatitis (AD) by linking the severity of the disease to colonization by different Staphylococcus aureus clonal complex (CC) types over time.

The research “suggests that different CC types might harbor different virulence factors and that the patient’s immune system needs to adjust to this,” concluded the authors of the study, published in the British Journal of Dermatology.

There is a strong association between disease severity and colonization with S. aureus in patients with AD, and as many as 90% are colonized with the microbe but, the authors pointed out, it’s not entirely clear how S. aureus affects the development of AD.

They added that there’s been little research into the possible effects of changes in S. aureus clonal types over time. Still, “new studies indicate that specific clonal types could be linked to specific host phenotypes, illustrating that host-microbe interactions might be important for colonization of AD skin,” they said.

The authors, led by Maja-Lisa Clausen, MD, of the department of dermatology at the University of Copenhagen, tracked 63 adult patients with AD at Denmark’s Bispebjerg Hospital from 2013-2015 to a 2016-2017 follow-up period. Their mean age was 36 years.

They analyzed bacterial swabs taken from the nose, lesional skin, and nonlesional skin. Of the 63 participants, 47 (75%) were colonized with S. aureus in at least one location when the study began, and 27 of those (57%) were still colonized at follow-up. Of the 16 patients not colonized at baseline, 7 patients (44%) had become colonized by follow-up.

Of the 27 patients who were colonized at both time points, 14 (52%) had no change in CC type.

Those who were colonized at follow-up in at least one of the three sites sampled had more severe disease, with a mean SCORAD – or disease severity score – of 37, compared with those who were not colonized at that time, with a mean SCORAD of 28 (P = .067).

There was a much bigger gap in mean SCORAD score between the 14 patients who had the same CC type at both baseline and follow-up (a mean score of 30), compared with the 11 patients with different CC types at follow-up (a mean score of 47), a statistically significant difference (P = .03). Mean severity scores went up in those who changed CC types and down in those whose CC types remained the same.

The findings “illustrate that colonization changes over time, and also probably reflect the relapsing course of this disease, as colonization likely occurs in relation to worsening of the eczema,” the study authors wrote. They cautioned that “other factors should be taken into considerations as these are known to influence AD severity, including change in treatment regimens, climate, or other disease.”

Novo Nordisk Foundation funded the study. No relevant disclosures were reported.

SOURCE: Clausen, ML et al. Br J Dermatol. 2018 Aug 2. doi: 10.1111/bjd.17033.

A new study offers insight into the development of atopic dermatitis (AD) by linking the severity of the disease to colonization by different Staphylococcus aureus clonal complex (CC) types over time.

The research “suggests that different CC types might harbor different virulence factors and that the patient’s immune system needs to adjust to this,” concluded the authors of the study, published in the British Journal of Dermatology.

There is a strong association between disease severity and colonization with S. aureus in patients with AD, and as many as 90% are colonized with the microbe but, the authors pointed out, it’s not entirely clear how S. aureus affects the development of AD.

They added that there’s been little research into the possible effects of changes in S. aureus clonal types over time. Still, “new studies indicate that specific clonal types could be linked to specific host phenotypes, illustrating that host-microbe interactions might be important for colonization of AD skin,” they said.

The authors, led by Maja-Lisa Clausen, MD, of the department of dermatology at the University of Copenhagen, tracked 63 adult patients with AD at Denmark’s Bispebjerg Hospital from 2013-2015 to a 2016-2017 follow-up period. Their mean age was 36 years.

They analyzed bacterial swabs taken from the nose, lesional skin, and nonlesional skin. Of the 63 participants, 47 (75%) were colonized with S. aureus in at least one location when the study began, and 27 of those (57%) were still colonized at follow-up. Of the 16 patients not colonized at baseline, 7 patients (44%) had become colonized by follow-up.

Of the 27 patients who were colonized at both time points, 14 (52%) had no change in CC type.

Those who were colonized at follow-up in at least one of the three sites sampled had more severe disease, with a mean SCORAD – or disease severity score – of 37, compared with those who were not colonized at that time, with a mean SCORAD of 28 (P = .067).

There was a much bigger gap in mean SCORAD score between the 14 patients who had the same CC type at both baseline and follow-up (a mean score of 30), compared with the 11 patients with different CC types at follow-up (a mean score of 47), a statistically significant difference (P = .03). Mean severity scores went up in those who changed CC types and down in those whose CC types remained the same.

The findings “illustrate that colonization changes over time, and also probably reflect the relapsing course of this disease, as colonization likely occurs in relation to worsening of the eczema,” the study authors wrote. They cautioned that “other factors should be taken into considerations as these are known to influence AD severity, including change in treatment regimens, climate, or other disease.”

Novo Nordisk Foundation funded the study. No relevant disclosures were reported.

SOURCE: Clausen, ML et al. Br J Dermatol. 2018 Aug 2. doi: 10.1111/bjd.17033.

Diabetic foot ulcers and infections can lead to osteomyelitis, a potentially devastating infection in the bone.

WILLSIE/Getty Images

How much of a difference can osteomyelitis make to a patient’s prognosis? A 2014 commentary by Benjamin A. Lipsky, MD, a prominent expert in problems associated with diabetic patients’ feet who’s with the University of Washington, Seattle, hints at the potential toll: “Overall, about 20% of patients with a diabetic foot infection (and over 60% of those with severe infections) have underlying osteomyelitis, which dramatically increases the risk of lower-extremity amputation” (Diabetes Care. 2014 Mar;37[3]:593-5).

Diagnosis of osteomyelitis, which relies on a bone biopsy, is clearly important. But there’s a big gap in diagnostic findings depending on whether doctors request culture or histology results, according to a new study released at the 2018 scientific meeting of the American Diabetes Association (Diabetes. 2018 Jul. doi: 10.2337/db18-110-OR).

In an interview, lead author and podiatrist Peter A. Crisologo, DPM, of University of Texas Southwestern Medical Center, Dallas, explained the study findings and offered guidance for requesting bone biopsies in possible cases of osteomyelitis.

Q: What makes diagnosis and treatment of osteomyelitis unique?

A: In the foot, there’s not a lot of soft tissue between the outside world and your bone. If the wounds on the feet go deep enough, they can spread a bacterial infection to the bone. This changes how foot infections are treated.
 

If you have a skin infection, it requires 11-12 days of antibiotics. Things start ramping up once you start getting into the bone. You’re talking potential surgery and 6 weeks of antibiotics through IV treatments. This is why it’s really important that you get your diagnosis right.

A lot of people say “I’m going to do the safe thing” and treat a bone infection with an extended course of antibiotics.

That’s not necessarily safe. If you’re overdiagnosing – for example, you identify bacteria that’s just a contaminant – you could put a patient through 6 weeks of IV treatment along with the risks of a PICC (peripherally inserted central catheter ) line infection, complications from IV placement, and complications from the antibiotic.

