Mild traumatic brain injury (TBI) is linked to a significantly increased risk for a host of subsequent cardiovascular, endocrine, neurologic, and psychiatric disorders, new research shows.

Incidence of hypertension, coronary heart disease, diabetes, stroke, depression, and dementia all began to increase soon after the brain injury and persisted over a decade in both mild and moderate to severe TBI.

Researchers found the multisystem comorbidities in all age groups, including in patients as young as 18. They also found that patients who developed multiple postinjury problems had higher mortality during the decade-long follow-up.

The findings suggest patients with TBI may require longer follow-up and proactive screening for multisystem disease, regardless of age or injury severity.

“The fact that both patients with mild and moderate to severe injuries both had long-term ongoing associations with comorbidities that continued over time and that they are cardiovascular, endocrine, neurologic, and behavioral health oriented was pretty striking,” study author Ross Zafonte, DO, PhD, president of Spaulding Rehab Hospital and professor and chair of physical medicine and rehab at Harvard Medical School, both in Boston, told this news organization.

The study was published online in JAMA Network Open.
 

Injury severity not a factor

An estimated 2.8 million individuals in the United States experience TBI every year. Worldwide, the figure may be as high as 74 million.

Studies have long suggested a link between brain injury and subsequent neurologic disorders, but research suggesting a possible link to cardiovascular and endocrine problems has recently gained attention.

Building on a 2021 study that showed increased incidence of cardiovascular issues following a concussion, the researchers examined medical records of previously healthy patients treated for TBI between 2000 and 2015 who also had at least 1 follow-up visit between 6 months and 10 years after the initial injury.

Researchers analyzed data from 13,053 individuals – 4,351 with mild injury (mTBI), 4351 with moderate to severe injury (msTBI), and 4351 with no TBI. The most common cause of injury was a fall. Patients with sports-related injuries were excluded.

Incidence of hypertension was significantly higher among patients with mTBI (hazard ratio, 2.5; 95% confidence interval, 2.1-2.9) and msTBI (HR, 2.4; 95% CI, 2.0-2.9), compared with the unaffected group. Risk for other cardiovascular problems, including hyperlipidemia, obesity, and coronary artery disease, were also higher in the affected groups.

TBI patients also reported higher incidence of endocrine diseases, including diabetes (mTBI: HR, 1.9; 95% CI, 1.4-2.7; msTBI: HR, 1.9; 95% CI, 1.4-2.6). Elevated risk for ischemic stroke or transient ischemic attack was also increased (mTBI: HR, 2.2; 95% CI, 1.4-3.3; msTBI: HR, 3.6; 95% CI, 2.4-5.3).

Regardless of injury severity, patients with TBI had a higher risk for neurologic and psychiatric diseases, particularly depression, dementia, and psychotic disorders. “This tells us that mild TBI is not clean of events,” Dr. Zafonte said.

Surprising rate of comorbidity in youth

Investigators found increased risk for posttrauma comorbidities in all age groups, but researchers were struck by the high rates in younger patients, aged 18-40. Compared with age-matched individuals with no TBI history, hypertension risk was nearly six times higher in those with mTBI (HR, 5.9; 95% CI, 3.9-9.1) and nearly four times higher in patients with msTBI (HR, 3.9; 95% CI, 2.5-6.1).

Rates of hyperlipidemia and diabetes were also higher in younger patients in the mTBI group and posttraumatic seizures and psychiatric disorders were elevated regardless of TBI severity.

Overall, patients with msTBI, but not those with mTBI, were at higher risk for mortality, compared with the unexposed group (432 deaths [9.9%] vs. 250 deaths [5.7%]; P < .001).

“It’s clear that what we may be dealing with is that it holds up even for the younger people,” Dr. Zafonte said. “We used to think brain injury risk is worse in the severe cases, which it is, and it’s worse later on among those who are older, which it is. But our younger folks don’t get away either.”

While the study offers associations between TBI and multisystem health problems, Dr. Zafonte said it’s impossible to say at this point whether the brain injury caused the increased risk for cardiovascular or endocrine problems. Other organ injuries sustained in the trauma may be a contributing factor.

“Further data is needed to elucidate the mechanism and the causative relationships, which we do not have here,” he said.

Many of the postinjury comorbidities emerged a median of 3.5 years after TBI, regardless of severity. But some of the cardiovascular and psychiatric conditions emerged far sooner than that.

That’s important because research suggests less than half of patients with TBI receive follow-up care.

“It does make sense for folks who are interacting with people who’ve had a TBI to be suspicious of medical comorbidities relatively early on, within the first couple of years,” Dr. Zafonte said.

In an invited commentary, Vijay Krishnamoorthy, MD, MPH, PhD, Duke University, Durham, N.C., and Monica S. Vavilala, MD, University of Washington, Seattle, highlight some of the study’s limitations, including a lack of information on comorbidity severity and the lack of a matched group of patients who experienced non-head trauma.

Despite those limitations, the study offers important information on how TBI may affect organs beyond the brain, they noted.

“These observations, if replicated in future studies, raise intriguing implications in the future care of patients with TBI, including heightened chronic disease-screening measures and possibly enhanced guidelines for chronic extracranial organ system care for patients who experience TBI,” Dr. Krishnamoorthy and Dr. Vavilala wrote.

The study received no specific funding. Dr. Zafonte reported having received personal fees from Springer/Demos, serving on scientific advisory boards for Myomo and OnCare and has received funding from the Football Players Health Study at Harvard, funded in part by the National Football League Players Association. Dr. Krishnamoorthy and Dr. Vavilala disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Mild traumatic brain injury (TBI) is linked to a significantly increased risk for a host of subsequent cardiovascular, endocrine, neurologic, and psychiatric disorders, new research shows.

Incidence of hypertension, coronary heart disease, diabetes, stroke, depression, and dementia all began to increase soon after the brain injury and persisted over a decade in both mild and moderate to severe TBI.

Researchers found the multisystem comorbidities in all age groups, including in patients as young as 18. They also found that patients who developed multiple postinjury problems had higher mortality during the decade-long follow-up.

The findings suggest patients with TBI may require longer follow-up and proactive screening for multisystem disease, regardless of age or injury severity.

“The fact that both patients with mild and moderate to severe injuries both had long-term ongoing associations with comorbidities that continued over time and that they are cardiovascular, endocrine, neurologic, and behavioral health oriented was pretty striking,” study author Ross Zafonte, DO, PhD, president of Spaulding Rehab Hospital and professor and chair of physical medicine and rehab at Harvard Medical School, both in Boston, told this news organization.

The study was published online in JAMA Network Open.
 

Injury severity not a factor

An estimated 2.8 million individuals in the United States experience TBI every year. Worldwide, the figure may be as high as 74 million.

Studies have long suggested a link between brain injury and subsequent neurologic disorders, but research suggesting a possible link to cardiovascular and endocrine problems has recently gained attention.

Building on a 2021 study that showed increased incidence of cardiovascular issues following a concussion, the researchers examined medical records of previously healthy patients treated for TBI between 2000 and 2015 who also had at least 1 follow-up visit between 6 months and 10 years after the initial injury.

Researchers analyzed data from 13,053 individuals – 4,351 with mild injury (mTBI), 4351 with moderate to severe injury (msTBI), and 4351 with no TBI. The most common cause of injury was a fall. Patients with sports-related injuries were excluded.

Incidence of hypertension was significantly higher among patients with mTBI (hazard ratio, 2.5; 95% confidence interval, 2.1-2.9) and msTBI (HR, 2.4; 95% CI, 2.0-2.9), compared with the unaffected group. Risk for other cardiovascular problems, including hyperlipidemia, obesity, and coronary artery disease, were also higher in the affected groups.

TBI patients also reported higher incidence of endocrine diseases, including diabetes (mTBI: HR, 1.9; 95% CI, 1.4-2.7; msTBI: HR, 1.9; 95% CI, 1.4-2.6). Elevated risk for ischemic stroke or transient ischemic attack was also increased (mTBI: HR, 2.2; 95% CI, 1.4-3.3; msTBI: HR, 3.6; 95% CI, 2.4-5.3).

Regardless of injury severity, patients with TBI had a higher risk for neurologic and psychiatric diseases, particularly depression, dementia, and psychotic disorders. “This tells us that mild TBI is not clean of events,” Dr. Zafonte said.

Surprising rate of comorbidity in youth

Investigators found increased risk for posttrauma comorbidities in all age groups, but researchers were struck by the high rates in younger patients, aged 18-40. Compared with age-matched individuals with no TBI history, hypertension risk was nearly six times higher in those with mTBI (HR, 5.9; 95% CI, 3.9-9.1) and nearly four times higher in patients with msTBI (HR, 3.9; 95% CI, 2.5-6.1).

Rates of hyperlipidemia and diabetes were also higher in younger patients in the mTBI group and posttraumatic seizures and psychiatric disorders were elevated regardless of TBI severity.

Overall, patients with msTBI, but not those with mTBI, were at higher risk for mortality, compared with the unexposed group (432 deaths [9.9%] vs. 250 deaths [5.7%]; P < .001).

“It’s clear that what we may be dealing with is that it holds up even for the younger people,” Dr. Zafonte said. “We used to think brain injury risk is worse in the severe cases, which it is, and it’s worse later on among those who are older, which it is. But our younger folks don’t get away either.”

While the study offers associations between TBI and multisystem health problems, Dr. Zafonte said it’s impossible to say at this point whether the brain injury caused the increased risk for cardiovascular or endocrine problems. Other organ injuries sustained in the trauma may be a contributing factor.

“Further data is needed to elucidate the mechanism and the causative relationships, which we do not have here,” he said.

Many of the postinjury comorbidities emerged a median of 3.5 years after TBI, regardless of severity. But some of the cardiovascular and psychiatric conditions emerged far sooner than that.

That’s important because research suggests less than half of patients with TBI receive follow-up care.

“It does make sense for folks who are interacting with people who’ve had a TBI to be suspicious of medical comorbidities relatively early on, within the first couple of years,” Dr. Zafonte said.

In an invited commentary, Vijay Krishnamoorthy, MD, MPH, PhD, Duke University, Durham, N.C., and Monica S. Vavilala, MD, University of Washington, Seattle, highlight some of the study’s limitations, including a lack of information on comorbidity severity and the lack of a matched group of patients who experienced non-head trauma.

Despite those limitations, the study offers important information on how TBI may affect organs beyond the brain, they noted.

“These observations, if replicated in future studies, raise intriguing implications in the future care of patients with TBI, including heightened chronic disease-screening measures and possibly enhanced guidelines for chronic extracranial organ system care for patients who experience TBI,” Dr. Krishnamoorthy and Dr. Vavilala wrote.

The study received no specific funding. Dr. Zafonte reported having received personal fees from Springer/Demos, serving on scientific advisory boards for Myomo and OnCare and has received funding from the Football Players Health Study at Harvard, funded in part by the National Football League Players Association. Dr. Krishnamoorthy and Dr. Vavilala disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Mild traumatic brain injury (TBI) is linked to a significantly increased risk for a host of subsequent cardiovascular, endocrine, neurologic, and psychiatric disorders, new research shows.

Incidence of hypertension, coronary heart disease, diabetes, stroke, depression, and dementia all began to increase soon after the brain injury and persisted over a decade in both mild and moderate to severe TBI.

Researchers found the multisystem comorbidities in all age groups, including in patients as young as 18. They also found that patients who developed multiple postinjury problems had higher mortality during the decade-long follow-up.

The findings suggest patients with TBI may require longer follow-up and proactive screening for multisystem disease, regardless of age or injury severity.

“The fact that both patients with mild and moderate to severe injuries both had long-term ongoing associations with comorbidities that continued over time and that they are cardiovascular, endocrine, neurologic, and behavioral health oriented was pretty striking,” study author Ross Zafonte, DO, PhD, president of Spaulding Rehab Hospital and professor and chair of physical medicine and rehab at Harvard Medical School, both in Boston, told this news organization.

The study was published online in JAMA Network Open.
 

Injury severity not a factor

An estimated 2.8 million individuals in the United States experience TBI every year. Worldwide, the figure may be as high as 74 million.

Studies have long suggested a link between brain injury and subsequent neurologic disorders, but research suggesting a possible link to cardiovascular and endocrine problems has recently gained attention.

Building on a 2021 study that showed increased incidence of cardiovascular issues following a concussion, the researchers examined medical records of previously healthy patients treated for TBI between 2000 and 2015 who also had at least 1 follow-up visit between 6 months and 10 years after the initial injury.

Researchers analyzed data from 13,053 individuals – 4,351 with mild injury (mTBI), 4351 with moderate to severe injury (msTBI), and 4351 with no TBI. The most common cause of injury was a fall. Patients with sports-related injuries were excluded.

Incidence of hypertension was significantly higher among patients with mTBI (hazard ratio, 2.5; 95% confidence interval, 2.1-2.9) and msTBI (HR, 2.4; 95% CI, 2.0-2.9), compared with the unaffected group. Risk for other cardiovascular problems, including hyperlipidemia, obesity, and coronary artery disease, were also higher in the affected groups.

TBI patients also reported higher incidence of endocrine diseases, including diabetes (mTBI: HR, 1.9; 95% CI, 1.4-2.7; msTBI: HR, 1.9; 95% CI, 1.4-2.6). Elevated risk for ischemic stroke or transient ischemic attack was also increased (mTBI: HR, 2.2; 95% CI, 1.4-3.3; msTBI: HR, 3.6; 95% CI, 2.4-5.3).

Regardless of injury severity, patients with TBI had a higher risk for neurologic and psychiatric diseases, particularly depression, dementia, and psychotic disorders. “This tells us that mild TBI is not clean of events,” Dr. Zafonte said.

