Lucas Franki is an associate editor for MDedge News, and has been with the company since 2014. He has a BA in English from Penn State University and is an Eagle Scout.

Texting a stroke, game-show grants, and, um, The Beast

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Autocorrect, or worse?

Is it just fat thumbs, or something more serious? Incoherent text messages could be the first sign of a stroke for adults, as displayed in two case reports presented at the annual meeting of the American Academy of Neurology.

Vladyslav Bobuskyi/iStock/Getty Images Plus
Researchers have dubbed this problem “dystextia,” a new stroke warning sign for our digital age. If someone you know is making more typos than usual in a text, give them a friendly call. It could be that they are experiencing a stroke … or it could be that they just recently updated their phone and don’t know how to turn off that newfangled predictive text.

It makes sense that stroke can cause dystextia: Typing on a phone involves some fine motor, language, and vision skills. Stroke can affect all these functions, leading to bizarre typos or angry political rants on Facebook.

Just kidding; those are equally as concerning but require a whole different diagnosis.

‘Research Funds’ for $11,000, Alex

In the universal struggle for research funding, many a scientist has resorted to desperate measures to keep the lab assistants paid, the JAX Mice fed, and the frontiers of medical science expanding ever outward.

RichLegg/E+
Now, one savvy Argentinian oncology researcher has found a novel funding source for her fellow grant-impaired investigators: game shows.

Marina Simian is a biologist for Argentina’s National Scientific and Technical Research Council. She runs a research lab focused on oncology treatments for breast cancer. Faced with a national economic crisis and cuts to research funding, Simian says government funding has nearly dried up. Where did she turn instead?

Enter the local version of the TV game show “Who Wants to be a Millionaire?” Simian went on the show as a contestant, explaining that she needed money to support her cancer research. And when the camera cut away to commercials, Simian walked away with 500,000 pesos ($11,000) in winnings. Which she used to buy more lab supplies.

Admittedly, the “Slumdog Millionaire” approach may not save every cash-strapped scientist’s pet project, but it does give us an idea for game show super champ James Holzhauer’s career when he finally wears out his “Jeopardy!” buzzer: medical research funding consultant.

FDA tames THE BEAST

The LOTME staff had a meeting the other day with our editor (we think he might be the love child of Lois Lane and Ron Burgundy), who said that lately we’ve been “too juvenile” and “not medical enough” and told us to get our “dirty little minds out of the gutter.”

Stas_V/iStock/Getty Images Plus

After we stopped crying, he offered up this item from the Food and Drug Administration:

“STIFF BOY LLC. Issues Voluntary Nationwide Recall of THE BEAST Capsules Due to Presence of Undeclared Sildenafil” (no, we did not add the all-caps).

Okay, here goes.

THE BEAST was marketed as a dietary supplement for “male enhancement” (add nonjuvenile but hilarious remark about tumescence), which would not be regulated by the FDA. The presence of Viagra’s active ingredient in the capsules, however, “renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall,” the FDA said (insert comment about seemingly serious but totally fictitious side effects).

Although the sildenafil in THE BEAST may interact with nitrates found in some prescription drugs, STIFF BOY said that it had not received any reports of adverse events before the recall (imagine a guy working on the engine of his pickup truck).

Seek immediate medical attention if your laughter lasts for more than 4 hours after reading this.

 

 

Time flies when you’re having ‘fun’

Match Day is one of the most exciting times in any young, prospective doctor’s life. Finally, the specialty of your dreams is yours. You know the training will be stressful and the hours will be long, but how bad could it be?

wildpixel/iStock/Getty Images Plus

It’s not like it’ll take years off your life, right?

Well, according to new research published in Biological Psychiatry, that’s almost exactly what medical residency will do to you.

The researchers took a group of medical students at the University of Michigan, Ann Arbor, entering their first year of residency and measured their telomere length both before and after their internship year, comparing it with a group of first-year undergraduates. Rapidly shrinking telomere length is a well-accepted sign of aging, and interns had their telomeres shrink at a rate six times faster than their nonmedical peers, who were apparently too busy doing upside-down kegstands to notice how stressful college can be.

Oh, don’t worry, there was most definitely an association between hours worked and increased telomere shrinkage. Those who had to work more than 80 hours a week aged most of all.

So, if you emerge from a particularly difficult internship with the sudden desire to yell at those darn kids for being on your lawn, we completely understand.






 

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Autocorrect, or worse?

Is it just fat thumbs, or something more serious? Incoherent text messages could be the first sign of a stroke for adults, as displayed in two case reports presented at the annual meeting of the American Academy of Neurology.