Also, acute kidney injury develops in at least a third of the patients who undergo 6 weeks of antibiotics. That’s not to mention the cost of the visits and the labs you have to draw. But we don’t want to underdiagnose either. If osteomyelitis is underdiagnosed and then not treated, the infection can smolder and continue to progress and worsen.

Q: Your study looks at the bone biopsy. How does it fit into care of osteomyelitis in the diabetic foot?

A: A bone biopsy is the standard for diagnosis under the guidelines of the Infectious Diseases Society of America/International Working Group on the Diabetic Foot (Clin Infect Dis. 2012;54[12]:e132-73 ).
 

But beyond that, nobody says anything. Everyone has an operational definition of how a bone biopsy is interpreted, and there’s a need for a consensus on how a bone biopsy can be used to diagnose osteomyelitis.

You’ll get different percentages of your patients diagnosed with osteomyelitis. For example, someone may say the biopsy is only positive if the histology is positive, while another says the histology doesn’t matter if the culture is positive.

Q: Your study looks at histology and culture analyses. What do these reveal?

A: A traditional culture helps you identify the bacteria, as well as guide your treatment when it’s tested against antibiotics.
 

A traditional histology allows the pathologist to look under a microscope for signs of osteomyelitis: Do they see the right inflammatory cells, white cells, lymphocytes, combinations of cells? Does this look like an acute or chronic osteomyelitis?

Q: Why might it be wise to combine culture and histology analyses?

A: If you have bacteria that’s difficult to culture via traditional methods, it may be a bacteria that doesn’t grow well or easily. If you combine culture with histology, pathologists can look and say, “Your culture was negative but we see these other signs, so we feel this is osteomyelitis.”



Q: Your study examined 35 consecutive patients aged at least 21 years who had moderate or severe infections bone infections in the foot linked with type 1 diabetes (n = 4) or type 2 diabetes (n = 31).

The samples were analyzed via culture, histology, and culture/histology examinations. You also performed genetic sequencing (quantitative polymerase chain reaction targeting 16S rRNA). How does this test fit in to bone biopsies in the clinic?

A: That’s a newer method and not a standard of care treatment for the diabetic foot. This analysis looks at DNA that’s present, bypassing the analysis of difficult-to-grow bacteria.



Q: What did you discover?

A: In this study, histology had the lowest incidence of positively detecting osteomyelitis. (45.7%). The level increases when a culture is taken (68.6% vs. histology; P = .02).
 

Then it goes up when DNA is used because it’s catching everything (82.9%, P = .001 vs. histology and P = .31 vs. culture).

[The study also found that adding histology to culture or to genetic sequencing did not change positive findings.]

Q: Does the study suggest one approach is better than the others?

A: This paper doesn’t provide enough evidence to use one method over another. The main purpose was to raise the concern that diagnosis can change dramatically depending on how the gold standard of bone biopsy is interpreted.



Q: What were the pros and cons of the genetic sequencing approach?

A: When we use this approach, our positive diagnostic rate significantly increases. But there are also downsides. We don’t know whether the bacteria we see is alive or dead. We just know it was there. So are the patients truly positive? That’s a question we can’t answer.
 

Genetic sequencing also doesn’t tell us about susceptibilities to antibiotics.

Q: What is the take-home message here for physicians who may order bone biopsies?

A: The thing to do is request both traditional culture and traditional histology.
 

As far as DNA sequencing, that not something I’d recommend as a standard of care.

Q: Can you comment on cost and insurance coverage for these approaches?

A: As far as I know, genetic sequencing is not covered as it is not standard of care in the diabetic foot and is used mainly for research at this time.
 

Pathology and culture are standard of care when evaluating for osteomyelitis and should be a covered service. However, a patient should call their insurance company first prior to having the procedure done to see whether it is covered.

Q: What’s next for research in this area?

A: From here, the next step is bigger numbers: Increase the study size and look at this again. Also, we may be able to identify susceptibilities by identifying resistance within the DNA.



Dr. Crisologo and two other study authors report no relevant disclosures. One study author reported various disclosures including research support, consulting, and service on speakers' bureaus.
 

Diabetic foot ulcers and infections can lead to osteomyelitis, a potentially devastating infection in the bone.

WILLSIE/Getty Images

How much of a difference can osteomyelitis make to a patient’s prognosis? A 2014 commentary by Benjamin A. Lipsky, MD, a prominent expert in problems associated with diabetic patients’ feet who’s with the University of Washington, Seattle, hints at the potential toll: “Overall, about 20% of patients with a diabetic foot infection (and over 60% of those with severe infections) have underlying osteomyelitis, which dramatically increases the risk of lower-extremity amputation” (Diabetes Care. 2014 Mar;37[3]:593-5).

Diagnosis of osteomyelitis, which relies on a bone biopsy, is clearly important. But there’s a big gap in diagnostic findings depending on whether doctors request culture or histology results, according to a new study released at the 2018 scientific meeting of the American Diabetes Association (Diabetes. 2018 Jul. doi: 10.2337/db18-110-OR).

In an interview, lead author and podiatrist Peter A. Crisologo, DPM, of University of Texas Southwestern Medical Center, Dallas, explained the study findings and offered guidance for requesting bone biopsies in possible cases of osteomyelitis.

Q: What makes diagnosis and treatment of osteomyelitis unique?

A: In the foot, there’s not a lot of soft tissue between the outside world and your bone. If the wounds on the feet go deep enough, they can spread a bacterial infection to the bone. This changes how foot infections are treated.
 

If you have a skin infection, it requires 11-12 days of antibiotics. Things start ramping up once you start getting into the bone. You’re talking potential surgery and 6 weeks of antibiotics through IV treatments. This is why it’s really important that you get your diagnosis right.

A lot of people say “I’m going to do the safe thing” and treat a bone infection with an extended course of antibiotics.

That’s not necessarily safe. If you’re overdiagnosing – for example, you identify bacteria that’s just a contaminant – you could put a patient through 6 weeks of IV treatment along with the risks of a PICC (peripherally inserted central catheter ) line infection, complications from IV placement, and complications from the antibiotic.

Also, acute kidney injury develops in at least a third of the patients who undergo 6 weeks of antibiotics. That’s not to mention the cost of the visits and the labs you have to draw. But we don’t want to underdiagnose either. If osteomyelitis is underdiagnosed and then not treated, the infection can smolder and continue to progress and worsen.

Q: Your study looks at the bone biopsy. How does it fit into care of osteomyelitis in the diabetic foot?

A: A bone biopsy is the standard for diagnosis under the guidelines of the Infectious Diseases Society of America/International Working Group on the Diabetic Foot (Clin Infect Dis. 2012;54[12]:e132-73 ).
 

But beyond that, nobody says anything. Everyone has an operational definition of how a bone biopsy is interpreted, and there’s a need for a consensus on how a bone biopsy can be used to diagnose osteomyelitis.