Surprising rate of comorbidity in youth

Investigators found increased risk for posttrauma comorbidities in all age groups, but researchers were struck by the high rates in younger patients, aged 18-40. Compared with age-matched individuals with no TBI history, hypertension risk was nearly six times higher in those with mTBI (HR, 5.9; 95% CI, 3.9-9.1) and nearly four times higher in patients with msTBI (HR, 3.9; 95% CI, 2.5-6.1).

Rates of hyperlipidemia and diabetes were also higher in younger patients in the mTBI group and posttraumatic seizures and psychiatric disorders were elevated regardless of TBI severity.

Overall, patients with msTBI, but not those with mTBI, were at higher risk for mortality, compared with the unexposed group (432 deaths [9.9%] vs. 250 deaths [5.7%]; P < .001).

“It’s clear that what we may be dealing with is that it holds up even for the younger people,” Dr. Zafonte said. “We used to think brain injury risk is worse in the severe cases, which it is, and it’s worse later on among those who are older, which it is. But our younger folks don’t get away either.”

While the study offers associations between TBI and multisystem health problems, Dr. Zafonte said it’s impossible to say at this point whether the brain injury caused the increased risk for cardiovascular or endocrine problems. Other organ injuries sustained in the trauma may be a contributing factor.

“Further data is needed to elucidate the mechanism and the causative relationships, which we do not have here,” he said.

Many of the postinjury comorbidities emerged a median of 3.5 years after TBI, regardless of severity. But some of the cardiovascular and psychiatric conditions emerged far sooner than that.

That’s important because research suggests less than half of patients with TBI receive follow-up care.

“It does make sense for folks who are interacting with people who’ve had a TBI to be suspicious of medical comorbidities relatively early on, within the first couple of years,” Dr. Zafonte said.

In an invited commentary, Vijay Krishnamoorthy, MD, MPH, PhD, Duke University, Durham, N.C., and Monica S. Vavilala, MD, University of Washington, Seattle, highlight some of the study’s limitations, including a lack of information on comorbidity severity and the lack of a matched group of patients who experienced non-head trauma.

Despite those limitations, the study offers important information on how TBI may affect organs beyond the brain, they noted.

“These observations, if replicated in future studies, raise intriguing implications in the future care of patients with TBI, including heightened chronic disease-screening measures and possibly enhanced guidelines for chronic extracranial organ system care for patients who experience TBI,” Dr. Krishnamoorthy and Dr. Vavilala wrote.

The study received no specific funding. Dr. Zafonte reported having received personal fees from Springer/Demos, serving on scientific advisory boards for Myomo and OnCare and has received funding from the Football Players Health Study at Harvard, funded in part by the National Football League Players Association. Dr. Krishnamoorthy and Dr. Vavilala disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

“It was my wife’s walker, and I’ve never used one before. Sorry that I keep bumping into things.”

He was in his early 70s, recently widowed. He hadn’t needed a walker until yesterday, and his son had gotten it out of the garage where they’d just stowed it away. I showed him how to change the height setting on it so he didn’t have to lean so far over.

His daughter was a longstanding patient of mine, and now she and her brother were worried about their dad. He’d been so healthy for years, taking care of their mother as she declined with cancer. Now, 2 months since her death, he’d started going downhill. He’d been, understandably, depressed and had lost some weight. A few weeks ago he’d had some nonspecific upper respiratory crud, and now they were worried he wasn’t eating. He’d gotten progressively weaker in the last few days, leading to their getting out the walker.

I knew my patient for several years. She wasn’t given to panicking, and was worried about her dad. By this time, I was too. Twenty-eight years of neurology training and practice puts you on the edge for some things. The “Spidey Sense,” as I’ve always called it, was tingling.

It took a very quick neurologic exam to find what I needed. He was indeed weak, had decreased distal sensation, and was completely areflexic. It was time to take the most-dreaded outpatient neurology gamble: The direct office-to-ER admission.

I told his daughter to take him to the nearby ER and scribbled a note that said “Probable Guillain-Barré. Needs urgent workup.” They were somewhat taken aback, as they had dinner plans that night, but his daughter knew me well enough to know that I don’t pull fire alarms for fun.

As soon as they’d left I called the ER doctor and told her what was coming. My hospital days ended 2 years ago, but I wanted to do everything I could to make sure the right ball was rolling.

Then my part was over. I had other patients waiting, tests to review, phone calls to make.

This is where the anxiety began. Nobody wants to be the person who cries wolf, or admits “dumps.” I’ve been on both sides of admissions, and bashing outpatient docs for unnecessary hospital referrals is a perennial pastime of inpatient care.

I was sure of my actions, but as the hours crept by some doubt came in. What if he got to the hospital and suddenly wasn’t weak? Or it was all from a medication error he’d made at home?

No one wants to claim they saw a flare when there wasn’t one, or get the reputation of being past their game. I was worried about the patient, but also began to worry I’d screwed up and missed something else.

I finished the day and went home. After closing out my usual end-of-the-day stuff I logged into the hospital system to see what was going on.

Normal cervical spine MRI. Spinal fluid had zero cells and elevated protein.

I breathed a sigh of relief and relaxed back into my chair. I’d made the right call. The hospital neurologist had ordered IVIG. The patient would hopefully recover. No one would think I’d screwed up a potentially serious case. And, somewhere in the back of my mind, the Sherlock Holmes inside every neurologist tipped his deerstalker cap at me and gave a slight nod.

There’s the relief of having done the right thing for the patient, having made the correct diagnosis, and, at the end of the day, being reassured that (some days at least) I still know what I’m doing.

It’s those feelings that brought me here and still keep me going.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

“It was my wife’s walker, and I’ve never used one before. Sorry that I keep bumping into things.”

He was in his early 70s, recently widowed. He hadn’t needed a walker until yesterday, and his son had gotten it out of the garage where they’d just stowed it away. I showed him how to change the height setting on it so he didn’t have to lean so far over.

His daughter was a longstanding patient of mine, and now she and her brother were worried about their dad. He’d been so healthy for years, taking care of their mother as she declined with cancer. Now, 2 months since her death, he’d started going downhill. He’d been, understandably, depressed and had lost some weight. A few weeks ago he’d had some nonspecific upper respiratory crud, and now they were worried he wasn’t eating. He’d gotten progressively weaker in the last few days, leading to their getting out the walker.

I knew my patient for several years. She wasn’t given to panicking, and was worried about her dad. By this time, I was too. Twenty-eight years of neurology training and practice puts you on the edge for some things. The “Spidey Sense,” as I’ve always called it, was tingling.

It took a very quick neurologic exam to find what I needed. He was indeed weak, had decreased distal sensation, and was completely areflexic. It was time to take the most-dreaded outpatient neurology gamble: The direct office-to-ER admission.

I told his daughter to take him to the nearby ER and scribbled a note that said “Probable Guillain-Barré. Needs urgent workup.” They were somewhat taken aback, as they had dinner plans that night, but his daughter knew me well enough to know that I don’t pull fire alarms for fun.

As soon as they’d left I called the ER doctor and told her what was coming. My hospital days ended 2 years ago, but I wanted to do everything I could to make sure the right ball was rolling.

Then my part was over. I had other patients waiting, tests to review, phone calls to make.

This is where the anxiety began. Nobody wants to be the person who cries wolf, or admits “dumps.” I’ve been on both sides of admissions, and bashing outpatient docs for unnecessary hospital referrals is a perennial pastime of inpatient care.

I was sure of my actions, but as the hours crept by some doubt came in. What if he got to the hospital and suddenly wasn’t weak? Or it was all from a medication error he’d made at home?

No one wants to claim they saw a flare when there wasn’t one, or get the reputation of being past their game. I was worried about the patient, but also began to worry I’d screwed up and missed something else.

I finished the day and went home. After closing out my usual end-of-the-day stuff I logged into the hospital system to see what was going on.

Normal cervical spine MRI. Spinal fluid had zero cells and elevated protein.

I breathed a sigh of relief and relaxed back into my chair. I’d made the right call. The hospital neurologist had ordered IVIG. The patient would hopefully recover. No one would think I’d screwed up a potentially serious case. And, somewhere in the back of my mind, the Sherlock Holmes inside every neurologist tipped his deerstalker cap at me and gave a slight nod.

There’s the relief of having done the right thing for the patient, having made the correct diagnosis, and, at the end of the day, being reassured that (some days at least) I still know what I’m doing.

It’s those feelings that brought me here and still keep me going.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

“It was my wife’s walker, and I’ve never used one before. Sorry that I keep bumping into things.”

He was in his early 70s, recently widowed. He hadn’t needed a walker until yesterday, and his son had gotten it out of the garage where they’d just stowed it away. I showed him how to change the height setting on it so he didn’t have to lean so far over.

His daughter was a longstanding patient of mine, and now she and her brother were worried about their dad. He’d been so healthy for years, taking care of their mother as she declined with cancer. Now, 2 months since her death, he’d started going downhill. He’d been, understandably, depressed and had lost some weight. A few weeks ago he’d had some nonspecific upper respiratory crud, and now they were worried he wasn’t eating. He’d gotten progressively weaker in the last few days, leading to their getting out the walker.

I knew my patient for several years. She wasn’t given to panicking, and was worried about her dad. By this time, I was too. Twenty-eight years of neurology training and practice puts you on the edge for some things. The “Spidey Sense,” as I’ve always called it, was tingling.

It took a very quick neurologic exam to find what I needed. He was indeed weak, had decreased distal sensation, and was completely areflexic. It was time to take the most-dreaded outpatient neurology gamble: The direct office-to-ER admission.

I told his daughter to take him to the nearby ER and scribbled a note that said “Probable Guillain-Barré. Needs urgent workup.” They were somewhat taken aback, as they had dinner plans that night, but his daughter knew me well enough to know that I don’t pull fire alarms for fun.

As soon as they’d left I called the ER doctor and told her what was coming. My hospital days ended 2 years ago, but I wanted to do everything I could to make sure the right ball was rolling.

Then my part was over. I had other patients waiting, tests to review, phone calls to make.

This is where the anxiety began. Nobody wants to be the person who cries wolf, or admits “dumps.” I’ve been on both sides of admissions, and bashing outpatient docs for unnecessary hospital referrals is a perennial pastime of inpatient care.

I was sure of my actions, but as the hours crept by some doubt came in. What if he got to the hospital and suddenly wasn’t weak? Or it was all from a medication error he’d made at home?

No one wants to claim they saw a flare when there wasn’t one, or get the reputation of being past their game. I was worried about the patient, but also began to worry I’d screwed up and missed something else.

I finished the day and went home. After closing out my usual end-of-the-day stuff I logged into the hospital system to see what was going on.

Normal cervical spine MRI. Spinal fluid had zero cells and elevated protein.

I breathed a sigh of relief and relaxed back into my chair. I’d made the right call. The hospital neurologist had ordered IVIG. The patient would hopefully recover. No one would think I’d screwed up a potentially serious case. And, somewhere in the back of my mind, the Sherlock Holmes inside every neurologist tipped his deerstalker cap at me and gave a slight nod.

There’s the relief of having done the right thing for the patient, having made the correct diagnosis, and, at the end of the day, being reassured that (some days at least) I still know what I’m doing.

It’s those feelings that brought me here and still keep me going.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

The Food and Drug Administration has approved upadacitinib (Rinvoq) as an oral treatment for active ankylosing spondylitis in adults, its manufacturer AbbVie announced April 29.

Upadacitinib, a selective and reversible Janus kinase inhibitor, is the second drug in its class to be FDA approved for ankylosing spondylitis, after tofacitinib (Xeljanz) in December.

Upadacitinib is now indicated for patients with active ankylosing spondylitis (AS) who have had an insufficient response or intolerance with one or more tumor necrosis factor (TNF) blockers. Upadacitinib is already approved by the FDA for adults with active psoriatic arthritis, moderately to severely active rheumatoid arthritis, and moderately to severely active ulcerative colitis who have had an insufficient response or intolerance with one or more TNF inhibitors. It also has been approved for adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis.

The European Medicines Agency gave marketing approval for upadacitinib in adults with active AS in January 2021.

Two main clinical studies form the basis for the FDA’s approval decision. The phase 3 SELECT-AXIS 2 clinical trial involved patients with an inadequate response or intolerance to one or two biologic disease-modifying antirheumatic drugs (bDMARDs). A total of 44.5% patients with AS who were randomly assigned to upadacitinib 15 mg once daily met the primary endpoint of at least 40% improvement in Assessment in Spondyloarthritis International Society response criteria (ASAS 40) at 14 weeks, compared against 18.2% with placebo.

The second study, the phase 2/3 SELECT-AXIS 1 clinical trial, tested upadacitinib in patients who had never taken bDMARDs and had an inadequate response or intolerance to at least two NSAIDs. In this study, significantly more patients randomly assigned to 15 mg upadacitinib achieved ASAS 40 at 14 weeks, compared with placebo (51% vs. 26%).

Patients randomly assigned to upadacitinib also showed significant improvements in signs and symptoms of AS, as well as improvements in physical function and disease activity, compared with placebo, after 14 weeks. The safety profile for patients with AS treated with upadacitinib was similar to that seen in studies of patients with rheumatoid arthritis or psoriatic arthritis. Potential severe side effects include increased risk for death in patients aged 50 years and older with at least one cardiovascular risk factor; increased risk of serious infections, such as tuberculosis; and increased risk of certain cancers, according to the company statement.

Read the complete prescribing information here.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved upadacitinib (Rinvoq) as an oral treatment for active ankylosing spondylitis in adults, its manufacturer AbbVie announced April 29.

Upadacitinib, a selective and reversible Janus kinase inhibitor, is the second drug in its class to be FDA approved for ankylosing spondylitis, after tofacitinib (Xeljanz) in December.

Upadacitinib is now indicated for patients with active ankylosing spondylitis (AS) who have had an insufficient response or intolerance with one or more tumor necrosis factor (TNF) blockers. Upadacitinib is already approved by the FDA for adults with active psoriatic arthritis, moderately to severely active rheumatoid arthritis, and moderately to severely active ulcerative colitis who have had an insufficient response or intolerance with one or more TNF inhibitors. It also has been approved for adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis.