Vladyslav Bobuskyi/iStock/Getty Images Plus
Researchers have dubbed this problem “dystextia,” a new stroke warning sign for our digital age. If someone you know is making more typos than usual in a text, give them a friendly call. It could be that they are experiencing a stroke … or it could be that they just recently updated their phone and don’t know how to turn off that newfangled predictive text.

It makes sense that stroke can cause dystextia: Typing on a phone involves some fine motor, language, and vision skills. Stroke can affect all these functions, leading to bizarre typos or angry political rants on Facebook.

Just kidding; those are equally as concerning but require a whole different diagnosis.

‘Research Funds’ for $11,000, Alex

In the universal struggle for research funding, many a scientist has resorted to desperate measures to keep the lab assistants paid, the JAX Mice fed, and the frontiers of medical science expanding ever outward.

RichLegg/E+
Now, one savvy Argentinian oncology researcher has found a novel funding source for her fellow grant-impaired investigators: game shows.

Marina Simian is a biologist for Argentina’s National Scientific and Technical Research Council. She runs a research lab focused on oncology treatments for breast cancer. Faced with a national economic crisis and cuts to research funding, Simian says government funding has nearly dried up. Where did she turn instead?

Enter the local version of the TV game show “Who Wants to be a Millionaire?” Simian went on the show as a contestant, explaining that she needed money to support her cancer research. And when the camera cut away to commercials, Simian walked away with 500,000 pesos ($11,000) in winnings. Which she used to buy more lab supplies.

Admittedly, the “Slumdog Millionaire” approach may not save every cash-strapped scientist’s pet project, but it does give us an idea for game show super champ James Holzhauer’s career when he finally wears out his “Jeopardy!” buzzer: medical research funding consultant.

FDA tames THE BEAST

The LOTME staff had a meeting the other day with our editor (we think he might be the love child of Lois Lane and Ron Burgundy), who said that lately we’ve been “too juvenile” and “not medical enough” and told us to get our “dirty little minds out of the gutter.”

Stas_V/iStock/Getty Images Plus

After we stopped crying, he offered up this item from the Food and Drug Administration:

“STIFF BOY LLC. Issues Voluntary Nationwide Recall of THE BEAST Capsules Due to Presence of Undeclared Sildenafil” (no, we did not add the all-caps).

Okay, here goes.

THE BEAST was marketed as a dietary supplement for “male enhancement” (add nonjuvenile but hilarious remark about tumescence), which would not be regulated by the FDA. The presence of Viagra’s active ingredient in the capsules, however, “renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall,” the FDA said (insert comment about seemingly serious but totally fictitious side effects).

Although the sildenafil in THE BEAST may interact with nitrates found in some prescription drugs, STIFF BOY said that it had not received any reports of adverse events before the recall (imagine a guy working on the engine of his pickup truck).

Seek immediate medical attention if your laughter lasts for more than 4 hours after reading this.

 

 

Time flies when you’re having ‘fun’

Match Day is one of the most exciting times in any young, prospective doctor’s life. Finally, the specialty of your dreams is yours. You know the training will be stressful and the hours will be long, but how bad could it be?

wildpixel/iStock/Getty Images Plus

It’s not like it’ll take years off your life, right?

Well, according to new research published in Biological Psychiatry, that’s almost exactly what medical residency will do to you.

The researchers took a group of medical students at the University of Michigan, Ann Arbor, entering their first year of residency and measured their telomere length both before and after their internship year, comparing it with a group of first-year undergraduates. Rapidly shrinking telomere length is a well-accepted sign of aging, and interns had their telomeres shrink at a rate six times faster than their nonmedical peers, who were apparently too busy doing upside-down kegstands to notice how stressful college can be.

Oh, don’t worry, there was most definitely an association between hours worked and increased telomere shrinkage. Those who had to work more than 80 hours a week aged most of all.

So, if you emerge from a particularly difficult internship with the sudden desire to yell at those darn kids for being on your lawn, we completely understand.






 

 

Autocorrect, or worse?

Is it just fat thumbs, or something more serious? Incoherent text messages could be the first sign of a stroke for adults, as displayed in two case reports presented at the annual meeting of the American Academy of Neurology.

Vladyslav Bobuskyi/iStock/Getty Images Plus
Researchers have dubbed this problem “dystextia,” a new stroke warning sign for our digital age. If someone you know is making more typos than usual in a text, give them a friendly call. It could be that they are experiencing a stroke … or it could be that they just recently updated their phone and don’t know how to turn off that newfangled predictive text.

It makes sense that stroke can cause dystextia: Typing on a phone involves some fine motor, language, and vision skills. Stroke can affect all these functions, leading to bizarre typos or angry political rants on Facebook.