You’ll get different percentages of your patients diagnosed with osteomyelitis. For example, someone may say the biopsy is only positive if the histology is positive, while another says the histology doesn’t matter if the culture is positive.

Q: Your study looks at histology and culture analyses. What do these reveal?

A: A traditional culture helps you identify the bacteria, as well as guide your treatment when it’s tested against antibiotics.
 

A traditional histology allows the pathologist to look under a microscope for signs of osteomyelitis: Do they see the right inflammatory cells, white cells, lymphocytes, combinations of cells? Does this look like an acute or chronic osteomyelitis?

Q: Why might it be wise to combine culture and histology analyses?

A: If you have bacteria that’s difficult to culture via traditional methods, it may be a bacteria that doesn’t grow well or easily. If you combine culture with histology, pathologists can look and say, “Your culture was negative but we see these other signs, so we feel this is osteomyelitis.”



Q: Your study examined 35 consecutive patients aged at least 21 years who had moderate or severe infections bone infections in the foot linked with type 1 diabetes (n = 4) or type 2 diabetes (n = 31).

The samples were analyzed via culture, histology, and culture/histology examinations. You also performed genetic sequencing (quantitative polymerase chain reaction targeting 16S rRNA). How does this test fit in to bone biopsies in the clinic?

A: That’s a newer method and not a standard of care treatment for the diabetic foot. This analysis looks at DNA that’s present, bypassing the analysis of difficult-to-grow bacteria.



Q: What did you discover?

A: In this study, histology had the lowest incidence of positively detecting osteomyelitis. (45.7%). The level increases when a culture is taken (68.6% vs. histology; P = .02).
 

Then it goes up when DNA is used because it’s catching everything (82.9%, P = .001 vs. histology and P = .31 vs. culture).

[The study also found that adding histology to culture or to genetic sequencing did not change positive findings.]

Q: Does the study suggest one approach is better than the others?

A: This paper doesn’t provide enough evidence to use one method over another. The main purpose was to raise the concern that diagnosis can change dramatically depending on how the gold standard of bone biopsy is interpreted.



Q: What were the pros and cons of the genetic sequencing approach?

A: When we use this approach, our positive diagnostic rate significantly increases. But there are also downsides. We don’t know whether the bacteria we see is alive or dead. We just know it was there. So are the patients truly positive? That’s a question we can’t answer.
 

Genetic sequencing also doesn’t tell us about susceptibilities to antibiotics.

Q: What is the take-home message here for physicians who may order bone biopsies?

A: The thing to do is request both traditional culture and traditional histology.
 

As far as DNA sequencing, that not something I’d recommend as a standard of care.

Q: Can you comment on cost and insurance coverage for these approaches?

A: As far as I know, genetic sequencing is not covered as it is not standard of care in the diabetic foot and is used mainly for research at this time.
 

Pathology and culture are standard of care when evaluating for osteomyelitis and should be a covered service. However, a patient should call their insurance company first prior to having the procedure done to see whether it is covered.

Q: What’s next for research in this area?

A: From here, the next step is bigger numbers: Increase the study size and look at this again. Also, we may be able to identify susceptibilities by identifying resistance within the DNA.



Dr. Crisologo and two other study authors report no relevant disclosures. One study author reported various disclosures including research support, consulting, and service on speakers' bureaus.
 

Diabetic foot ulcers and infections can lead to osteomyelitis, a potentially devastating infection in the bone.

WILLSIE/Getty Images

How much of a difference can osteomyelitis make to a patient’s prognosis? A 2014 commentary by Benjamin A. Lipsky, MD, a prominent expert in problems associated with diabetic patients’ feet who’s with the University of Washington, Seattle, hints at the potential toll: “Overall, about 20% of patients with a diabetic foot infection (and over 60% of those with severe infections) have underlying osteomyelitis, which dramatically increases the risk of lower-extremity amputation” (Diabetes Care. 2014 Mar;37[3]:593-5).

Diagnosis of osteomyelitis, which relies on a bone biopsy, is clearly important. But there’s a big gap in diagnostic findings depending on whether doctors request culture or histology results, according to a new study released at the 2018 scientific meeting of the American Diabetes Association (Diabetes. 2018 Jul. doi: 10.2337/db18-110-OR).

In an interview, lead author and podiatrist Peter A. Crisologo, DPM, of University of Texas Southwestern Medical Center, Dallas, explained the study findings and offered guidance for requesting bone biopsies in possible cases of osteomyelitis.

Q: What makes diagnosis and treatment of osteomyelitis unique?

A: In the foot, there’s not a lot of soft tissue between the outside world and your bone. If the wounds on the feet go deep enough, they can spread a bacterial infection to the bone. This changes how foot infections are treated.
 

If you have a skin infection, it requires 11-12 days of antibiotics. Things start ramping up once you start getting into the bone. You’re talking potential surgery and 6 weeks of antibiotics through IV treatments. This is why it’s really important that you get your diagnosis right.

A lot of people say “I’m going to do the safe thing” and treat a bone infection with an extended course of antibiotics.

That’s not necessarily safe. If you’re overdiagnosing – for example, you identify bacteria that’s just a contaminant – you could put a patient through 6 weeks of IV treatment along with the risks of a PICC (peripherally inserted central catheter ) line infection, complications from IV placement, and complications from the antibiotic.

Also, acute kidney injury develops in at least a third of the patients who undergo 6 weeks of antibiotics. That’s not to mention the cost of the visits and the labs you have to draw. But we don’t want to underdiagnose either. If osteomyelitis is underdiagnosed and then not treated, the infection can smolder and continue to progress and worsen.

Q: Your study looks at the bone biopsy. How does it fit into care of osteomyelitis in the diabetic foot?

A: A bone biopsy is the standard for diagnosis under the guidelines of the Infectious Diseases Society of America/International Working Group on the Diabetic Foot (Clin Infect Dis. 2012;54[12]:e132-73 ).
 

But beyond that, nobody says anything. Everyone has an operational definition of how a bone biopsy is interpreted, and there’s a need for a consensus on how a bone biopsy can be used to diagnose osteomyelitis.

You’ll get different percentages of your patients diagnosed with osteomyelitis. For example, someone may say the biopsy is only positive if the histology is positive, while another says the histology doesn’t matter if the culture is positive.

Q: Your study looks at histology and culture analyses. What do these reveal?

A: A traditional culture helps you identify the bacteria, as well as guide your treatment when it’s tested against antibiotics.
 

A traditional histology allows the pathologist to look under a microscope for signs of osteomyelitis: Do they see the right inflammatory cells, white cells, lymphocytes, combinations of cells? Does this look like an acute or chronic osteomyelitis?

Q: Why might it be wise to combine culture and histology analyses?

A: If you have bacteria that’s difficult to culture via traditional methods, it may be a bacteria that doesn’t grow well or easily. If you combine culture with histology, pathologists can look and say, “Your culture was negative but we see these other signs, so we feel this is osteomyelitis.”