The European Medicines Agency gave marketing approval for upadacitinib in adults with active AS in January 2021.

Two main clinical studies form the basis for the FDA’s approval decision. The phase 3 SELECT-AXIS 2 clinical trial involved patients with an inadequate response or intolerance to one or two biologic disease-modifying antirheumatic drugs (bDMARDs). A total of 44.5% patients with AS who were randomly assigned to upadacitinib 15 mg once daily met the primary endpoint of at least 40% improvement in Assessment in Spondyloarthritis International Society response criteria (ASAS 40) at 14 weeks, compared against 18.2% with placebo.

The second study, the phase 2/3 SELECT-AXIS 1 clinical trial, tested upadacitinib in patients who had never taken bDMARDs and had an inadequate response or intolerance to at least two NSAIDs. In this study, significantly more patients randomly assigned to 15 mg upadacitinib achieved ASAS 40 at 14 weeks, compared with placebo (51% vs. 26%).

Patients randomly assigned to upadacitinib also showed significant improvements in signs and symptoms of AS, as well as improvements in physical function and disease activity, compared with placebo, after 14 weeks. The safety profile for patients with AS treated with upadacitinib was similar to that seen in studies of patients with rheumatoid arthritis or psoriatic arthritis. Potential severe side effects include increased risk for death in patients aged 50 years and older with at least one cardiovascular risk factor; increased risk of serious infections, such as tuberculosis; and increased risk of certain cancers, according to the company statement.

Read the complete prescribing information here.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved upadacitinib (Rinvoq) as an oral treatment for active ankylosing spondylitis in adults, its manufacturer AbbVie announced April 29.

Upadacitinib, a selective and reversible Janus kinase inhibitor, is the second drug in its class to be FDA approved for ankylosing spondylitis, after tofacitinib (Xeljanz) in December.

Upadacitinib is now indicated for patients with active ankylosing spondylitis (AS) who have had an insufficient response or intolerance with one or more tumor necrosis factor (TNF) blockers. Upadacitinib is already approved by the FDA for adults with active psoriatic arthritis, moderately to severely active rheumatoid arthritis, and moderately to severely active ulcerative colitis who have had an insufficient response or intolerance with one or more TNF inhibitors. It also has been approved for adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis.

The European Medicines Agency gave marketing approval for upadacitinib in adults with active AS in January 2021.

Two main clinical studies form the basis for the FDA’s approval decision. The phase 3 SELECT-AXIS 2 clinical trial involved patients with an inadequate response or intolerance to one or two biologic disease-modifying antirheumatic drugs (bDMARDs). A total of 44.5% patients with AS who were randomly assigned to upadacitinib 15 mg once daily met the primary endpoint of at least 40% improvement in Assessment in Spondyloarthritis International Society response criteria (ASAS 40) at 14 weeks, compared against 18.2% with placebo.

The second study, the phase 2/3 SELECT-AXIS 1 clinical trial, tested upadacitinib in patients who had never taken bDMARDs and had an inadequate response or intolerance to at least two NSAIDs. In this study, significantly more patients randomly assigned to 15 mg upadacitinib achieved ASAS 40 at 14 weeks, compared with placebo (51% vs. 26%).

Patients randomly assigned to upadacitinib also showed significant improvements in signs and symptoms of AS, as well as improvements in physical function and disease activity, compared with placebo, after 14 weeks. The safety profile for patients with AS treated with upadacitinib was similar to that seen in studies of patients with rheumatoid arthritis or psoriatic arthritis. Potential severe side effects include increased risk for death in patients aged 50 years and older with at least one cardiovascular risk factor; increased risk of serious infections, such as tuberculosis; and increased risk of certain cancers, according to the company statement.

Read the complete prescribing information here.

A version of this article first appeared on Medscape.com.

The incidence of sexually transmitted infection (STI) as well as disability-adjusted life-years (DALYs) increased worldwide over 30 years, according to an observational trend study from China.

“Most countries had a decrease in age-standardized rates of incidence and DALY for STIs, whereas the absolute incident cases and DALYs increased from 1990 to 2019,” the authors write in The Lancet Infectious Diseases. “Therefore, STIs still represent a global public health challenge, especially in sub-Saharan Africa and Latin America, where more attention and health prevention services are warranted.”

“Our study also suggested an upward trend of age-standardized incidence rates among young populations, especially for syphilis, after 2010,” they add.
 

STIs are a major worldwide public health challenge

To assess global STI burden and trends, co–lead study author Yang Zheng, MD, of Zhejiang University School of Medicine in Hangzhou, China, and colleagues analyzed data from the Global Burden of Disease (GBD) study 2019.

They calculated incidence and DALYs of STIs in the general population at national, regional, and global levels over 30 years. They also calculated annual percentage changes in the age-standardized incidence rate and the age-standardized DALY rate of the five STIs included in the GBD study.

Of 204 countries in GBD 2019, 161 provided data on syphilis, 64 on gonorrhea, 94 on chlamydia, 56 on trichomonas, and 77 on genital herpes. The authors included 95% uncertainty intervals (UIs) and used Bayesian meta-regression to model the data.

• Overall, they found that the global age-standardized incidence rate of STIs trended downward, with an estimated annual percentage change of –0.04 (95% UI, –0.08 to 0.00) from 1990 to 2019, reaching 9,535.71 per 100,000 person-years (8,169.73-11,054.76) in 2019.
• The age-standardized DALY rate decreased with an estimated annual percentage change of –0.92 (–1.01 to –0.84) and reached 22.74 per 100,000 person-years (14.37-37.11) in 2019.
• Sub-Saharan Africa, one of the hotspots, had the highest age-standardized incidence rate (19,973.12 per 100,000 person-years, 17,382.69-23,001.57) and age-standardized DALY rate (389.32 per 100,000 person-years, 154.27-769.74).
• The highest incidence rate was among adolescents (18,377.82 per 100,000 person-years, 14,040.38-23,443.31), with stable total STI trends except for an increase in syphilis between 2010 (347.65 per 100,000 person-years, 203.58-590.69) and 2019 (423.16 per 100,000 person-years, 235.70-659.01).
• The age-standardized incidence rate was higher among males (10,471.63 per 100,000 person-years, 8,892.20-12,176.10) than females (8,602.40 per 100,000 person-years, 7,358.00-10,001.18), whereas the age-standardized DALY rate was higher among females (33.31 per 100,000 person-years, 21.05-55.25) than males (12.11 per 100,000 person-years, 7.63-18.93).

The authors deliver a call to action

“This paper is a call to action to focus on the STI pandemic with granular data on key target populations,” Yukari C. Manabe, MD, FIDSA, FRCP, who was not involved in the study, told this news organization. “If behavioral messaging and testing in adolescents is not improved, HIV incidence rates will be impacted, and the gains that have been made in this area will be threatened.”

“Although the number of countries from which data could be culled was limited, the change in incident cases is particularly striking, with most countries showing an increase and with African countries showing the largest rise,” said Dr. Manabe, professor of medicine, international health, and molecular microbiology and immunology at Johns Hopkins Medicine and director of the Johns Hopkins Center for Innovative Diagnostics for Infectious Diseases, Baltimore.

“The increase in syphilis incidence rates, particularly in younger people, including men who have sex with men, is also alarming,” she added in an email. “It is interesting to see the gender gap grow as more countries adopt antenatal syphilis screening.”

Ken S. Ho, MD, MPH, infectious diseases specialist and medical director of the Pitt Men’s Study at the University of Pittsburgh School of Medicine, Pennsylvania, called the study’s findings a wake-up call for clinicians to discuss sexual health and wellness with their patients, to increase STI screening, and to address STI stigma.

“Overall, STI rates in most countries have trended down, but paradoxically, the number of cases may be going up, because we have more younger, sexually actively people,” Dr. Ho said in an email.

“The study helps us understand the populations most impacted by STIs and allows us to design and create public health interventions that target the most impacted communities and demographic groups,” Dr. Ho, who also was not involved in the study, added. “It allows us to reflect on how we address disparities. For example, the greater burden of disease seen in women may be due to the fact that women may not be screened and are diagnosed later.”

Dr. Ho explained that the high STI rates in sub-Saharan Africa and Latin America are thought to be due to factors such as poverty and limited access to health care, known drivers of health care disparities.

The 2016 global incidence of common STIs was estimated to be up to 563.3 million, including 6.3 million cases of syphilis, 86.9 million cases of gonorrhea, 127.2 million cases of chlamydia, 156.0 million cases of trichomonas, and 186.9 million cases of genital herpes, the authors write.

The World Health Organization aims to end the STI epidemic by 2030, they note.

The study was funded by Mega-Project of National Science and Technology for the 13th Five-Year Plan of China and the National Natural Science Foundation of China. The authors, Dr. Manabe, and Dr. Ho have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The incidence of sexually transmitted infection (STI) as well as disability-adjusted life-years (DALYs) increased worldwide over 30 years, according to an observational trend study from China.

“Most countries had a decrease in age-standardized rates of incidence and DALY for STIs, whereas the absolute incident cases and DALYs increased from 1990 to 2019,” the authors write in The Lancet Infectious Diseases. “Therefore, STIs still represent a global public health challenge, especially in sub-Saharan Africa and Latin America, where more attention and health prevention services are warranted.”

“Our study also suggested an upward trend of age-standardized incidence rates among young populations, especially for syphilis, after 2010,” they add.
 

STIs are a major worldwide public health challenge

To assess global STI burden and trends, co–lead study author Yang Zheng, MD, of Zhejiang University School of Medicine in Hangzhou, China, and colleagues analyzed data from the Global Burden of Disease (GBD) study 2019.

They calculated incidence and DALYs of STIs in the general population at national, regional, and global levels over 30 years. They also calculated annual percentage changes in the age-standardized incidence rate and the age-standardized DALY rate of the five STIs included in the GBD study.

Of 204 countries in GBD 2019, 161 provided data on syphilis, 64 on gonorrhea, 94 on chlamydia, 56 on trichomonas, and 77 on genital herpes. The authors included 95% uncertainty intervals (UIs) and used Bayesian meta-regression to model the data.

• Overall, they found that the global age-standardized incidence rate of STIs trended downward, with an estimated annual percentage change of –0.04 (95% UI, –0.08 to 0.00) from 1990 to 2019, reaching 9,535.71 per 100,000 person-years (8,169.73-11,054.76) in 2019.
• The age-standardized DALY rate decreased with an estimated annual percentage change of –0.92 (–1.01 to –0.84) and reached 22.74 per 100,000 person-years (14.37-37.11) in 2019.
• Sub-Saharan Africa, one of the hotspots, had the highest age-standardized incidence rate (19,973.12 per 100,000 person-years, 17,382.69-23,001.57) and age-standardized DALY rate (389.32 per 100,000 person-years, 154.27-769.74).
• The highest incidence rate was among adolescents (18,377.82 per 100,000 person-years, 14,040.38-23,443.31), with stable total STI trends except for an increase in syphilis between 2010 (347.65 per 100,000 person-years, 203.58-590.69) and 2019 (423.16 per 100,000 person-years, 235.70-659.01).
• The age-standardized incidence rate was higher among males (10,471.63 per 100,000 person-years, 8,892.20-12,176.10) than females (8,602.40 per 100,000 person-years, 7,358.00-10,001.18), whereas the age-standardized DALY rate was higher among females (33.31 per 100,000 person-years, 21.05-55.25) than males (12.11 per 100,000 person-years, 7.63-18.93).

The authors deliver a call to action

“This paper is a call to action to focus on the STI pandemic with granular data on key target populations,” Yukari C. Manabe, MD, FIDSA, FRCP, who was not involved in the study, told this news organization. “If behavioral messaging and testing in adolescents is not improved, HIV incidence rates will be impacted, and the gains that have been made in this area will be threatened.”

“Although the number of countries from which data could be culled was limited, the change in incident cases is particularly striking, with most countries showing an increase and with African countries showing the largest rise,” said Dr. Manabe, professor of medicine, international health, and molecular microbiology and immunology at Johns Hopkins Medicine and director of the Johns Hopkins Center for Innovative Diagnostics for Infectious Diseases, Baltimore.

“The increase in syphilis incidence rates, particularly in younger people, including men who have sex with men, is also alarming,” she added in an email. “It is interesting to see the gender gap grow as more countries adopt antenatal syphilis screening.”

Ken S. Ho, MD, MPH, infectious diseases specialist and medical director of the Pitt Men’s Study at the University of Pittsburgh School of Medicine, Pennsylvania, called the study’s findings a wake-up call for clinicians to discuss sexual health and wellness with their patients, to increase STI screening, and to address STI stigma.

“Overall, STI rates in most countries have trended down, but paradoxically, the number of cases may be going up, because we have more younger, sexually actively people,” Dr. Ho said in an email.

“The study helps us understand the populations most impacted by STIs and allows us to design and create public health interventions that target the most impacted communities and demographic groups,” Dr. Ho, who also was not involved in the study, added. “It allows us to reflect on how we address disparities. For example, the greater burden of disease seen in women may be due to the fact that women may not be screened and are diagnosed later.”

Dr. Ho explained that the high STI rates in sub-Saharan Africa and Latin America are thought to be due to factors such as poverty and limited access to health care, known drivers of health care disparities.

The 2016 global incidence of common STIs was estimated to be up to 563.3 million, including 6.3 million cases of syphilis, 86.9 million cases of gonorrhea, 127.2 million cases of chlamydia, 156.0 million cases of trichomonas, and 186.9 million cases of genital herpes, the authors write.

The World Health Organization aims to end the STI epidemic by 2030, they note.

The study was funded by Mega-Project of National Science and Technology for the 13th Five-Year Plan of China and the National Natural Science Foundation of China. The authors, Dr. Manabe, and Dr. Ho have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The incidence of sexually transmitted infection (STI) as well as disability-adjusted life-years (DALYs) increased worldwide over 30 years, according to an observational trend study from China.