Just kidding; those are equally as concerning but require a whole different diagnosis.

‘Research Funds’ for $11,000, Alex

In the universal struggle for research funding, many a scientist has resorted to desperate measures to keep the lab assistants paid, the JAX Mice fed, and the frontiers of medical science expanding ever outward.

RichLegg/E+
Now, one savvy Argentinian oncology researcher has found a novel funding source for her fellow grant-impaired investigators: game shows.

Marina Simian is a biologist for Argentina’s National Scientific and Technical Research Council. She runs a research lab focused on oncology treatments for breast cancer. Faced with a national economic crisis and cuts to research funding, Simian says government funding has nearly dried up. Where did she turn instead?

Enter the local version of the TV game show “Who Wants to be a Millionaire?” Simian went on the show as a contestant, explaining that she needed money to support her cancer research. And when the camera cut away to commercials, Simian walked away with 500,000 pesos ($11,000) in winnings. Which she used to buy more lab supplies.

Admittedly, the “Slumdog Millionaire” approach may not save every cash-strapped scientist’s pet project, but it does give us an idea for game show super champ James Holzhauer’s career when he finally wears out his “Jeopardy!” buzzer: medical research funding consultant.

FDA tames THE BEAST

The LOTME staff had a meeting the other day with our editor (we think he might be the love child of Lois Lane and Ron Burgundy), who said that lately we’ve been “too juvenile” and “not medical enough” and told us to get our “dirty little minds out of the gutter.”

Stas_V/iStock/Getty Images Plus

After we stopped crying, he offered up this item from the Food and Drug Administration:

“STIFF BOY LLC. Issues Voluntary Nationwide Recall of THE BEAST Capsules Due to Presence of Undeclared Sildenafil” (no, we did not add the all-caps).

Okay, here goes.

THE BEAST was marketed as a dietary supplement for “male enhancement” (add nonjuvenile but hilarious remark about tumescence), which would not be regulated by the FDA. The presence of Viagra’s active ingredient in the capsules, however, “renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall,” the FDA said (insert comment about seemingly serious but totally fictitious side effects).

Although the sildenafil in THE BEAST may interact with nitrates found in some prescription drugs, STIFF BOY said that it had not received any reports of adverse events before the recall (imagine a guy working on the engine of his pickup truck).

Seek immediate medical attention if your laughter lasts for more than 4 hours after reading this.

 

 

Time flies when you’re having ‘fun’

Match Day is one of the most exciting times in any young, prospective doctor’s life. Finally, the specialty of your dreams is yours. You know the training will be stressful and the hours will be long, but how bad could it be?

wildpixel/iStock/Getty Images Plus

It’s not like it’ll take years off your life, right?

Well, according to new research published in Biological Psychiatry, that’s almost exactly what medical residency will do to you.

The researchers took a group of medical students at the University of Michigan, Ann Arbor, entering their first year of residency and measured their telomere length both before and after their internship year, comparing it with a group of first-year undergraduates. Rapidly shrinking telomere length is a well-accepted sign of aging, and interns had their telomeres shrink at a rate six times faster than their nonmedical peers, who were apparently too busy doing upside-down kegstands to notice how stressful college can be.

Oh, don’t worry, there was most definitely an association between hours worked and increased telomere shrinkage. Those who had to work more than 80 hours a week aged most of all.

So, if you emerge from a particularly difficult internship with the sudden desire to yell at those darn kids for being on your lawn, we completely understand.






 

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ICYMI: Dabigatran no better than aspirin for recurrent stroke prevention

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Dabigatran was slightly but not significantly superior to aspirin at the prevention of recurring stroke in patients with a recent history of embolic stroke of undetermined source over a median follow-up of 19 months (6.6% rate of recurrent stroke for dabigatran vs. 7.7% for aspirin; hazard ratio, 0.85; 95% confidence interval, 0.69-1.03; P = 0.10), according to RE-SPECT ESUS, a multicenter, randomized, double-blind trial published in the New England Journal of Medicine (2019 May 15. doi: 10.1056/NEJMoa1813959).

We first reported on the results of this trial when they were presented at the World Stroke Congress by lead investigator Hans-Christoph Diener, MD. Find our coverage at the link below.

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Dabigatran was slightly but not significantly superior to aspirin at the prevention of recurring stroke in patients with a recent history of embolic stroke of undetermined source over a median follow-up of 19 months (6.6% rate of recurrent stroke for dabigatran vs. 7.7% for aspirin; hazard ratio, 0.85; 95% confidence interval, 0.69-1.03; P = 0.10), according to RE-SPECT ESUS, a multicenter, randomized, double-blind trial published in the New England Journal of Medicine (2019 May 15. doi: 10.1056/NEJMoa1813959).