Q: Your study examined 35 consecutive patients aged at least 21 years who had moderate or severe infections bone infections in the foot linked with type 1 diabetes (n = 4) or type 2 diabetes (n = 31).

The samples were analyzed via culture, histology, and culture/histology examinations. You also performed genetic sequencing (quantitative polymerase chain reaction targeting 16S rRNA). How does this test fit in to bone biopsies in the clinic?

A: That’s a newer method and not a standard of care treatment for the diabetic foot. This analysis looks at DNA that’s present, bypassing the analysis of difficult-to-grow bacteria.



Q: What did you discover?

A: In this study, histology had the lowest incidence of positively detecting osteomyelitis. (45.7%). The level increases when a culture is taken (68.6% vs. histology; P = .02).
 

Then it goes up when DNA is used because it’s catching everything (82.9%, P = .001 vs. histology and P = .31 vs. culture).

[The study also found that adding histology to culture or to genetic sequencing did not change positive findings.]

Q: Does the study suggest one approach is better than the others?

A: This paper doesn’t provide enough evidence to use one method over another. The main purpose was to raise the concern that diagnosis can change dramatically depending on how the gold standard of bone biopsy is interpreted.



Q: What were the pros and cons of the genetic sequencing approach?

A: When we use this approach, our positive diagnostic rate significantly increases. But there are also downsides. We don’t know whether the bacteria we see is alive or dead. We just know it was there. So are the patients truly positive? That’s a question we can’t answer.
 

Genetic sequencing also doesn’t tell us about susceptibilities to antibiotics.

Q: What is the take-home message here for physicians who may order bone biopsies?

A: The thing to do is request both traditional culture and traditional histology.
 

As far as DNA sequencing, that not something I’d recommend as a standard of care.

Q: Can you comment on cost and insurance coverage for these approaches?

A: As far as I know, genetic sequencing is not covered as it is not standard of care in the diabetic foot and is used mainly for research at this time.
 

Pathology and culture are standard of care when evaluating for osteomyelitis and should be a covered service. However, a patient should call their insurance company first prior to having the procedure done to see whether it is covered.

Q: What’s next for research in this area?

A: From here, the next step is bigger numbers: Increase the study size and look at this again. Also, we may be able to identify susceptibilities by identifying resistance within the DNA.



Dr. Crisologo and two other study authors report no relevant disclosures. One study author reported various disclosures including research support, consulting, and service on speakers' bureaus.
 

Two reports in the BMJ regarding new research offer grim tidings about mortality in the United States: One study has suggested the opioid epidemic is driving down life expectancy, and another has found that midlife death rates from multiple causes are on the rise across ethnic groups.

“Death rates are increasing across the U.S. population for dozens of conditions,” according to Steven H. Woolf, MD, MPH, a professor at Virginia Commonwealth University, Richmond, and his associates, who together wrote the second study. “Of particular urgency is recognizing that the unfavorable mortality pattern that began for some groups in the 1990s is now unfolding among Hispanics and non-Hispanic blacks, a development made more consequential by their high baseline mortality rates.”

Dr. Woolf and his coinvestigators tracked midlife mortality (ages 25-64 years) from 1999-2016 across the U.S. population.

They found that all-cause mortality jumped among whites, American Indians, and Alaska Natives over that time. A trend toward decreasing all-cause mortality ended in 2009-2011 among African Americans, Hispanic American, Asian Americans, and Americans of Pacific Islander descent.

“Drug overdoses were the leading cause of increased mortality in midlife in each population, but mortality also increased for alcohol related conditions, suicides, and organ diseases involving multiple body systems,” according to the researchers.

For the life expectancy study, which was published in the BMJ, researchers led by Jessica Y. Ho, PhD, of the University of Southern California, Los Angeles, tracked all-cause and cause-specific mortality in 18 high-income nations. They focused on the years 2014-2016.

Most of the nations saw declines in life expectancy from 2014-2015, mainly caused by older people dying from physical diseases and mental disorders. From 2015-2016, most of these nations saw their life expectancy levels rebound and experienced “robust gains.”

In the United States, however, life expectancy at birth for women fell from 81.47 years in 2014 to 81.35 years in 2015, and rose to 81.40 years in 2016.

For men, life expectancy fell continuously from 76.67 years in 2014 to 76.50 years in 2015 to 76.40 years in 2016.

In 2016, these life expectancies were the lowest of 17 nations examined in the study. (Statistics from the 18th nation in the study, Canada, were not included for 2016).

The United States was an outlier in other ways. For one, deaths among people younger than 65 years were the major contributor to the life expectancy decline.

And causes of death were also different than other countries: “For American women, drug overdose and external causes, and respiratory and cardiovascular diseases, contributed roughly equally to the decline in life expectancy, but for American men, nearly all of the decline was attributable to drug overdose and external causes.”

No funding is reported for the death rates study. The study authors report no relevant disclosures.

The life expectancy study was supported by the Robert Wood Johnson Foundation. Authors variously report support from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institute on Aging, and the National Institute of Child Health and Human Development.

SOURCE: Ho JY et al. BMJ. 2018;362:k2562; Woolf SH et al. BMJ 2018;362:k3096.

Two reports in the BMJ regarding new research offer grim tidings about mortality in the United States: One study has suggested the opioid epidemic is driving down life expectancy, and another has found that midlife death rates from multiple causes are on the rise across ethnic groups.

“Death rates are increasing across the U.S. population for dozens of conditions,” according to Steven H. Woolf, MD, MPH, a professor at Virginia Commonwealth University, Richmond, and his associates, who together wrote the second study. “Of particular urgency is recognizing that the unfavorable mortality pattern that began for some groups in the 1990s is now unfolding among Hispanics and non-Hispanic blacks, a development made more consequential by their high baseline mortality rates.”

Dr. Woolf and his coinvestigators tracked midlife mortality (ages 25-64 years) from 1999-2016 across the U.S. population.

They found that all-cause mortality jumped among whites, American Indians, and Alaska Natives over that time. A trend toward decreasing all-cause mortality ended in 2009-2011 among African Americans, Hispanic American, Asian Americans, and Americans of Pacific Islander descent.

“Drug overdoses were the leading cause of increased mortality in midlife in each population, but mortality also increased for alcohol related conditions, suicides, and organ diseases involving multiple body systems,” according to the researchers.

For the life expectancy study, which was published in the BMJ, researchers led by Jessica Y. Ho, PhD, of the University of Southern California, Los Angeles, tracked all-cause and cause-specific mortality in 18 high-income nations. They focused on the years 2014-2016.

Most of the nations saw declines in life expectancy from 2014-2015, mainly caused by older people dying from physical diseases and mental disorders. From 2015-2016, most of these nations saw their life expectancy levels rebound and experienced “robust gains.”

In the United States, however, life expectancy at birth for women fell from 81.47 years in 2014 to 81.35 years in 2015, and rose to 81.40 years in 2016.