“Most countries had a decrease in age-standardized rates of incidence and DALY for STIs, whereas the absolute incident cases and DALYs increased from 1990 to 2019,” the authors write in The Lancet Infectious Diseases. “Therefore, STIs still represent a global public health challenge, especially in sub-Saharan Africa and Latin America, where more attention and health prevention services are warranted.”

“Our study also suggested an upward trend of age-standardized incidence rates among young populations, especially for syphilis, after 2010,” they add.
 

STIs are a major worldwide public health challenge

To assess global STI burden and trends, co–lead study author Yang Zheng, MD, of Zhejiang University School of Medicine in Hangzhou, China, and colleagues analyzed data from the Global Burden of Disease (GBD) study 2019.

They calculated incidence and DALYs of STIs in the general population at national, regional, and global levels over 30 years. They also calculated annual percentage changes in the age-standardized incidence rate and the age-standardized DALY rate of the five STIs included in the GBD study.

Of 204 countries in GBD 2019, 161 provided data on syphilis, 64 on gonorrhea, 94 on chlamydia, 56 on trichomonas, and 77 on genital herpes. The authors included 95% uncertainty intervals (UIs) and used Bayesian meta-regression to model the data.

• Overall, they found that the global age-standardized incidence rate of STIs trended downward, with an estimated annual percentage change of –0.04 (95% UI, –0.08 to 0.00) from 1990 to 2019, reaching 9,535.71 per 100,000 person-years (8,169.73-11,054.76) in 2019.
• The age-standardized DALY rate decreased with an estimated annual percentage change of –0.92 (–1.01 to –0.84) and reached 22.74 per 100,000 person-years (14.37-37.11) in 2019.
• Sub-Saharan Africa, one of the hotspots, had the highest age-standardized incidence rate (19,973.12 per 100,000 person-years, 17,382.69-23,001.57) and age-standardized DALY rate (389.32 per 100,000 person-years, 154.27-769.74).
• The highest incidence rate was among adolescents (18,377.82 per 100,000 person-years, 14,040.38-23,443.31), with stable total STI trends except for an increase in syphilis between 2010 (347.65 per 100,000 person-years, 203.58-590.69) and 2019 (423.16 per 100,000 person-years, 235.70-659.01).
• The age-standardized incidence rate was higher among males (10,471.63 per 100,000 person-years, 8,892.20-12,176.10) than females (8,602.40 per 100,000 person-years, 7,358.00-10,001.18), whereas the age-standardized DALY rate was higher among females (33.31 per 100,000 person-years, 21.05-55.25) than males (12.11 per 100,000 person-years, 7.63-18.93).

The authors deliver a call to action

“This paper is a call to action to focus on the STI pandemic with granular data on key target populations,” Yukari C. Manabe, MD, FIDSA, FRCP, who was not involved in the study, told this news organization. “If behavioral messaging and testing in adolescents is not improved, HIV incidence rates will be impacted, and the gains that have been made in this area will be threatened.”

“Although the number of countries from which data could be culled was limited, the change in incident cases is particularly striking, with most countries showing an increase and with African countries showing the largest rise,” said Dr. Manabe, professor of medicine, international health, and molecular microbiology and immunology at Johns Hopkins Medicine and director of the Johns Hopkins Center for Innovative Diagnostics for Infectious Diseases, Baltimore.

“The increase in syphilis incidence rates, particularly in younger people, including men who have sex with men, is also alarming,” she added in an email. “It is interesting to see the gender gap grow as more countries adopt antenatal syphilis screening.”

Ken S. Ho, MD, MPH, infectious diseases specialist and medical director of the Pitt Men’s Study at the University of Pittsburgh School of Medicine, Pennsylvania, called the study’s findings a wake-up call for clinicians to discuss sexual health and wellness with their patients, to increase STI screening, and to address STI stigma.

“Overall, STI rates in most countries have trended down, but paradoxically, the number of cases may be going up, because we have more younger, sexually actively people,” Dr. Ho said in an email.

“The study helps us understand the populations most impacted by STIs and allows us to design and create public health interventions that target the most impacted communities and demographic groups,” Dr. Ho, who also was not involved in the study, added. “It allows us to reflect on how we address disparities. For example, the greater burden of disease seen in women may be due to the fact that women may not be screened and are diagnosed later.”

Dr. Ho explained that the high STI rates in sub-Saharan Africa and Latin America are thought to be due to factors such as poverty and limited access to health care, known drivers of health care disparities.

The 2016 global incidence of common STIs was estimated to be up to 563.3 million, including 6.3 million cases of syphilis, 86.9 million cases of gonorrhea, 127.2 million cases of chlamydia, 156.0 million cases of trichomonas, and 186.9 million cases of genital herpes, the authors write.

The World Health Organization aims to end the STI epidemic by 2030, they note.

The study was funded by Mega-Project of National Science and Technology for the 13th Five-Year Plan of China and the National Natural Science Foundation of China. The authors, Dr. Manabe, and Dr. Ho have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

After several cases of acute hepatitis of unknown origin in children in the United Kingdom were reported, further cases have now been reported in France (two cases), Denmark, Ireland, the Netherlands, and Spain. More than 80 cases have been reported overall, raising fears of an epidemic, according to a press release from the European Centre for Disease Prevention and Control (ECDC).

Furthermore, nine cases have allegedly been reported since last autumn in Alabama in the United States. These cases have mainly been in children aged 1-6 years.

Investigations are ongoing in all these countries, particularly as the “exact causes of these cases of acute hepatitis remain unknown.” Nevertheless, the team working on these cases in the United Kingdom believes that, based on clinical and epidemiologic data, the cause is probably infectious in origin.

Coordinated by the ECDC, European medical societies such as the European Association for the Study of the Liver and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) are working together to promote information sharing, according to the European agency.
 

Potential infectious agent

For context, on April 5, the United Kingdom reported about 10 cases of acute hepatitis of unknown origin in children younger than 10 in Scotland with no underlying conditions. Seven days later, the UK reported that 61 additional cases were under investigation in England, Wales, and Northern Ireland, the majority of which were in children aged 2-5 years.

The cases in the United Kingdom presented with severe acute hepatitis, with increased liver enzyme levels (aspartate aminotransferase [AST] and alanine aminotransferase [ALT] levels above 500 IU/L), and most presented with jaundice. Some reported gastrointestinal symptoms such as abdominal pain, diarrhea, and vomiting in the previous weeks.

The majority had no fever.

Although no deaths had been reported at press time, some cases needed to be seen by a liver specialist in the hospital, and others had to undergo transplantation (six transplants in Europe and two in the United States).

Initial hypotheses have focused on a potential infectious agent or exposure to a toxin. No link to COVID-19 vaccination has been established.
 

Which type of hepatitis?

The ECDC reports that laboratory tests have ruled out the possibility of attributing the cases to type A, B, C, D, and E viral hepatitis. Of the 13 cases in Scotland, 3 tested positive for SARS-CoV-2, 5 were negative, and 2 had contracted COVID-19 over the course of the last 3 months.

One positive test for adenovirus was found in 5 of the 13 Scottish cases, out of the 11 that were tested. All the cases reported in the United States tested positive for an adenovirus, five of which were for adenovirus type 41, which is responsible for inflammation of the bowel. Investigations are ongoing to assess any possible involvement of this virus in other cases. It should be noted that adenoviruses can cause hepatitis in children, but generally only in those who are immunosuppressed.

The pandemic could be another possible explanation, Nancy Reau, MD, head of the hepatology department at Rush University, Chicago, told this news organization. “The possibility that these cases are linked to COVID still exists,” she said. Some cases in the United Kingdom tested positive for COVID-19; none of these children had received the COVID-19 vaccine.

“COVID has been regularly seen to raise liver markers. It has also been shown to affect organs other than the lungs,” she stated. “It could be the case that, as it evolves, this virus has the potential to cause hepatitis in children.”

A version of this article first appeared on Medscape.com.

After several cases of acute hepatitis of unknown origin in children in the United Kingdom were reported, further cases have now been reported in France (two cases), Denmark, Ireland, the Netherlands, and Spain. More than 80 cases have been reported overall, raising fears of an epidemic, according to a press release from the European Centre for Disease Prevention and Control (ECDC).

Furthermore, nine cases have allegedly been reported since last autumn in Alabama in the United States. These cases have mainly been in children aged 1-6 years.

Investigations are ongoing in all these countries, particularly as the “exact causes of these cases of acute hepatitis remain unknown.” Nevertheless, the team working on these cases in the United Kingdom believes that, based on clinical and epidemiologic data, the cause is probably infectious in origin.

Coordinated by the ECDC, European medical societies such as the European Association for the Study of the Liver and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) are working together to promote information sharing, according to the European agency.
 

Potential infectious agent

For context, on April 5, the United Kingdom reported about 10 cases of acute hepatitis of unknown origin in children younger than 10 in Scotland with no underlying conditions. Seven days later, the UK reported that 61 additional cases were under investigation in England, Wales, and Northern Ireland, the majority of which were in children aged 2-5 years.

The cases in the United Kingdom presented with severe acute hepatitis, with increased liver enzyme levels (aspartate aminotransferase [AST] and alanine aminotransferase [ALT] levels above 500 IU/L), and most presented with jaundice. Some reported gastrointestinal symptoms such as abdominal pain, diarrhea, and vomiting in the previous weeks.

The majority had no fever.

Although no deaths had been reported at press time, some cases needed to be seen by a liver specialist in the hospital, and others had to undergo transplantation (six transplants in Europe and two in the United States).

Initial hypotheses have focused on a potential infectious agent or exposure to a toxin. No link to COVID-19 vaccination has been established.
 

Which type of hepatitis?

The ECDC reports that laboratory tests have ruled out the possibility of attributing the cases to type A, B, C, D, and E viral hepatitis. Of the 13 cases in Scotland, 3 tested positive for SARS-CoV-2, 5 were negative, and 2 had contracted COVID-19 over the course of the last 3 months.

One positive test for adenovirus was found in 5 of the 13 Scottish cases, out of the 11 that were tested. All the cases reported in the United States tested positive for an adenovirus, five of which were for adenovirus type 41, which is responsible for inflammation of the bowel. Investigations are ongoing to assess any possible involvement of this virus in other cases. It should be noted that adenoviruses can cause hepatitis in children, but generally only in those who are immunosuppressed.

The pandemic could be another possible explanation, Nancy Reau, MD, head of the hepatology department at Rush University, Chicago, told this news organization. “The possibility that these cases are linked to COVID still exists,” she said. Some cases in the United Kingdom tested positive for COVID-19; none of these children had received the COVID-19 vaccine.

“COVID has been regularly seen to raise liver markers. It has also been shown to affect organs other than the lungs,” she stated. “It could be the case that, as it evolves, this virus has the potential to cause hepatitis in children.”

A version of this article first appeared on Medscape.com.

After several cases of acute hepatitis of unknown origin in children in the United Kingdom were reported, further cases have now been reported in France (two cases), Denmark, Ireland, the Netherlands, and Spain. More than 80 cases have been reported overall, raising fears of an epidemic, according to a press release from the European Centre for Disease Prevention and Control (ECDC).

Furthermore, nine cases have allegedly been reported since last autumn in Alabama in the United States. These cases have mainly been in children aged 1-6 years.

Investigations are ongoing in all these countries, particularly as the “exact causes of these cases of acute hepatitis remain unknown.” Nevertheless, the team working on these cases in the United Kingdom believes that, based on clinical and epidemiologic data, the cause is probably infectious in origin.

Coordinated by the ECDC, European medical societies such as the European Association for the Study of the Liver and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) are working together to promote information sharing, according to the European agency.
 

Potential infectious agent

For context, on April 5, the United Kingdom reported about 10 cases of acute hepatitis of unknown origin in children younger than 10 in Scotland with no underlying conditions. Seven days later, the UK reported that 61 additional cases were under investigation in England, Wales, and Northern Ireland, the majority of which were in children aged 2-5 years.

The cases in the United Kingdom presented with severe acute hepatitis, with increased liver enzyme levels (aspartate aminotransferase [AST] and alanine aminotransferase [ALT] levels above 500 IU/L), and most presented with jaundice. Some reported gastrointestinal symptoms such as abdominal pain, diarrhea, and vomiting in the previous weeks.

The majority had no fever.

Although no deaths had been reported at press time, some cases needed to be seen by a liver specialist in the hospital, and others had to undergo transplantation (six transplants in Europe and two in the United States).

Initial hypotheses have focused on a potential infectious agent or exposure to a toxin. No link to COVID-19 vaccination has been established.
 

Which type of hepatitis?

The ECDC reports that laboratory tests have ruled out the possibility of attributing the cases to type A, B, C, D, and E viral hepatitis. Of the 13 cases in Scotland, 3 tested positive for SARS-CoV-2, 5 were negative, and 2 had contracted COVID-19 over the course of the last 3 months.

One positive test for adenovirus was found in 5 of the 13 Scottish cases, out of the 11 that were tested. All the cases reported in the United States tested positive for an adenovirus, five of which were for adenovirus type 41, which is responsible for inflammation of the bowel. Investigations are ongoing to assess any possible involvement of this virus in other cases. It should be noted that adenoviruses can cause hepatitis in children, but generally only in those who are immunosuppressed.

The pandemic could be another possible explanation, Nancy Reau, MD, head of the hepatology department at Rush University, Chicago, told this news organization. “The possibility that these cases are linked to COVID still exists,” she said. Some cases in the United Kingdom tested positive for COVID-19; none of these children had received the COVID-19 vaccine.

“COVID has been regularly seen to raise liver markers. It has also been shown to affect organs other than the lungs,” she stated. “It could be the case that, as it evolves, this virus has the potential to cause hepatitis in children.”

A version of this article first appeared on Medscape.com.