We first reported on the results of this trial when they were presented at the World Stroke Congress by lead investigator Hans-Christoph Diener, MD. Find our coverage at the link below.

 

Dabigatran was slightly but not significantly superior to aspirin at the prevention of recurring stroke in patients with a recent history of embolic stroke of undetermined source over a median follow-up of 19 months (6.6% rate of recurrent stroke for dabigatran vs. 7.7% for aspirin; hazard ratio, 0.85; 95% confidence interval, 0.69-1.03; P = 0.10), according to RE-SPECT ESUS, a multicenter, randomized, double-blind trial published in the New England Journal of Medicine (2019 May 15. doi: 10.1056/NEJMoa1813959).

We first reported on the results of this trial when they were presented at the World Stroke Congress by lead investigator Hans-Christoph Diener, MD. Find our coverage at the link below.

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ICYMI: Alpelisib/fulvestrant combo boosts PFS in advanced breast cancer

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Patients with PIK3CA-mutated, hormone receptor–positive, HER2-negative advanced breast cancer who had previously undergone endocrine therapy experienced longer progression-free survival when receiving alpelisib and fulvestrant, compared with placebo and fulvestrant (11.0 vs. 5.7 months; hazard ratio, 0.65; 95% confidence interval, 0.50-0.85; P less than .001), according to a randomized, phase 3 trial published in the New England Journal of Medicine (2019 May 15. doi: 10.1056/NEJMoa1813904).

We first reported on the results of this trial when they were presented at the European Society for Medical Oncology Congress. Find our coverage at the link below.



 

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Patients with PIK3CA-mutated, hormone receptor–positive, HER2-negative advanced breast cancer who had previously undergone endocrine therapy experienced longer progression-free survival when receiving alpelisib and fulvestrant, compared with placebo and fulvestrant (11.0 vs. 5.7 months; hazard ratio, 0.65; 95% confidence interval, 0.50-0.85; P less than .001), according to a randomized, phase 3 trial published in the New England Journal of Medicine (2019 May 15. doi: 10.1056/NEJMoa1813904).

We first reported on the results of this trial when they were presented at the European Society for Medical Oncology Congress. Find our coverage at the link below.



 

Patients with PIK3CA-mutated, hormone receptor–positive, HER2-negative advanced breast cancer who had previously undergone endocrine therapy experienced longer progression-free survival when receiving alpelisib and fulvestrant, compared with placebo and fulvestrant (11.0 vs. 5.7 months; hazard ratio, 0.65; 95% confidence interval, 0.50-0.85; P less than .001), according to a randomized, phase 3 trial published in the New England Journal of Medicine (2019 May 15. doi: 10.1056/NEJMoa1813904).

We first reported on the results of this trial when they were presented at the European Society for Medical Oncology Congress. Find our coverage at the link below.



 

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BTK inhibitor reduces MS enhancing lesions

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Patients with relapsing multiple sclerosis who received 75 mg of the Bruton’s tyrosine kinase inhibitor evobrutinib once daily had significantly fewer enhancing lesions from 12 to 24 weeks than did those who received placebo. However, there was no difference between the 25-mg once daily, 75-mg once daily, 75-mg twice daily, and placebo-treated groups in Expanded Disability Status Scale scores, according to a double-blind, randomized, phase 2 trial published in the New England Journal of Medicine (2019 May 10. doi: 10.1056/NEJMoa1901981).

We first reported on the results of this trial when they were presented at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis. Find our coverage at the link below.

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Patients with relapsing multiple sclerosis who received 75 mg of the Bruton’s tyrosine kinase inhibitor evobrutinib once daily had significantly fewer enhancing lesions from 12 to 24 weeks than did those who received placebo. However, there was no difference between the 25-mg once daily, 75-mg once daily, 75-mg twice daily, and placebo-treated groups in Expanded Disability Status Scale scores, according to a double-blind, randomized, phase 2 trial published in the New England Journal of Medicine (2019 May 10. doi: 10.1056/NEJMoa1901981).

We first reported on the results of this trial when they were presented at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis. Find our coverage at the link below.

 

Patients with relapsing multiple sclerosis who received 75 mg of the Bruton’s tyrosine kinase inhibitor evobrutinib once daily had significantly fewer enhancing lesions from 12 to 24 weeks than did those who received placebo. However, there was no difference between the 25-mg once daily, 75-mg once daily, 75-mg twice daily, and placebo-treated groups in Expanded Disability Status Scale scores, according to a double-blind, randomized, phase 2 trial published in the New England Journal of Medicine (2019 May 10. doi: 10.1056/NEJMoa1901981).