For men, life expectancy fell continuously from 76.67 years in 2014 to 76.50 years in 2015 to 76.40 years in 2016.

In 2016, these life expectancies were the lowest of 17 nations examined in the study. (Statistics from the 18th nation in the study, Canada, were not included for 2016).

The United States was an outlier in other ways. For one, deaths among people younger than 65 years were the major contributor to the life expectancy decline.

And causes of death were also different than other countries: “For American women, drug overdose and external causes, and respiratory and cardiovascular diseases, contributed roughly equally to the decline in life expectancy, but for American men, nearly all of the decline was attributable to drug overdose and external causes.”

No funding is reported for the death rates study. The study authors report no relevant disclosures.

The life expectancy study was supported by the Robert Wood Johnson Foundation. Authors variously report support from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institute on Aging, and the National Institute of Child Health and Human Development.

SOURCE: Ho JY et al. BMJ. 2018;362:k2562; Woolf SH et al. BMJ 2018;362:k3096.

Two reports in the BMJ regarding new research offer grim tidings about mortality in the United States: One study has suggested the opioid epidemic is driving down life expectancy, and another has found that midlife death rates from multiple causes are on the rise across ethnic groups.

“Death rates are increasing across the U.S. population for dozens of conditions,” according to Steven H. Woolf, MD, MPH, a professor at Virginia Commonwealth University, Richmond, and his associates, who together wrote the second study. “Of particular urgency is recognizing that the unfavorable mortality pattern that began for some groups in the 1990s is now unfolding among Hispanics and non-Hispanic blacks, a development made more consequential by their high baseline mortality rates.”

Dr. Woolf and his coinvestigators tracked midlife mortality (ages 25-64 years) from 1999-2016 across the U.S. population.

They found that all-cause mortality jumped among whites, American Indians, and Alaska Natives over that time. A trend toward decreasing all-cause mortality ended in 2009-2011 among African Americans, Hispanic American, Asian Americans, and Americans of Pacific Islander descent.

“Drug overdoses were the leading cause of increased mortality in midlife in each population, but mortality also increased for alcohol related conditions, suicides, and organ diseases involving multiple body systems,” according to the researchers.

For the life expectancy study, which was published in the BMJ, researchers led by Jessica Y. Ho, PhD, of the University of Southern California, Los Angeles, tracked all-cause and cause-specific mortality in 18 high-income nations. They focused on the years 2014-2016.

Most of the nations saw declines in life expectancy from 2014-2015, mainly caused by older people dying from physical diseases and mental disorders. From 2015-2016, most of these nations saw their life expectancy levels rebound and experienced “robust gains.”

In the United States, however, life expectancy at birth for women fell from 81.47 years in 2014 to 81.35 years in 2015, and rose to 81.40 years in 2016.

For men, life expectancy fell continuously from 76.67 years in 2014 to 76.50 years in 2015 to 76.40 years in 2016.

In 2016, these life expectancies were the lowest of 17 nations examined in the study. (Statistics from the 18th nation in the study, Canada, were not included for 2016).

The United States was an outlier in other ways. For one, deaths among people younger than 65 years were the major contributor to the life expectancy decline.

And causes of death were also different than other countries: “For American women, drug overdose and external causes, and respiratory and cardiovascular diseases, contributed roughly equally to the decline in life expectancy, but for American men, nearly all of the decline was attributable to drug overdose and external causes.”

No funding is reported for the death rates study. The study authors report no relevant disclosures.

The life expectancy study was supported by the Robert Wood Johnson Foundation. Authors variously report support from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institute on Aging, and the National Institute of Child Health and Human Development.

SOURCE: Ho JY et al. BMJ. 2018;362:k2562; Woolf SH et al. BMJ 2018;362:k3096.

Pregnant lesbian and bisexual women who seek abortions are more likely than are their heterosexual counterparts to be the victims of violence by the men who impregnated them, a new study finds.

Rachel K. Jones, PhD, of the Guttmacher Institute, New York, and her associates also found that these sexual minority women, plus a group of individuals who described their sexual orientation as “something else,” were much more likely to report exposure to sexual and physical violence.

“No patient should be presumed to be heterosexual for any reason, including a pregnancy history. All pregnancies – like all patients – should be treated as unique and operating within the dynamic and interconnected circumstances of peoples’ lives, which may encompass differences in sexual orientation and exposure to violence,” the researchers wrote. Their report is in Obstetrics & Gynecology.

Previous research has suggested that nonheterosexual women are more likely than are straight women to become pregnant unintentionally. There also are signs suggesting that they have more abortions, too, although the findings are iffy, the study authors wrote.

For this study, Dr. Jones and her associates examined questionnaire answers of 8,380 women who responded to the Guttmacher Institute’s 2014 Abortion Patient Survey. All were undergoing abortions at 87 U.S. nonhospital facilities that performed 30 or more abortions each per year.

Of the sample, about 9% declined to describe their sexual orientation. Of the rest, 94% described themselves as heterosexual; of those, 41% were white, 28% were black, and 22% were Hispanic. Most were in their 20s, 47% were never married, and 48% had incomes below the federal poverty level.

Women also described themselves as bisexual (4%), “something else” (1%), and lesbian (0.4%). All these groups were more likely than were heterosexuals to be below the federal poverty level; more than half of the lesbian and bisexual respondents said they had previously given birth.

Fifteen percent of lesbians said their current pregnancy was caused by forced sex, compared with 1% of heterosexuals and 3% of bisexuals. (P less than .001).

Bisexuals (9%) and lesbians (33%) were more likely than were heterosexuals (4%) to say the men who impregnated them had physically abused them. The same was true for sexual abuse, which was reported by 7% of bisexuals, 35% of lesbians, and 2% of heterosexuals. After the researchers controlled for various factors including age and race, lesbians remained much more likely to report physical abuse, sexual abuse, and forced sex at the hands of the men who impregnated them (odds ratios = 15, 25, and 10, respectively, P less than .001).

“Exposure to physical and sexual violence was substantially higher among each of the sexual minority groups compared with their heterosexual counterparts, sometimes by a factor of 15 or more,” the study authors wrote. “We found that lesbian respondents had the highest levels of exposure to violence, perhaps because this population was more likely to have had sex with a man only in the context of forced sex.”

The researchers noted that their study has various limitations, such as low numbers of sexual minority women and the 4-year gap since the data were collected.

SOURCE: Jones R et al. Obstet Gynecol. 2018 Sep;132(3):605-11.

Pregnant lesbian and bisexual women who seek abortions are more likely than are their heterosexual counterparts to be the victims of violence by the men who impregnated them, a new study finds.

Rachel K. Jones, PhD, of the Guttmacher Institute, New York, and her associates also found that these sexual minority women, plus a group of individuals who described their sexual orientation as “something else,” were much more likely to report exposure to sexual and physical violence.