LISBON – Screening for Staphylococcus aureus, decolonization, and use of teicoplanin for surgical antimicrobial prophylaxis among patients with methicillin-resistant S. aureus (MRSA) lowered the number of prosthetic joint infections in elderly patients undergoing surgery for fracture of the femur.

The findings were presented in a poster at the 32nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) 2022, which was one of the few awarded the accolade of “top-rated poster.”

“We actually found that with our intervention, all prosthetic joint infections decreased, not just the Staphylococcus aureus but those due to MRSA, too,” Natividad Benito, MD, an infectious diseases specialist at Hospital de la Santa Creu i Sant Pau in Barcelona, said in an interview. “We’re pleased with these results because prosthetic joint infections present such a complicated situation for patients and surgeons. This is also a relatively easy intervention to use, and with time, even the PCR [polymerase chain reaction] technology will become cheaper. Now, in our hospital, prosthetic joint infections are rare.”

At Hospital de la Santa Creu i Sant Pau, around 200 hip hemiarthroplasties are performed per year. Preceding the intervention, the hospital recorded 11 prosthetic joint infections, with up to five infections due to S. aureus and up to four due to MRSA.

The intervention was introduced in 2016. After 2 years, there were no cases of prosthetic joint infections due to S. aureus; in 2018 there, was one case of prosthetic joint infection due to MRSA. In 2019, there was one case of prosthetic joint infection, but it was due neither to S. aureus nor MRSA. In 2020 and 2021, there was one infection each year that was due to MRSA.

Jesús Rodríguez Baño, MD, head of the infectious diseases division, Hospital Universitario Virgen Macarena at the University of Seville, Spain, who was not involved in the study, explained that for patients with hip fracture, “the time frame in which colonization can be studied is too short using traditional methods. Prosthetic joint infections in this population have a devastating effect, with not negligible mortality and very important morbidity and health care costs.”

Referring to the significant reduction in the rate of S. aureus prosthetic joint infections in the postintervention period, Dr. Rodríguez Baño said in an interview, “The results are sound, and the important reduction in infection risk invites for the development of a multicenter, randomized trial to confirm these interesting results.

“The authors are commended for measuring the impact of applying a well-justified preventive protocol,” Dr. Rodríguez Baño added. However, the study has some limitations: “It was performed in one center, it was not randomized, and control for potential confounders is needed.”
 

Decolonization in an emergency femur fracture

This study addressed a particular need in residents of Spain’s long-term care facilities. In 2016, the prevalence of MRSA was high.

Roughly one-third of the general population carry S. aureus in their noses. In care homes, the rate of MRSA is higher than in the general population, at around 30% of those with S. aureus. In Spain, recommendations for patients undergoing elective total joint arthroplasty advise S. aureus decolonization – which can take 5 days – to prevent surgical site infections.

“The problem with the elderly population is not only have they a higher incidence of MRSA but that the surgical prophylaxis is inadequate for MRSA,” Dr. Benito pointed out.

Many patients in long-term care facilities are elderly and frail and are at greater risk of fracture. Unlike elective hip surgery, in which patients are asked to undergo decolonization over the 5 days prior to their operation, with emergent femur fractures, there is insufficient time for such preparation. “These patients with femur fractures need surgery as soon as possible,” said Dr. Benito.

No studies have been conducted to determine the best way to minimize infection risk from S. aureus and MRSA for patients undergoing emergency hip hemiarthroplasty surgery to treat femoral fractures.

In the current study, Dr. Benito and coauthors assessed whether a bundle of measures – including rapid detection of S. aureus nasal carriage by PCR upon arrival in the emergency setting, followed by decolonization of carriers using a topical treatment in the nose and a prescription of surgical antimicrobial prophylaxis (adapted antibiotic prophylaxis for MRSA) – reduces the incidence of prosthetic joint infections after surgery.

The quasi-experimental single-center study included patients admitted to the emergency department at Hospital de la Santa Creu i Sant Pau. The PCR was rapid, with a turnaround of just 1.5 hours. Decolonization of S. aureus carriers was carried out using nasal mupirocin and chlorhexidine gluconate bathing, which was started immediately. It was used for a 5 days and was usually continued throughout and after surgery.

Patients carrying MRSA received teicoplanin as optimal surgical antimicrobial prophylaxis instead of cefazolin. The intervention did not interfere with the timing of surgery. The study’s principal outcomes were overall incidence of prosthetic joint infections and the incidence of those specifically caused by S. aureus and MRSA.

The researchers compared findings regarding these outcomes over 5 consecutive years of the intervention to outcomes during 4 consecutive years prior to the intervention, which started in 2016.

During 2016-2020, from 22% to 31% of the overall number of patients requiring hip hemiarthroplasty were referred from long-term care facilities. From 25% to 29% of these patients tested positive for S. aureus on PCR, and of these, 33%-64% had MRSA.

There were 772 surgical procedures from 2012 to 2015 and 786 from 2017 to 2020.

Prior to the intervention, over the years 2012-2014, S. aureus caused 36%-50% of prosthetic joint infections; 25%-100% of the S. aureus infections were MRSA. This decreased significantly after the intervention.

During 2016-2020, there was an average of 14 prosthetic joint infections (1.5%), compared to 36 (4.7%) in 2012-2015 (P < .001). Similarly, the incidence of prosthetic joint infections due to S. aureus dropped to 0.3% from 1.8% (P < .002). The incidence of MRSA prosthetic joint infections was 0.3% for 2016-2020, versus 1.2% for 2012-2015 (P = .012).

The years 2018, 2020, and 2021 each saw one case of infection due to MRSA. They were most likely due to “the intervention not being performed properly in all cases,” said Dr. Benito.

A prosthetic joint infection is very serious for the patient. “It means reoperating, because antibiotics are not enough to clear the infection. The biofilm and pus of the infection need to be cleaned out, a new prosthesis is needed, after which more antibiotics are needed for around 2 months, which can be hard to tolerate, and even then, the infection might not be eradicated,” explained Dr. Benito. “Many of these people are old and frail, and mortality can be significant. Getting a prosthetic joint infection is catastrophic for these patients.”

Dr. Benito and Dr. Rodríguez-Baño have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

LISBON – Screening for Staphylococcus aureus, decolonization, and use of teicoplanin for surgical antimicrobial prophylaxis among patients with methicillin-resistant S. aureus (MRSA) lowered the number of prosthetic joint infections in elderly patients undergoing surgery for fracture of the femur.

The findings were presented in a poster at the 32nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) 2022, which was one of the few awarded the accolade of “top-rated poster.”

“We actually found that with our intervention, all prosthetic joint infections decreased, not just the Staphylococcus aureus but those due to MRSA, too,” Natividad Benito, MD, an infectious diseases specialist at Hospital de la Santa Creu i Sant Pau in Barcelona, said in an interview. “We’re pleased with these results because prosthetic joint infections present such a complicated situation for patients and surgeons. This is also a relatively easy intervention to use, and with time, even the PCR [polymerase chain reaction] technology will become cheaper. Now, in our hospital, prosthetic joint infections are rare.”

At Hospital de la Santa Creu i Sant Pau, around 200 hip hemiarthroplasties are performed per year. Preceding the intervention, the hospital recorded 11 prosthetic joint infections, with up to five infections due to S. aureus and up to four due to MRSA.

The intervention was introduced in 2016. After 2 years, there were no cases of prosthetic joint infections due to S. aureus; in 2018 there, was one case of prosthetic joint infection due to MRSA. In 2019, there was one case of prosthetic joint infection, but it was due neither to S. aureus nor MRSA. In 2020 and 2021, there was one infection each year that was due to MRSA.

Jesús Rodríguez Baño, MD, head of the infectious diseases division, Hospital Universitario Virgen Macarena at the University of Seville, Spain, who was not involved in the study, explained that for patients with hip fracture, “the time frame in which colonization can be studied is too short using traditional methods. Prosthetic joint infections in this population have a devastating effect, with not negligible mortality and very important morbidity and health care costs.”

Referring to the significant reduction in the rate of S. aureus prosthetic joint infections in the postintervention period, Dr. Rodríguez Baño said in an interview, “The results are sound, and the important reduction in infection risk invites for the development of a multicenter, randomized trial to confirm these interesting results.

“The authors are commended for measuring the impact of applying a well-justified preventive protocol,” Dr. Rodríguez Baño added. However, the study has some limitations: “It was performed in one center, it was not randomized, and control for potential confounders is needed.”
 

Decolonization in an emergency femur fracture

This study addressed a particular need in residents of Spain’s long-term care facilities. In 2016, the prevalence of MRSA was high.

Roughly one-third of the general population carry S. aureus in their noses. In care homes, the rate of MRSA is higher than in the general population, at around 30% of those with S. aureus. In Spain, recommendations for patients undergoing elective total joint arthroplasty advise S. aureus decolonization – which can take 5 days – to prevent surgical site infections.

“The problem with the elderly population is not only have they a higher incidence of MRSA but that the surgical prophylaxis is inadequate for MRSA,” Dr. Benito pointed out.

Many patients in long-term care facilities are elderly and frail and are at greater risk of fracture. Unlike elective hip surgery, in which patients are asked to undergo decolonization over the 5 days prior to their operation, with emergent femur fractures, there is insufficient time for such preparation. “These patients with femur fractures need surgery as soon as possible,” said Dr. Benito.

No studies have been conducted to determine the best way to minimize infection risk from S. aureus and MRSA for patients undergoing emergency hip hemiarthroplasty surgery to treat femoral fractures.

In the current study, Dr. Benito and coauthors assessed whether a bundle of measures – including rapid detection of S. aureus nasal carriage by PCR upon arrival in the emergency setting, followed by decolonization of carriers using a topical treatment in the nose and a prescription of surgical antimicrobial prophylaxis (adapted antibiotic prophylaxis for MRSA) – reduces the incidence of prosthetic joint infections after surgery.

The quasi-experimental single-center study included patients admitted to the emergency department at Hospital de la Santa Creu i Sant Pau. The PCR was rapid, with a turnaround of just 1.5 hours. Decolonization of S. aureus carriers was carried out using nasal mupirocin and chlorhexidine gluconate bathing, which was started immediately. It was used for a 5 days and was usually continued throughout and after surgery.

Patients carrying MRSA received teicoplanin as optimal surgical antimicrobial prophylaxis instead of cefazolin. The intervention did not interfere with the timing of surgery. The study’s principal outcomes were overall incidence of prosthetic joint infections and the incidence of those specifically caused by S. aureus and MRSA.

The researchers compared findings regarding these outcomes over 5 consecutive years of the intervention to outcomes during 4 consecutive years prior to the intervention, which started in 2016.

During 2016-2020, from 22% to 31% of the overall number of patients requiring hip hemiarthroplasty were referred from long-term care facilities. From 25% to 29% of these patients tested positive for S. aureus on PCR, and of these, 33%-64% had MRSA.

There were 772 surgical procedures from 2012 to 2015 and 786 from 2017 to 2020.

Prior to the intervention, over the years 2012-2014, S. aureus caused 36%-50% of prosthetic joint infections; 25%-100% of the S. aureus infections were MRSA. This decreased significantly after the intervention.

During 2016-2020, there was an average of 14 prosthetic joint infections (1.5%), compared to 36 (4.7%) in 2012-2015 (P < .001). Similarly, the incidence of prosthetic joint infections due to S. aureus dropped to 0.3% from 1.8% (P < .002). The incidence of MRSA prosthetic joint infections was 0.3% for 2016-2020, versus 1.2% for 2012-2015 (P = .012).

The years 2018, 2020, and 2021 each saw one case of infection due to MRSA. They were most likely due to “the intervention not being performed properly in all cases,” said Dr. Benito.

A prosthetic joint infection is very serious for the patient. “It means reoperating, because antibiotics are not enough to clear the infection. The biofilm and pus of the infection need to be cleaned out, a new prosthesis is needed, after which more antibiotics are needed for around 2 months, which can be hard to tolerate, and even then, the infection might not be eradicated,” explained Dr. Benito. “Many of these people are old and frail, and mortality can be significant. Getting a prosthetic joint infection is catastrophic for these patients.”

Dr. Benito and Dr. Rodríguez-Baño have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

LISBON – Screening for Staphylococcus aureus, decolonization, and use of teicoplanin for surgical antimicrobial prophylaxis among patients with methicillin-resistant S. aureus (MRSA) lowered the number of prosthetic joint infections in elderly patients undergoing surgery for fracture of the femur.

The findings were presented in a poster at the 32nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) 2022, which was one of the few awarded the accolade of “top-rated poster.”

“We actually found that with our intervention, all prosthetic joint infections decreased, not just the Staphylococcus aureus but those due to MRSA, too,” Natividad Benito, MD, an infectious diseases specialist at Hospital de la Santa Creu i Sant Pau in Barcelona, said in an interview. “We’re pleased with these results because prosthetic joint infections present such a complicated situation for patients and surgeons. This is also a relatively easy intervention to use, and with time, even the PCR [polymerase chain reaction] technology will become cheaper. Now, in our hospital, prosthetic joint infections are rare.”

At Hospital de la Santa Creu i Sant Pau, around 200 hip hemiarthroplasties are performed per year. Preceding the intervention, the hospital recorded 11 prosthetic joint infections, with up to five infections due to S. aureus and up to four due to MRSA.

The intervention was introduced in 2016. After 2 years, there were no cases of prosthetic joint infections due to S. aureus; in 2018 there, was one case of prosthetic joint infection due to MRSA. In 2019, there was one case of prosthetic joint infection, but it was due neither to S. aureus nor MRSA. In 2020 and 2021, there was one infection each year that was due to MRSA.

Jesús Rodríguez Baño, MD, head of the infectious diseases division, Hospital Universitario Virgen Macarena at the University of Seville, Spain, who was not involved in the study, explained that for patients with hip fracture, “the time frame in which colonization can be studied is too short using traditional methods. Prosthetic joint infections in this population have a devastating effect, with not negligible mortality and very important morbidity and health care costs.”