“No patient should be presumed to be heterosexual for any reason, including a pregnancy history. All pregnancies – like all patients – should be treated as unique and operating within the dynamic and interconnected circumstances of peoples’ lives, which may encompass differences in sexual orientation and exposure to violence,” the researchers wrote. Their report is in Obstetrics & Gynecology.

Previous research has suggested that nonheterosexual women are more likely than are straight women to become pregnant unintentionally. There also are signs suggesting that they have more abortions, too, although the findings are iffy, the study authors wrote.

For this study, Dr. Jones and her associates examined questionnaire answers of 8,380 women who responded to the Guttmacher Institute’s 2014 Abortion Patient Survey. All were undergoing abortions at 87 U.S. nonhospital facilities that performed 30 or more abortions each per year.

Of the sample, about 9% declined to describe their sexual orientation. Of the rest, 94% described themselves as heterosexual; of those, 41% were white, 28% were black, and 22% were Hispanic. Most were in their 20s, 47% were never married, and 48% had incomes below the federal poverty level.

Women also described themselves as bisexual (4%), “something else” (1%), and lesbian (0.4%). All these groups were more likely than were heterosexuals to be below the federal poverty level; more than half of the lesbian and bisexual respondents said they had previously given birth.

Fifteen percent of lesbians said their current pregnancy was caused by forced sex, compared with 1% of heterosexuals and 3% of bisexuals. (P less than .001).

Bisexuals (9%) and lesbians (33%) were more likely than were heterosexuals (4%) to say the men who impregnated them had physically abused them. The same was true for sexual abuse, which was reported by 7% of bisexuals, 35% of lesbians, and 2% of heterosexuals. After the researchers controlled for various factors including age and race, lesbians remained much more likely to report physical abuse, sexual abuse, and forced sex at the hands of the men who impregnated them (odds ratios = 15, 25, and 10, respectively, P less than .001).

“Exposure to physical and sexual violence was substantially higher among each of the sexual minority groups compared with their heterosexual counterparts, sometimes by a factor of 15 or more,” the study authors wrote. “We found that lesbian respondents had the highest levels of exposure to violence, perhaps because this population was more likely to have had sex with a man only in the context of forced sex.”

The researchers noted that their study has various limitations, such as low numbers of sexual minority women and the 4-year gap since the data were collected.

SOURCE: Jones R et al. Obstet Gynecol. 2018 Sep;132(3):605-11.

Pregnant lesbian and bisexual women who seek abortions are more likely than are their heterosexual counterparts to be the victims of violence by the men who impregnated them, a new study finds.

Rachel K. Jones, PhD, of the Guttmacher Institute, New York, and her associates also found that these sexual minority women, plus a group of individuals who described their sexual orientation as “something else,” were much more likely to report exposure to sexual and physical violence.

“No patient should be presumed to be heterosexual for any reason, including a pregnancy history. All pregnancies – like all patients – should be treated as unique and operating within the dynamic and interconnected circumstances of peoples’ lives, which may encompass differences in sexual orientation and exposure to violence,” the researchers wrote. Their report is in Obstetrics & Gynecology.

Previous research has suggested that nonheterosexual women are more likely than are straight women to become pregnant unintentionally. There also are signs suggesting that they have more abortions, too, although the findings are iffy, the study authors wrote.

For this study, Dr. Jones and her associates examined questionnaire answers of 8,380 women who responded to the Guttmacher Institute’s 2014 Abortion Patient Survey. All were undergoing abortions at 87 U.S. nonhospital facilities that performed 30 or more abortions each per year.

Of the sample, about 9% declined to describe their sexual orientation. Of the rest, 94% described themselves as heterosexual; of those, 41% were white, 28% were black, and 22% were Hispanic. Most were in their 20s, 47% were never married, and 48% had incomes below the federal poverty level.

Women also described themselves as bisexual (4%), “something else” (1%), and lesbian (0.4%). All these groups were more likely than were heterosexuals to be below the federal poverty level; more than half of the lesbian and bisexual respondents said they had previously given birth.

Fifteen percent of lesbians said their current pregnancy was caused by forced sex, compared with 1% of heterosexuals and 3% of bisexuals. (P less than .001).

Bisexuals (9%) and lesbians (33%) were more likely than were heterosexuals (4%) to say the men who impregnated them had physically abused them. The same was true for sexual abuse, which was reported by 7% of bisexuals, 35% of lesbians, and 2% of heterosexuals. After the researchers controlled for various factors including age and race, lesbians remained much more likely to report physical abuse, sexual abuse, and forced sex at the hands of the men who impregnated them (odds ratios = 15, 25, and 10, respectively, P less than .001).

“Exposure to physical and sexual violence was substantially higher among each of the sexual minority groups compared with their heterosexual counterparts, sometimes by a factor of 15 or more,” the study authors wrote. “We found that lesbian respondents had the highest levels of exposure to violence, perhaps because this population was more likely to have had sex with a man only in the context of forced sex.”

The researchers noted that their study has various limitations, such as low numbers of sexual minority women and the 4-year gap since the data were collected.

SOURCE: Jones R et al. Obstet Gynecol. 2018 Sep;132(3):605-11.

A new study of Medicaid-covered women who sought long-acting reversible contraception via subdermal etonogestrel implants or IUDs found that levels of continuation at 1 year were high, and complication rates were low.

flocu/ThinkStock

There was little difference between the groups on both fronts.

“This study demonstrates high rates of continued use of subdermal and intrauterine contraceptives by Medicaid clients, particularly among adolescents, and therefore, interventions that increase adolescent access to these contraceptives are likely to be cost effective from the payer perspective,” the study authors wrote in Contraception.

The study, led by Max J. Romano, MD, MPH, of MedStar Franklin Square Medical Center in Baltimore, retrospectively examined the medical claims of 3,305 women treated via MedStar Family Choice, a Medicaid managed-choice insurer.

The women, who lived in Maryland and the District of Columbia, were aged 15-44 years when they underwent contraceptive treatment during 2012-2015. Of the women, 1,335 had subdermal etonogestrel implants inserted, and 1,970 had IUDs inserted. Researchers followed the women for a mean 344 days.

The implant users were younger than the IUD group (mean age, 25 years vs. 28 years; P = less than .001), and women under age 20 years were more than more than twice as likely to get implants than IUDs (71% vs. 29%).

Women older than 20 years were more likely to get IUDs than implants, with those older than 25 preferring them by a ratio of 70% to 30%.

After researchers controlled for such factors as age group and year of insertion, they found that implant recipients were slightly more likely to still have the contraception tool in place at 1 year: 81% (implants) vs. IUDs (77%; P = .01). It’s not clear why women had their implants or IUDs removed.

Claims for complications were similar between the groups (8% for implants, 7% for IUDs), and researchers didn’t find a statistically significant difference after they controlled for various factors. Dysfunctional uterine bleeding was the most common complication, followed by excessive or frequent menstruation.

Few women reported pregnancy among the implant (0.82%) and IUD (0.86%) groups, and there was no statistically significant difference between the groups.