Referring to the significant reduction in the rate of S. aureus prosthetic joint infections in the postintervention period, Dr. Rodríguez Baño said in an interview, “The results are sound, and the important reduction in infection risk invites for the development of a multicenter, randomized trial to confirm these interesting results.

“The authors are commended for measuring the impact of applying a well-justified preventive protocol,” Dr. Rodríguez Baño added. However, the study has some limitations: “It was performed in one center, it was not randomized, and control for potential confounders is needed.”
 

Decolonization in an emergency femur fracture

This study addressed a particular need in residents of Spain’s long-term care facilities. In 2016, the prevalence of MRSA was high.

Roughly one-third of the general population carry S. aureus in their noses. In care homes, the rate of MRSA is higher than in the general population, at around 30% of those with S. aureus. In Spain, recommendations for patients undergoing elective total joint arthroplasty advise S. aureus decolonization – which can take 5 days – to prevent surgical site infections.

“The problem with the elderly population is not only have they a higher incidence of MRSA but that the surgical prophylaxis is inadequate for MRSA,” Dr. Benito pointed out.

Many patients in long-term care facilities are elderly and frail and are at greater risk of fracture. Unlike elective hip surgery, in which patients are asked to undergo decolonization over the 5 days prior to their operation, with emergent femur fractures, there is insufficient time for such preparation. “These patients with femur fractures need surgery as soon as possible,” said Dr. Benito.

No studies have been conducted to determine the best way to minimize infection risk from S. aureus and MRSA for patients undergoing emergency hip hemiarthroplasty surgery to treat femoral fractures.

In the current study, Dr. Benito and coauthors assessed whether a bundle of measures – including rapid detection of S. aureus nasal carriage by PCR upon arrival in the emergency setting, followed by decolonization of carriers using a topical treatment in the nose and a prescription of surgical antimicrobial prophylaxis (adapted antibiotic prophylaxis for MRSA) – reduces the incidence of prosthetic joint infections after surgery.

The quasi-experimental single-center study included patients admitted to the emergency department at Hospital de la Santa Creu i Sant Pau. The PCR was rapid, with a turnaround of just 1.5 hours. Decolonization of S. aureus carriers was carried out using nasal mupirocin and chlorhexidine gluconate bathing, which was started immediately. It was used for a 5 days and was usually continued throughout and after surgery.

Patients carrying MRSA received teicoplanin as optimal surgical antimicrobial prophylaxis instead of cefazolin. The intervention did not interfere with the timing of surgery. The study’s principal outcomes were overall incidence of prosthetic joint infections and the incidence of those specifically caused by S. aureus and MRSA.

The researchers compared findings regarding these outcomes over 5 consecutive years of the intervention to outcomes during 4 consecutive years prior to the intervention, which started in 2016.

During 2016-2020, from 22% to 31% of the overall number of patients requiring hip hemiarthroplasty were referred from long-term care facilities. From 25% to 29% of these patients tested positive for S. aureus on PCR, and of these, 33%-64% had MRSA.

There were 772 surgical procedures from 2012 to 2015 and 786 from 2017 to 2020.

Prior to the intervention, over the years 2012-2014, S. aureus caused 36%-50% of prosthetic joint infections; 25%-100% of the S. aureus infections were MRSA. This decreased significantly after the intervention.

During 2016-2020, there was an average of 14 prosthetic joint infections (1.5%), compared to 36 (4.7%) in 2012-2015 (P < .001). Similarly, the incidence of prosthetic joint infections due to S. aureus dropped to 0.3% from 1.8% (P < .002). The incidence of MRSA prosthetic joint infections was 0.3% for 2016-2020, versus 1.2% for 2012-2015 (P = .012).

The years 2018, 2020, and 2021 each saw one case of infection due to MRSA. They were most likely due to “the intervention not being performed properly in all cases,” said Dr. Benito.

A prosthetic joint infection is very serious for the patient. “It means reoperating, because antibiotics are not enough to clear the infection. The biofilm and pus of the infection need to be cleaned out, a new prosthesis is needed, after which more antibiotics are needed for around 2 months, which can be hard to tolerate, and even then, the infection might not be eradicated,” explained Dr. Benito. “Many of these people are old and frail, and mortality can be significant. Getting a prosthetic joint infection is catastrophic for these patients.”

Dr. Benito and Dr. Rodríguez-Baño have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Results of a meta-analysis carried out by a French team indicate that there is a link between a father’s or mother’s autoimmune disease and their children’s risk of developing certain neurodevelopmental disorders (autism spectrum disorder [ASD] and attention-deficit/hyperactivity disorder). This meta-analysis is the first to separately explore the link between a father’s or mother’s autoimmune disease and the onset of neurodevelopmental disorders in their children.

According to its authors, these associations may result from exposure to environmental factors that contribute to autoimmune disorders, such as exposure to pollutants or cigarette smoke, and/or genetic predisposition, including genes relating to cytokines or to the HLA system.

Research is needed to determine the pathophysiologic links between these associations. This study suggests that there could be a shared mechanism between both parents, even though the maternal route seems to constitute an additional excess risk.
 

Why is this important?

Neurodevelopmental disorders are said to occur because of a close interrelationship between a person’s genes and environment. Immune-mediated adverse reactions may play an important role in triggering such disorders, as has been shown in associated epidemiologic studies and in animal studies. Autoimmune and autoinflammatory disorders are effectively characterized by the activation of the immune system, the circulation of autoantibodies, and the secretion of cytokines that are harmful to certain tissues.

Some relevant studies suggest a link between autoimmune disorders in the family or in the mother and the onset of neurodevelopmental disorders in their children. However, none of the studies have distinguished the influence of each of the parents so as to provide data that can be used to assess whether this association is more likely to be direct, and thus established during pregnancy, or rather genetic or environmental.
 

Main findings

Overall, the meta-analysis involved 14 studies that included 845,411 mothers and 601,148 fathers with an autoimmune disease, 4,984,965 control mothers and 4,992,854 control fathers. There were 182,927 children with neurodevelopmental disorders and 14,168,474 with no such diagnosis.

Globally, autoimmune diseases in mothers (adjusted odds ratio, 1.27 [1.03-1.57]; P = .02; I2 = 65%) and in fathers (AOR, 1.18 [1.07-1.30]; P = .01; I2 = 15.5%) are associated with a diagnosis of ASD in children. Similarly, they are associated with an increased risk of ADHD in children (AOR, 1.31 [1.11-1.55]; P = .001; I2 = 93% and AOR, 1.14 [1.10-1.17]; P < .0001; I2 = 0%, respectively, for mothers and fathers).

In mothers, type 1 diabetes (AOR, 1.60 [1.18-2.18]; P = .002; I2 = 0%), psoriasis (AOR, 1.45 [1.14-1.85]; P = .002; I2 = 0%), and rheumatoid arthritis (AOR, 1.38 [1.14-1.68]; P = .001; I2 = 0.8%) were associated with a risk of ASD in children. These three conditions also predisposed children to the risk of ADHD (AOR, 1.36 [1.24-1.52]; 1.41 [1.29-1.54]; and 1.32 [1.25-1.40], respectively, all P < .0001).

In fathers, type 1 diabetes considered in isolation was associated with a risk of ASD and ADHD in children (AOR, 1.42 [1.10-1.83] and 1.19 [1.08-1.31], respectively), while psoriasis (AOR, 1.18 [1.12-1.24]; P < .0001) is associated with a risk of ADHD in children.

A version of this article first appeared on Medscape.com.

Results of a meta-analysis carried out by a French team indicate that there is a link between a father’s or mother’s autoimmune disease and their children’s risk of developing certain neurodevelopmental disorders (autism spectrum disorder [ASD] and attention-deficit/hyperactivity disorder). This meta-analysis is the first to separately explore the link between a father’s or mother’s autoimmune disease and the onset of neurodevelopmental disorders in their children.

According to its authors, these associations may result from exposure to environmental factors that contribute to autoimmune disorders, such as exposure to pollutants or cigarette smoke, and/or genetic predisposition, including genes relating to cytokines or to the HLA system.

Research is needed to determine the pathophysiologic links between these associations. This study suggests that there could be a shared mechanism between both parents, even though the maternal route seems to constitute an additional excess risk.
 

Why is this important?

Neurodevelopmental disorders are said to occur because of a close interrelationship between a person’s genes and environment. Immune-mediated adverse reactions may play an important role in triggering such disorders, as has been shown in associated epidemiologic studies and in animal studies. Autoimmune and autoinflammatory disorders are effectively characterized by the activation of the immune system, the circulation of autoantibodies, and the secretion of cytokines that are harmful to certain tissues.

Some relevant studies suggest a link between autoimmune disorders in the family or in the mother and the onset of neurodevelopmental disorders in their children. However, none of the studies have distinguished the influence of each of the parents so as to provide data that can be used to assess whether this association is more likely to be direct, and thus established during pregnancy, or rather genetic or environmental.
 

Main findings

Overall, the meta-analysis involved 14 studies that included 845,411 mothers and 601,148 fathers with an autoimmune disease, 4,984,965 control mothers and 4,992,854 control fathers. There were 182,927 children with neurodevelopmental disorders and 14,168,474 with no such diagnosis.

Globally, autoimmune diseases in mothers (adjusted odds ratio, 1.27 [1.03-1.57]; P = .02; I2 = 65%) and in fathers (AOR, 1.18 [1.07-1.30]; P = .01; I2 = 15.5%) are associated with a diagnosis of ASD in children. Similarly, they are associated with an increased risk of ADHD in children (AOR, 1.31 [1.11-1.55]; P = .001; I2 = 93% and AOR, 1.14 [1.10-1.17]; P < .0001; I2 = 0%, respectively, for mothers and fathers).

In mothers, type 1 diabetes (AOR, 1.60 [1.18-2.18]; P = .002; I2 = 0%), psoriasis (AOR, 1.45 [1.14-1.85]; P = .002; I2 = 0%), and rheumatoid arthritis (AOR, 1.38 [1.14-1.68]; P = .001; I2 = 0.8%) were associated with a risk of ASD in children. These three conditions also predisposed children to the risk of ADHD (AOR, 1.36 [1.24-1.52]; 1.41 [1.29-1.54]; and 1.32 [1.25-1.40], respectively, all P < .0001).

In fathers, type 1 diabetes considered in isolation was associated with a risk of ASD and ADHD in children (AOR, 1.42 [1.10-1.83] and 1.19 [1.08-1.31], respectively), while psoriasis (AOR, 1.18 [1.12-1.24]; P < .0001) is associated with a risk of ADHD in children.

A version of this article first appeared on Medscape.com.

Results of a meta-analysis carried out by a French team indicate that there is a link between a father’s or mother’s autoimmune disease and their children’s risk of developing certain neurodevelopmental disorders (autism spectrum disorder [ASD] and attention-deficit/hyperactivity disorder). This meta-analysis is the first to separately explore the link between a father’s or mother’s autoimmune disease and the onset of neurodevelopmental disorders in their children.

According to its authors, these associations may result from exposure to environmental factors that contribute to autoimmune disorders, such as exposure to pollutants or cigarette smoke, and/or genetic predisposition, including genes relating to cytokines or to the HLA system.

Research is needed to determine the pathophysiologic links between these associations. This study suggests that there could be a shared mechanism between both parents, even though the maternal route seems to constitute an additional excess risk.
 

Why is this important?

Neurodevelopmental disorders are said to occur because of a close interrelationship between a person’s genes and environment. Immune-mediated adverse reactions may play an important role in triggering such disorders, as has been shown in associated epidemiologic studies and in animal studies. Autoimmune and autoinflammatory disorders are effectively characterized by the activation of the immune system, the circulation of autoantibodies, and the secretion of cytokines that are harmful to certain tissues.

Some relevant studies suggest a link between autoimmune disorders in the family or in the mother and the onset of neurodevelopmental disorders in their children. However, none of the studies have distinguished the influence of each of the parents so as to provide data that can be used to assess whether this association is more likely to be direct, and thus established during pregnancy, or rather genetic or environmental.
 

Main findings

Overall, the meta-analysis involved 14 studies that included 845,411 mothers and 601,148 fathers with an autoimmune disease, 4,984,965 control mothers and 4,992,854 control fathers. There were 182,927 children with neurodevelopmental disorders and 14,168,474 with no such diagnosis.

Globally, autoimmune diseases in mothers (adjusted odds ratio, 1.27 [1.03-1.57]; P = .02; I2 = 65%) and in fathers (AOR, 1.18 [1.07-1.30]; P = .01; I2 = 15.5%) are associated with a diagnosis of ASD in children. Similarly, they are associated with an increased risk of ADHD in children (AOR, 1.31 [1.11-1.55]; P = .001; I2 = 93% and AOR, 1.14 [1.10-1.17]; P < .0001; I2 = 0%, respectively, for mothers and fathers).

In mothers, type 1 diabetes (AOR, 1.60 [1.18-2.18]; P = .002; I2 = 0%), psoriasis (AOR, 1.45 [1.14-1.85]; P = .002; I2 = 0%), and rheumatoid arthritis (AOR, 1.38 [1.14-1.68]; P = .001; I2 = 0.8%) were associated with a risk of ASD in children. These three conditions also predisposed children to the risk of ADHD (AOR, 1.36 [1.24-1.52]; 1.41 [1.29-1.54]; and 1.32 [1.25-1.40], respectively, all P < .0001).

In fathers, type 1 diabetes considered in isolation was associated with a risk of ASD and ADHD in children (AOR, 1.42 [1.10-1.83] and 1.19 [1.08-1.31], respectively), while psoriasis (AOR, 1.18 [1.12-1.24]; P < .0001) is associated with a risk of ADHD in children.

A version of this article first appeared on Medscape.com.

LISBON – Two-thirds of antibiotic prescriptions written for Black patients and more than half of antibiotic prescriptions for Hispanic/Latinx patients are inappropriate, according to data from a study of antibiotic prescribing habits in U.S. doctors’ offices, hospital clinics, and emergency departments.

Eric Young, PharmD, PhD, from the University of Texas at Austin, and UT Health, San Antonio, presented his work as a poster at the 32nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) 2022.

“We were really surprised mainly by the racial findings, because Black patients have the highest overall and the highest inappropriate prescribing of antibiotics,” he told this news organization. “There was also a difference seen for age [across all ethnicities].”

Pediatric patients were found to have high overall prescribing but, notably, the lowest inappropriate prescribing among all the patient groups, reported Dr. Young. “This is interesting because oftentimes we think the more antibiotics are prescribed, then surely the greater the inappropriate prescribing would be too, but pediatricians actually have one of the lowest rates of inappropriate antibiotic prescribing. They do a great job.”

The study included more than 7 billion patient visits, 11.3% of which involved an antibiotic prescription.

The rate of antibiotic prescribing was 122 per 1,000 visits in Black patients and 139 per 1,000 visits in Hispanic patients, while in White patients, the rate was 109 per 1,000 visits. The rate was 114 per 1,000 visits in patients younger than 18 years and 170 per 1,000 visits in females.

Dr. Young found that almost 64% of antibiotic prescriptions written for Black patients and 58% for Hispanic patients were inappropriate. For White patients, the rate of inappropriate antibiotic prescribing was 56%. Similarly, 74% of prescriptions dispensed to patients aged 65 years and older and 58% to males were deemed inappropriate.

Kajal Bhakta, PharmD, BCACP, ambulatory care clinical pharmacist, University Health System, UT Health Science Center San Antonio, who was not involved in the study, pointed out that antibiotics are frequently prescribed without confirmation of an infection, owing to the fact that the verification process may delay care, especially in the outpatient setting.

Dr. Bhakta said that overprescribing in the elderly population and in certain ethnic groups was “likely due to socioeconomic and cultural factors. These prescribing methods may lead to unnecessary drug side effects and/or antimicrobial resistance.”

Regarding the patient-doctor consultation process, she pointed out that “older patients may have trouble describing their symptoms, and when those symptoms remain unresolved, providers may be more inclined to prescribe antibiotics to help.”

Sometimes overprescribing can occur because of the logistics involved in getting to the doctor’s office in the outpatient setting. “Sometimes patients struggle with transportation, as two separate trips to the doctor and pharmacy may not be feasible. Additionally, these same patients may have limited access to health care and therefore may use an urgent care facility for their acute infection–like symptoms,” Dr. Bhakta explained.

Dr. Young, who is of Asian descent, first became interested in disparities in health care when he noticed that ethnic minority groups showed greater hesitancy toward COVID-19 vaccination. “I noticed that there weren’t many Asians involved in previous trials and realized at this point that disparities were rampant.”

Dr. Young had been involved in investigating the overall use and the inappropriate use of antibiotics across the whole U.S. population when his interest in health disparities prompted him to study these patterns in specific demographic groups.

“Most previous data are derived from inpatient studies where the physician is giving the antibiotics,” said Dr. Young, who looked specifically at outpatient prescribing.

Dr. Young used prescribing data from the Centers for Disease Control and Prevention’s National Ambulatory Medical Care Survey, which covers more than 5.7 billion adult (aged 18 and older) and 1.3 billion child visits to outpatient practices between 2009 and 2016 across all 50 U.S. states and Washington, D.C.

He gathered patient data on ICD-9-CM and ICD-10 diagnostic codes for infections and for diagnoses that “appeared like infections.” All of the patients who were included had received at least one oral antibiotic. Antibiotic prescribing was defined as visits that included an antibiotic per 1,000 total patient visits.

On the basis of previous research, Dr. Young and his colleagues then determined whether each antibiotic prescription was appropriate, possibly appropriate, or inappropriate. Patient demographics included age (younger than 18 years, 18-64 years, and older than 64 years), sex (male or female), race, and ethnicity (White, Black, more than one race, Hispanic/Latinx, and other). These data were used to evaluate overall and inappropriate use.

“The health care community needs to be really careful with the judicious use of antibiotics,” Dr. Young said. “We have good guidelines on antimicrobial stewardship both in the inpatient and outpatient settings, but sometimes we overlook the disparities and cultural implications held by some patients.”

Typical examples of socioeconomic and cultural factors at play included patients not being able to afford the antibiotics, having limited access to care, or not returning for a follow-up visit for whatever reason.

“Patients of Black and Hispanic descent often don’t have the same degree of established care that many White patients have,” Dr. Young noted.

In the future, Dr. Young wants to conduct research into whether patients are actually taking their prescribed antibiotics, as well as their outcomes. For example, he would like to investigate whether rates of antibiotic resistance or Clostridioides difficile infection are higher among Black patients.

Dr. Young and Dr. Bhakta have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

LISBON – Two-thirds of antibiotic prescriptions written for Black patients and more than half of antibiotic prescriptions for Hispanic/Latinx patients are inappropriate, according to data from a study of antibiotic prescribing habits in U.S. doctors’ offices, hospital clinics, and emergency departments.

Eric Young, PharmD, PhD, from the University of Texas at Austin, and UT Health, San Antonio, presented his work as a poster at the 32nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) 2022.

“We were really surprised mainly by the racial findings, because Black patients have the highest overall and the highest inappropriate prescribing of antibiotics,” he told this news organization. “There was also a difference seen for age [across all ethnicities].”

Pediatric patients were found to have high overall prescribing but, notably, the lowest inappropriate prescribing among all the patient groups, reported Dr. Young. “This is interesting because oftentimes we think the more antibiotics are prescribed, then surely the greater the inappropriate prescribing would be too, but pediatricians actually have one of the lowest rates of inappropriate antibiotic prescribing. They do a great job.”

The study included more than 7 billion patient visits, 11.3% of which involved an antibiotic prescription.

The rate of antibiotic prescribing was 122 per 1,000 visits in Black patients and 139 per 1,000 visits in Hispanic patients, while in White patients, the rate was 109 per 1,000 visits. The rate was 114 per 1,000 visits in patients younger than 18 years and 170 per 1,000 visits in females.

Dr. Young found that almost 64% of antibiotic prescriptions written for Black patients and 58% for Hispanic patients were inappropriate. For White patients, the rate of inappropriate antibiotic prescribing was 56%. Similarly, 74% of prescriptions dispensed to patients aged 65 years and older and 58% to males were deemed inappropriate.

Kajal Bhakta, PharmD, BCACP, ambulatory care clinical pharmacist, University Health System, UT Health Science Center San Antonio, who was not involved in the study, pointed out that antibiotics are frequently prescribed without confirmation of an infection, owing to the fact that the verification process may delay care, especially in the outpatient setting.

Dr. Bhakta said that overprescribing in the elderly population and in certain ethnic groups was “likely due to socioeconomic and cultural factors. These prescribing methods may lead to unnecessary drug side effects and/or antimicrobial resistance.”

Regarding the patient-doctor consultation process, she pointed out that “older patients may have trouble describing their symptoms, and when those symptoms remain unresolved, providers may be more inclined to prescribe antibiotics to help.”

Sometimes overprescribing can occur because of the logistics involved in getting to the doctor’s office in the outpatient setting. “Sometimes patients struggle with transportation, as two separate trips to the doctor and pharmacy may not be feasible. Additionally, these same patients may have limited access to health care and therefore may use an urgent care facility for their acute infection–like symptoms,” Dr. Bhakta explained.

Dr. Young, who is of Asian descent, first became interested in disparities in health care when he noticed that ethnic minority groups showed greater hesitancy toward COVID-19 vaccination. “I noticed that there weren’t many Asians involved in previous trials and realized at this point that disparities were rampant.”

Dr. Young had been involved in investigating the overall use and the inappropriate use of antibiotics across the whole U.S. population when his interest in health disparities prompted him to study these patterns in specific demographic groups.

“Most previous data are derived from inpatient studies where the physician is giving the antibiotics,” said Dr. Young, who looked specifically at outpatient prescribing.

Dr. Young used prescribing data from the Centers for Disease Control and Prevention’s National Ambulatory Medical Care Survey, which covers more than 5.7 billion adult (aged 18 and older) and 1.3 billion child visits to outpatient practices between 2009 and 2016 across all 50 U.S. states and Washington, D.C.

He gathered patient data on ICD-9-CM and ICD-10 diagnostic codes for infections and for diagnoses that “appeared like infections.” All of the patients who were included had received at least one oral antibiotic. Antibiotic prescribing was defined as visits that included an antibiotic per 1,000 total patient visits.

On the basis of previous research, Dr. Young and his colleagues then determined whether each antibiotic prescription was appropriate, possibly appropriate, or inappropriate. Patient demographics included age (younger than 18 years, 18-64 years, and older than 64 years), sex (male or female), race, and ethnicity (White, Black, more than one race, Hispanic/Latinx, and other). These data were used to evaluate overall and inappropriate use.

“The health care community needs to be really careful with the judicious use of antibiotics,” Dr. Young said. “We have good guidelines on antimicrobial stewardship both in the inpatient and outpatient settings, but sometimes we overlook the disparities and cultural implications held by some patients.”

Typical examples of socioeconomic and cultural factors at play included patients not being able to afford the antibiotics, having limited access to care, or not returning for a follow-up visit for whatever reason.

“Patients of Black and Hispanic descent often don’t have the same degree of established care that many White patients have,” Dr. Young noted.

In the future, Dr. Young wants to conduct research into whether patients are actually taking their prescribed antibiotics, as well as their outcomes. For example, he would like to investigate whether rates of antibiotic resistance or Clostridioides difficile infection are higher among Black patients.

Dr. Young and Dr. Bhakta have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

LISBON – Two-thirds of antibiotic prescriptions written for Black patients and more than half of antibiotic prescriptions for Hispanic/Latinx patients are inappropriate, according to data from a study of antibiotic prescribing habits in U.S. doctors’ offices, hospital clinics, and emergency departments.

Eric Young, PharmD, PhD, from the University of Texas at Austin, and UT Health, San Antonio, presented his work as a poster at the 32nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) 2022.

“We were really surprised mainly by the racial findings, because Black patients have the highest overall and the highest inappropriate prescribing of antibiotics,” he told this news organization. “There was also a difference seen for age [across all ethnicities].”

Pediatric patients were found to have high overall prescribing but, notably, the lowest inappropriate prescribing among all the patient groups, reported Dr. Young. “This is interesting because oftentimes we think the more antibiotics are prescribed, then surely the greater the inappropriate prescribing would be too, but pediatricians actually have one of the lowest rates of inappropriate antibiotic prescribing. They do a great job.”

The study included more than 7 billion patient visits, 11.3% of which involved an antibiotic prescription.

The rate of antibiotic prescribing was 122 per 1,000 visits in Black patients and 139 per 1,000 visits in Hispanic patients, while in White patients, the rate was 109 per 1,000 visits. The rate was 114 per 1,000 visits in patients younger than 18 years and 170 per 1,000 visits in females.

Dr. Young found that almost 64% of antibiotic prescriptions written for Black patients and 58% for Hispanic patients were inappropriate. For White patients, the rate of inappropriate antibiotic prescribing was 56%. Similarly, 74% of prescriptions dispensed to patients aged 65 years and older and 58% to males were deemed inappropriate.

Kajal Bhakta, PharmD, BCACP, ambulatory care clinical pharmacist, University Health System, UT Health Science Center San Antonio, who was not involved in the study, pointed out that antibiotics are frequently prescribed without confirmation of an infection, owing to the fact that the verification process may delay care, especially in the outpatient setting.

Dr. Bhakta said that overprescribing in the elderly population and in certain ethnic groups was “likely due to socioeconomic and cultural factors. These prescribing methods may lead to unnecessary drug side effects and/or antimicrobial resistance.”

Regarding the patient-doctor consultation process, she pointed out that “older patients may have trouble describing their symptoms, and when those symptoms remain unresolved, providers may be more inclined to prescribe antibiotics to help.”

Sometimes overprescribing can occur because of the logistics involved in getting to the doctor’s office in the outpatient setting. “Sometimes patients struggle with transportation, as two separate trips to the doctor and pharmacy may not be feasible. Additionally, these same patients may have limited access to health care and therefore may use an urgent care facility for their acute infection–like symptoms,” Dr. Bhakta explained.

Dr. Young, who is of Asian descent, first became interested in disparities in health care when he noticed that ethnic minority groups showed greater hesitancy toward COVID-19 vaccination. “I noticed that there weren’t many Asians involved in previous trials and realized at this point that disparities were rampant.”

Dr. Young had been involved in investigating the overall use and the inappropriate use of antibiotics across the whole U.S. population when his interest in health disparities prompted him to study these patterns in specific demographic groups.

“Most previous data are derived from inpatient studies where the physician is giving the antibiotics,” said Dr. Young, who looked specifically at outpatient prescribing.

Dr. Young used prescribing data from the Centers for Disease Control and Prevention’s National Ambulatory Medical Care Survey, which covers more than 5.7 billion adult (aged 18 and older) and 1.3 billion child visits to outpatient practices between 2009 and 2016 across all 50 U.S. states and Washington, D.C.

He gathered patient data on ICD-9-CM and ICD-10 diagnostic codes for infections and for diagnoses that “appeared like infections.” All of the patients who were included had received at least one oral antibiotic. Antibiotic prescribing was defined as visits that included an antibiotic per 1,000 total patient visits.

On the basis of previous research, Dr. Young and his colleagues then determined whether each antibiotic prescription was appropriate, possibly appropriate, or inappropriate. Patient demographics included age (younger than 18 years, 18-64 years, and older than 64 years), sex (male or female), race, and ethnicity (White, Black, more than one race, Hispanic/Latinx, and other). These data were used to evaluate overall and inappropriate use.