The researchers reported that their study has various limitations: The insurance claims information may provide misleading information about minor complications, and it doesn’t include details about abortions. The claims also may not report IUD expulsions and self-removals.

The authors also noted that they didn’t control for factors like socioeconomic status, psychological conditions, and multimorbidity.

MedStar Family Choice provided study funding. Dr. Romano and Loral Patchen, PhD, disclosed receiving free CME trainings and insertion certification regarding the long-acting contraceptive devices discussed in the study from Merck, Bayer, and Teva. Dr. Patchen disclosed serving on the Diclegis speakers bureau.

SOURCE: Romano MJ et al. Contraception. 2018 Aug;98:125-9.

A new study of Medicaid-covered women who sought long-acting reversible contraception via subdermal etonogestrel implants or IUDs found that levels of continuation at 1 year were high, and complication rates were low.

flocu/ThinkStock

There was little difference between the groups on both fronts.

“This study demonstrates high rates of continued use of subdermal and intrauterine contraceptives by Medicaid clients, particularly among adolescents, and therefore, interventions that increase adolescent access to these contraceptives are likely to be cost effective from the payer perspective,” the study authors wrote in Contraception.

The study, led by Max J. Romano, MD, MPH, of MedStar Franklin Square Medical Center in Baltimore, retrospectively examined the medical claims of 3,305 women treated via MedStar Family Choice, a Medicaid managed-choice insurer.

The women, who lived in Maryland and the District of Columbia, were aged 15-44 years when they underwent contraceptive treatment during 2012-2015. Of the women, 1,335 had subdermal etonogestrel implants inserted, and 1,970 had IUDs inserted. Researchers followed the women for a mean 344 days.

The implant users were younger than the IUD group (mean age, 25 years vs. 28 years; P = less than .001), and women under age 20 years were more than more than twice as likely to get implants than IUDs (71% vs. 29%).

Women older than 20 years were more likely to get IUDs than implants, with those older than 25 preferring them by a ratio of 70% to 30%.

After researchers controlled for such factors as age group and year of insertion, they found that implant recipients were slightly more likely to still have the contraception tool in place at 1 year: 81% (implants) vs. IUDs (77%; P = .01). It’s not clear why women had their implants or IUDs removed.

Claims for complications were similar between the groups (8% for implants, 7% for IUDs), and researchers didn’t find a statistically significant difference after they controlled for various factors. Dysfunctional uterine bleeding was the most common complication, followed by excessive or frequent menstruation.

Few women reported pregnancy among the implant (0.82%) and IUD (0.86%) groups, and there was no statistically significant difference between the groups.

The researchers reported that their study has various limitations: The insurance claims information may provide misleading information about minor complications, and it doesn’t include details about abortions. The claims also may not report IUD expulsions and self-removals.

The authors also noted that they didn’t control for factors like socioeconomic status, psychological conditions, and multimorbidity.

MedStar Family Choice provided study funding. Dr. Romano and Loral Patchen, PhD, disclosed receiving free CME trainings and insertion certification regarding the long-acting contraceptive devices discussed in the study from Merck, Bayer, and Teva. Dr. Patchen disclosed serving on the Diclegis speakers bureau.

SOURCE: Romano MJ et al. Contraception. 2018 Aug;98:125-9.

A new study of Medicaid-covered women who sought long-acting reversible contraception via subdermal etonogestrel implants or IUDs found that levels of continuation at 1 year were high, and complication rates were low.

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There was little difference between the groups on both fronts.

“This study demonstrates high rates of continued use of subdermal and intrauterine contraceptives by Medicaid clients, particularly among adolescents, and therefore, interventions that increase adolescent access to these contraceptives are likely to be cost effective from the payer perspective,” the study authors wrote in Contraception.

The study, led by Max J. Romano, MD, MPH, of MedStar Franklin Square Medical Center in Baltimore, retrospectively examined the medical claims of 3,305 women treated via MedStar Family Choice, a Medicaid managed-choice insurer.

The women, who lived in Maryland and the District of Columbia, were aged 15-44 years when they underwent contraceptive treatment during 2012-2015. Of the women, 1,335 had subdermal etonogestrel implants inserted, and 1,970 had IUDs inserted. Researchers followed the women for a mean 344 days.

The implant users were younger than the IUD group (mean age, 25 years vs. 28 years; P = less than .001), and women under age 20 years were more than more than twice as likely to get implants than IUDs (71% vs. 29%).

Women older than 20 years were more likely to get IUDs than implants, with those older than 25 preferring them by a ratio of 70% to 30%.

After researchers controlled for such factors as age group and year of insertion, they found that implant recipients were slightly more likely to still have the contraception tool in place at 1 year: 81% (implants) vs. IUDs (77%; P = .01). It’s not clear why women had their implants or IUDs removed.

Claims for complications were similar between the groups (8% for implants, 7% for IUDs), and researchers didn’t find a statistically significant difference after they controlled for various factors. Dysfunctional uterine bleeding was the most common complication, followed by excessive or frequent menstruation.

Few women reported pregnancy among the implant (0.82%) and IUD (0.86%) groups, and there was no statistically significant difference between the groups.

The researchers reported that their study has various limitations: The insurance claims information may provide misleading information about minor complications, and it doesn’t include details about abortions. The claims also may not report IUD expulsions and self-removals.

The authors also noted that they didn’t control for factors like socioeconomic status, psychological conditions, and multimorbidity.

MedStar Family Choice provided study funding. Dr. Romano and Loral Patchen, PhD, disclosed receiving free CME trainings and insertion certification regarding the long-acting contraceptive devices discussed in the study from Merck, Bayer, and Teva. Dr. Patchen disclosed serving on the Diclegis speakers bureau.

SOURCE: Romano MJ et al. Contraception. 2018 Aug;98:125-9.

A newly developed IUD that’s inserted shortly after cesarean section is less likely to be expelled within 3 months than another type of IUD that’s inserted the same way, according to results of a Turkish study.

The study authors, led by Ceren Unal, MD, of Zeynep Kamil Women’s and Children’s Disease Training and Research Hospital, Istanbul, wrote that the new device, the frameless copper-releasing Gyn-CS IUD, “could be a major advance, potentially suitable for general use due to the ease and safety of the insertion procedure,” which requires limited training.

According to the study authors, most IUDs are retained in the uterus, and most have a T-shape configuration. Some are inserted immediately following expulsion of the placenta at birth, although techniques “are far from being optimal,” and devices are frequently displaced and sometimes expelled.

The newly developed Gyn-CS IUD, a redesigned version of a previous model, has an alternative “anchor” design.

The investigators tracked 140 pregnant women – 106 who underwent elective cesarean section and 34 who underwent emergency cesarean section – who had the Gyn-CS or the TCu380A IUD inserted shortly after they gave birth. Their median age was around 30 years , all were white, and all were married.

The TCu380A IUD, a decades-old model that’s been recommended by the World Health Organization, and the Gyn-CS IUD were each inserted in 70 women. The researchers then followed them for 3 months. Three women (one in the Gyn-CS IUD group and two in the TCu380A IUD group) were lost to follow-up.

In total, 61 of 70 IUDs (88%) remained in place in the Gyn-CS group, and 54 of 70 (79%) in the TCu380A group (P = .30). One (1%) Gyn-CS IUD was expelled , possibly because it was incorrectly anchored, and eight (11%) TCu380A IUDs were expelled (P = .04). There were equal numbers of medical removals (four) and nonmedical removals (two) in the two groups, and one “other medical removal” in the Gyn-CS IUD group.

“The very low expulsion rate of Gyn-CS, compared with TCu380A, is a very strong argument in favor of the anchored IUD, preventing expulsion and displacement,” Dr. Unal and colleagues reported in Contraception.

They noted that the study has a limited 3-month tracking period, but they also pointed out that most expulsions inserted post partum occurred in the initial 6 weeks.

The low expulsion rate of the Gyn-CS device “will prevent more women becoming pregnant too soon which constitutes an important safety issue during future pregnancy,” the authors wrote. “The device, preferably its high-load 10-year version, could also interest many women as a reversible alternative for tubal sterilization. Additional clinical experience with the Gyn-CS IUD is, therefore, urgently warranted.”

No study funding is reported, although Contrel Research provided the Gyn-CS devices at no charge. The study authors reported no relevant disclosures.

SOURCE: Unal C et al. Contraception. 2018 Aug;98:135-40.

A newly developed IUD that’s inserted shortly after cesarean section is less likely to be expelled within 3 months than another type of IUD that’s inserted the same way, according to results of a Turkish study.

The study authors, led by Ceren Unal, MD, of Zeynep Kamil Women’s and Children’s Disease Training and Research Hospital, Istanbul, wrote that the new device, the frameless copper-releasing Gyn-CS IUD, “could be a major advance, potentially suitable for general use due to the ease and safety of the insertion procedure,” which requires limited training.

According to the study authors, most IUDs are retained in the uterus, and most have a T-shape configuration. Some are inserted immediately following expulsion of the placenta at birth, although techniques “are far from being optimal,” and devices are frequently displaced and sometimes expelled.

The newly developed Gyn-CS IUD, a redesigned version of a previous model, has an alternative “anchor” design.

The investigators tracked 140 pregnant women – 106 who underwent elective cesarean section and 34 who underwent emergency cesarean section – who had the Gyn-CS or the TCu380A IUD inserted shortly after they gave birth. Their median age was around 30 years , all were white, and all were married.

The TCu380A IUD, a decades-old model that’s been recommended by the World Health Organization, and the Gyn-CS IUD were each inserted in 70 women. The researchers then followed them for 3 months. Three women (one in the Gyn-CS IUD group and two in the TCu380A IUD group) were lost to follow-up.

In total, 61 of 70 IUDs (88%) remained in place in the Gyn-CS group, and 54 of 70 (79%) in the TCu380A group (P = .30). One (1%) Gyn-CS IUD was expelled , possibly because it was incorrectly anchored, and eight (11%) TCu380A IUDs were expelled (P = .04). There were equal numbers of medical removals (four) and nonmedical removals (two) in the two groups, and one “other medical removal” in the Gyn-CS IUD group.

“The very low expulsion rate of Gyn-CS, compared with TCu380A, is a very strong argument in favor of the anchored IUD, preventing expulsion and displacement,” Dr. Unal and colleagues reported in Contraception.

They noted that the study has a limited 3-month tracking period, but they also pointed out that most expulsions inserted post partum occurred in the initial 6 weeks.

The low expulsion rate of the Gyn-CS device “will prevent more women becoming pregnant too soon which constitutes an important safety issue during future pregnancy,” the authors wrote. “The device, preferably its high-load 10-year version, could also interest many women as a reversible alternative for tubal sterilization. Additional clinical experience with the Gyn-CS IUD is, therefore, urgently warranted.”

No study funding is reported, although Contrel Research provided the Gyn-CS devices at no charge. The study authors reported no relevant disclosures.

SOURCE: Unal C et al. Contraception. 2018 Aug;98:135-40.

A newly developed IUD that’s inserted shortly after cesarean section is less likely to be expelled within 3 months than another type of IUD that’s inserted the same way, according to results of a Turkish study.

The study authors, led by Ceren Unal, MD, of Zeynep Kamil Women’s and Children’s Disease Training and Research Hospital, Istanbul, wrote that the new device, the frameless copper-releasing Gyn-CS IUD, “could be a major advance, potentially suitable for general use due to the ease and safety of the insertion procedure,” which requires limited training.

According to the study authors, most IUDs are retained in the uterus, and most have a T-shape configuration. Some are inserted immediately following expulsion of the placenta at birth, although techniques “are far from being optimal,” and devices are frequently displaced and sometimes expelled.

The newly developed Gyn-CS IUD, a redesigned version of a previous model, has an alternative “anchor” design.

The investigators tracked 140 pregnant women – 106 who underwent elective cesarean section and 34 who underwent emergency cesarean section – who had the Gyn-CS or the TCu380A IUD inserted shortly after they gave birth. Their median age was around 30 years , all were white, and all were married.

The TCu380A IUD, a decades-old model that’s been recommended by the World Health Organization, and the Gyn-CS IUD were each inserted in 70 women. The researchers then followed them for 3 months. Three women (one in the Gyn-CS IUD group and two in the TCu380A IUD group) were lost to follow-up.

In total, 61 of 70 IUDs (88%) remained in place in the Gyn-CS group, and 54 of 70 (79%) in the TCu380A group (P = .30). One (1%) Gyn-CS IUD was expelled , possibly because it was incorrectly anchored, and eight (11%) TCu380A IUDs were expelled (P = .04). There were equal numbers of medical removals (four) and nonmedical removals (two) in the two groups, and one “other medical removal” in the Gyn-CS IUD group.

“The very low expulsion rate of Gyn-CS, compared with TCu380A, is a very strong argument in favor of the anchored IUD, preventing expulsion and displacement,” Dr. Unal and colleagues reported in Contraception.

They noted that the study has a limited 3-month tracking period, but they also pointed out that most expulsions inserted post partum occurred in the initial 6 weeks.

The low expulsion rate of the Gyn-CS device “will prevent more women becoming pregnant too soon which constitutes an important safety issue during future pregnancy,” the authors wrote. “The device, preferably its high-load 10-year version, could also interest many women as a reversible alternative for tubal sterilization. Additional clinical experience with the Gyn-CS IUD is, therefore, urgently warranted.”

No study funding is reported, although Contrel Research provided the Gyn-CS devices at no charge. The study authors reported no relevant disclosures.

SOURCE: Unal C et al. Contraception. 2018 Aug;98:135-40.