“The health care community needs to be really careful with the judicious use of antibiotics,” Dr. Young said. “We have good guidelines on antimicrobial stewardship both in the inpatient and outpatient settings, but sometimes we overlook the disparities and cultural implications held by some patients.”

Typical examples of socioeconomic and cultural factors at play included patients not being able to afford the antibiotics, having limited access to care, or not returning for a follow-up visit for whatever reason.

“Patients of Black and Hispanic descent often don’t have the same degree of established care that many White patients have,” Dr. Young noted.

In the future, Dr. Young wants to conduct research into whether patients are actually taking their prescribed antibiotics, as well as their outcomes. For example, he would like to investigate whether rates of antibiotic resistance or Clostridioides difficile infection are higher among Black patients.

Dr. Young and Dr. Bhakta have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

At the conclusion of this activity, the participant will be able to:
• Appreciate the scope of the problem of Candida infection in terms of cost, lost productivity, and medical visits
• Learn current diagnostic and treatment patterns for vulvovaginal candidiasis
• Appreciate the attributes of the new antifungal class (triterpenoids) for vulvovaginal candidiasis
• Analyze clinical trial data with the non-azole approach to vulvovaginal candidiasis

Click here to read this supplement

To access post-test and evaluation, visit www.worldclasscme.com/online-courses/new-approach-old-problem-no-longer-just-azoles-candida

World Class CME designates this journal-based CME activity for a maximum of 1.0 AMA PRA Category1 Credit™.

At the conclusion of this activity, the participant will be able to:
• Appreciate the scope of the problem of Candida infection in terms of cost, lost productivity, and medical visits
• Learn current diagnostic and treatment patterns for vulvovaginal candidiasis
• Appreciate the attributes of the new antifungal class (triterpenoids) for vulvovaginal candidiasis
• Analyze clinical trial data with the non-azole approach to vulvovaginal candidiasis

Click here to read this supplement

To access post-test and evaluation, visit www.worldclasscme.com/online-courses/new-approach-old-problem-no-longer-just-azoles-candida

World Class CME designates this journal-based CME activity for a maximum of 1.0 AMA PRA Category1 Credit™.

At the conclusion of this activity, the participant will be able to:
• Appreciate the scope of the problem of Candida infection in terms of cost, lost productivity, and medical visits
• Learn current diagnostic and treatment patterns for vulvovaginal candidiasis
• Appreciate the attributes of the new antifungal class (triterpenoids) for vulvovaginal candidiasis
• Analyze clinical trial data with the non-azole approach to vulvovaginal candidiasis

Click here to read this supplement

To access post-test and evaluation, visit www.worldclasscme.com/online-courses/new-approach-old-problem-no-longer-just-azoles-candida

World Class CME designates this journal-based CME activity for a maximum of 1.0 AMA PRA Category1 Credit™.

A combination of ulipristal acetate (UA) and a cyclo-oxygenase-2 (COX-2) inhibitor holds promise as a pericoital, “on- demand” female oral contraceptive, taken only when needed, according to an exploratory study published in BMJ Sexual & Reproductive Health.

The prospective, open-label, pilot study showed that UA and meloxicam successfully disrupted ovulation at “the peak of luteal surge, when conception risk is highest,” reported lead author Erica P Cahill, MD, of Stanford (Calif.) University, and colleagues.

“There are many people who report being interested in preventing pregnancy who are not using contraception,” Dr. Cahill said in an interview. The ideal is to be able to take a medication to prevent ovulation and know that you wouldn’t ovulate or be able to become pregnant for the next 3-5 days. These would be pericoital contraceptive pills that one could take prior to or immediately after intercourse that would expand the contraceptive options available and meet some of this need, she said.

Dr. Cahill said currently approved emergency contraceptives containing ulipristal acetate or levonorgestrel “work by inhibiting ovulation at the level of the luteal surge, the pituitary signal that starts the ovulation cascade. Because of this mechanism, they are only effective when taken prior to that signal. If they are taken near or after ovulation has occurred, they are not effective.” She said combining meloxicam with UA could address this because meloxicam “has been shown to prevent some of the later steps of ovulation just prior to the egg being released.”

The study included nine healthy women, with a mean age of 31.4 years, and a mean body mass index of 24.5 ± 3.9 kg/m². All subjects had no exposure to hormonal medication, pregnancy, or lactation in the prior 3 months.

Each participant was followed for two cycles: The first without treatment, to establish normal ovulatory function; and the second during treatment with a one-time dose of UA 30 mg and meloxicam 30 mg during the “fertile window.” This window was defined as when the lead ovarian follicle had a mean diameter of 18 mm, and was determined via thrice-weekly ultrasounds, as well as luteinizing hormone (LH) measurements.

The primary outcome of the study was ovulation disruption, defined as unruptured dominant follicle for 5 days, a blunted LH peak, defined as <15 IU/L, and a nonovulatory luteal phase progesterone level, defined as <3 ng/mL.

Ovulation disruption was achieved in six subjects (67.7%), with eight subjects (88.9%) meeting some criteria.

“When we compare ovulation disruption rates in our study with the previous studies on which our protocol is based, the combination of UA and meloxicam disrupted ovulation at each phase of the fertile window more than any other medication previously studied,” the researchers wrote. “This medication combination is an important candidate to evaluate as oral pericoital contraception.”

When comparing subjects’ baseline cycles with their treatment cycles, the latter were approximately 3 days longer, although there was no difference in endometrial stripe thickness or irregular bleeding.

“Cycle length changes are an important parameter as people interested in oral, on-demand contraception may also be using fertility awareness methods which can be affected by cycle length changes.”

The authors noted that measures of full efficacy and side effects were beyond the scope of the study and would require repeat dosing. Similarly, liver enzymes were not measured, because there was only one dose of study medication, but “given the potential impact of repeat UA on liver enzymes, this measurement is critical for future studies.”

Asked to comment on the study, Eve Espey, MD, said that although it was limited in size and the use of an “intermediate outcome” of ovulation disruption, “the combination does show some promise as a focus of future research.” However, Dr. Espey, distinguished professor and chair in the department of obstetrics and gynecology at the University of New Mexico, Albuquerque, said it is too early to determine the significance of the findings. “But it does point the way to further research,” she noted. “Compared with existing emergency contraception, this study shows that the UA-meloxicam combination disrupts ovulation over a broader mid-cycle time period – [an] extended duration of action [that] could theoretically translate into increased effectiveness as a contraceptive.”

The study was supported by the Society for Family Planning Research Fund. None of the authors, or Dr. Espey, declared competing interests.

A combination of ulipristal acetate (UA) and a cyclo-oxygenase-2 (COX-2) inhibitor holds promise as a pericoital, “on- demand” female oral contraceptive, taken only when needed, according to an exploratory study published in BMJ Sexual & Reproductive Health.

The prospective, open-label, pilot study showed that UA and meloxicam successfully disrupted ovulation at “the peak of luteal surge, when conception risk is highest,” reported lead author Erica P Cahill, MD, of Stanford (Calif.) University, and colleagues.

“There are many people who report being interested in preventing pregnancy who are not using contraception,” Dr. Cahill said in an interview. The ideal is to be able to take a medication to prevent ovulation and know that you wouldn’t ovulate or be able to become pregnant for the next 3-5 days. These would be pericoital contraceptive pills that one could take prior to or immediately after intercourse that would expand the contraceptive options available and meet some of this need, she said.

Dr. Cahill said currently approved emergency contraceptives containing ulipristal acetate or levonorgestrel “work by inhibiting ovulation at the level of the luteal surge, the pituitary signal that starts the ovulation cascade. Because of this mechanism, they are only effective when taken prior to that signal. If they are taken near or after ovulation has occurred, they are not effective.” She said combining meloxicam with UA could address this because meloxicam “has been shown to prevent some of the later steps of ovulation just prior to the egg being released.”

The study included nine healthy women, with a mean age of 31.4 years, and a mean body mass index of 24.5 ± 3.9 kg/m². All subjects had no exposure to hormonal medication, pregnancy, or lactation in the prior 3 months.

Each participant was followed for two cycles: The first without treatment, to establish normal ovulatory function; and the second during treatment with a one-time dose of UA 30 mg and meloxicam 30 mg during the “fertile window.” This window was defined as when the lead ovarian follicle had a mean diameter of 18 mm, and was determined via thrice-weekly ultrasounds, as well as luteinizing hormone (LH) measurements.

The primary outcome of the study was ovulation disruption, defined as unruptured dominant follicle for 5 days, a blunted LH peak, defined as <15 IU/L, and a nonovulatory luteal phase progesterone level, defined as <3 ng/mL.

Ovulation disruption was achieved in six subjects (67.7%), with eight subjects (88.9%) meeting some criteria.

“When we compare ovulation disruption rates in our study with the previous studies on which our protocol is based, the combination of UA and meloxicam disrupted ovulation at each phase of the fertile window more than any other medication previously studied,” the researchers wrote. “This medication combination is an important candidate to evaluate as oral pericoital contraception.”

When comparing subjects’ baseline cycles with their treatment cycles, the latter were approximately 3 days longer, although there was no difference in endometrial stripe thickness or irregular bleeding.

“Cycle length changes are an important parameter as people interested in oral, on-demand contraception may also be using fertility awareness methods which can be affected by cycle length changes.”

The authors noted that measures of full efficacy and side effects were beyond the scope of the study and would require repeat dosing. Similarly, liver enzymes were not measured, because there was only one dose of study medication, but “given the potential impact of repeat UA on liver enzymes, this measurement is critical for future studies.”

Asked to comment on the study, Eve Espey, MD, said that although it was limited in size and the use of an “intermediate outcome” of ovulation disruption, “the combination does show some promise as a focus of future research.” However, Dr. Espey, distinguished professor and chair in the department of obstetrics and gynecology at the University of New Mexico, Albuquerque, said it is too early to determine the significance of the findings. “But it does point the way to further research,” she noted. “Compared with existing emergency contraception, this study shows that the UA-meloxicam combination disrupts ovulation over a broader mid-cycle time period – [an] extended duration of action [that] could theoretically translate into increased effectiveness as a contraceptive.”

The study was supported by the Society for Family Planning Research Fund. None of the authors, or Dr. Espey, declared competing interests.

A combination of ulipristal acetate (UA) and a cyclo-oxygenase-2 (COX-2) inhibitor holds promise as a pericoital, “on- demand” female oral contraceptive, taken only when needed, according to an exploratory study published in BMJ Sexual & Reproductive Health.

The prospective, open-label, pilot study showed that UA and meloxicam successfully disrupted ovulation at “the peak of luteal surge, when conception risk is highest,” reported lead author Erica P Cahill, MD, of Stanford (Calif.) University, and colleagues.

“There are many people who report being interested in preventing pregnancy who are not using contraception,” Dr. Cahill said in an interview. The ideal is to be able to take a medication to prevent ovulation and know that you wouldn’t ovulate or be able to become pregnant for the next 3-5 days. These would be pericoital contraceptive pills that one could take prior to or immediately after intercourse that would expand the contraceptive options available and meet some of this need, she said.

Dr. Cahill said currently approved emergency contraceptives containing ulipristal acetate or levonorgestrel “work by inhibiting ovulation at the level of the luteal surge, the pituitary signal that starts the ovulation cascade. Because of this mechanism, they are only effective when taken prior to that signal. If they are taken near or after ovulation has occurred, they are not effective.” She said combining meloxicam with UA could address this because meloxicam “has been shown to prevent some of the later steps of ovulation just prior to the egg being released.”

The study included nine healthy women, with a mean age of 31.4 years, and a mean body mass index of 24.5 ± 3.9 kg/m². All subjects had no exposure to hormonal medication, pregnancy, or lactation in the prior 3 months.

Each participant was followed for two cycles: The first without treatment, to establish normal ovulatory function; and the second during treatment with a one-time dose of UA 30 mg and meloxicam 30 mg during the “fertile window.” This window was defined as when the lead ovarian follicle had a mean diameter of 18 mm, and was determined via thrice-weekly ultrasounds, as well as luteinizing hormone (LH) measurements.

The primary outcome of the study was ovulation disruption, defined as unruptured dominant follicle for 5 days, a blunted LH peak, defined as <15 IU/L, and a nonovulatory luteal phase progesterone level, defined as <3 ng/mL.

Ovulation disruption was achieved in six subjects (67.7%), with eight subjects (88.9%) meeting some criteria.

“When we compare ovulation disruption rates in our study with the previous studies on which our protocol is based, the combination of UA and meloxicam disrupted ovulation at each phase of the fertile window more than any other medication previously studied,” the researchers wrote. “This medication combination is an important candidate to evaluate as oral pericoital contraception.”

When comparing subjects’ baseline cycles with their treatment cycles, the latter were approximately 3 days longer, although there was no difference in endometrial stripe thickness or irregular bleeding.

“Cycle length changes are an important parameter as people interested in oral, on-demand contraception may also be using fertility awareness methods which can be affected by cycle length changes.”

The authors noted that measures of full efficacy and side effects were beyond the scope of the study and would require repeat dosing. Similarly, liver enzymes were not measured, because there was only one dose of study medication, but “given the potential impact of repeat UA on liver enzymes, this measurement is critical for future studies.”

Asked to comment on the study, Eve Espey, MD, said that although it was limited in size and the use of an “intermediate outcome” of ovulation disruption, “the combination does show some promise as a focus of future research.” However, Dr. Espey, distinguished professor and chair in the department of obstetrics and gynecology at the University of New Mexico, Albuquerque, said it is too early to determine the significance of the findings. “But it does point the way to further research,” she noted. “Compared with existing emergency contraception, this study shows that the UA-meloxicam combination disrupts ovulation over a broader mid-cycle time period – [an] extended duration of action [that] could theoretically translate into increased effectiveness as a contraceptive.”

The study was supported by the Society for Family Planning Research Fund. None of the authors, or Dr. Espey, declared competing interests.