We first reported on the results of this trial when they were presented at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis. Find our coverage at the link below.

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QI boosts adherence to protocol-based care for elevated blood lead levels

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Development and use of a specific protocol significantly increased the likelihood of children with elevated blood lead levels receiving standardized care, according to current guidelines, reported Courtney M. Brown, MD, and associates at Cincinnati Children’s Hospital and the University of Cincinnati.

The study protocol, undertaken at Cincinnati Children’s Hospital Medical Center’s pediatric primary care center, consisted of ordering multivitamins with iron and follow-up lead testing, educating families about identifying and reducing sources of lead exposure, and referring to a specialty environmental health clinic when indicated. Quality improvement and a real-time decision support program called Epic SmartPhrase was used to increase provider adherence. Results from patients aged 9-27 months who were seen at the hospital from February 2016 to June 2018 were included, according to the researchers. Their findings were published in Pediatrics.

Over the study period, 634 elevated blood lead levels (BLLs) were recorded. Between February 2016 – when the protocol was distributed – and May 2017 – when Epic SmartPhrase was introduced – a mean of 5% of cases received protocol-based care. After introduction of Epic Smartphase, the rate of adherence to protocol increased to 90%, which was maintained for the rest of the study.

“A reliable system for responding to BLLs is critical for optimizing outcomes for individuals, as well as activating public health systems to reduce environmental lead sources. Using tools within the EHR, we increased provider adherence with published guidelines. Our Epic SmartPhrase could be easily reproduced by other practices using EHRs. Similar strategies could be applied for standardizing the response to other laboratory tests,” the investigators wrote. “This type of intervention could ensure that screenings of all kinds trigger meaningful interventions.”

The study was supported by the Cincinnati Children’s Hospital Medical Center through the All Children Thrive community health initiative; the study authors had no relevant financial disclosures.

SOURCE: Brown CM et al. Pediatrics. 2019 May 9. doi: 10.1542/peds.2018-3085.

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Development and use of a specific protocol significantly increased the likelihood of children with elevated blood lead levels receiving standardized care, according to current guidelines, reported Courtney M. Brown, MD, and associates at Cincinnati Children’s Hospital and the University of Cincinnati.

The study protocol, undertaken at Cincinnati Children’s Hospital Medical Center’s pediatric primary care center, consisted of ordering multivitamins with iron and follow-up lead testing, educating families about identifying and reducing sources of lead exposure, and referring to a specialty environmental health clinic when indicated. Quality improvement and a real-time decision support program called Epic SmartPhrase was used to increase provider adherence. Results from patients aged 9-27 months who were seen at the hospital from February 2016 to June 2018 were included, according to the researchers. Their findings were published in Pediatrics.

Over the study period, 634 elevated blood lead levels (BLLs) were recorded. Between February 2016 – when the protocol was distributed – and May 2017 – when Epic SmartPhrase was introduced – a mean of 5% of cases received protocol-based care. After introduction of Epic Smartphase, the rate of adherence to protocol increased to 90%, which was maintained for the rest of the study.

“A reliable system for responding to BLLs is critical for optimizing outcomes for individuals, as well as activating public health systems to reduce environmental lead sources. Using tools within the EHR, we increased provider adherence with published guidelines. Our Epic SmartPhrase could be easily reproduced by other practices using EHRs. Similar strategies could be applied for standardizing the response to other laboratory tests,” the investigators wrote. “This type of intervention could ensure that screenings of all kinds trigger meaningful interventions.”

The study was supported by the Cincinnati Children’s Hospital Medical Center through the All Children Thrive community health initiative; the study authors had no relevant financial disclosures.

SOURCE: Brown CM et al. Pediatrics. 2019 May 9. doi: 10.1542/peds.2018-3085.

 

Development and use of a specific protocol significantly increased the likelihood of children with elevated blood lead levels receiving standardized care, according to current guidelines, reported Courtney M. Brown, MD, and associates at Cincinnati Children’s Hospital and the University of Cincinnati.

The study protocol, undertaken at Cincinnati Children’s Hospital Medical Center’s pediatric primary care center, consisted of ordering multivitamins with iron and follow-up lead testing, educating families about identifying and reducing sources of lead exposure, and referring to a specialty environmental health clinic when indicated. Quality improvement and a real-time decision support program called Epic SmartPhrase was used to increase provider adherence. Results from patients aged 9-27 months who were seen at the hospital from February 2016 to June 2018 were included, according to the researchers. Their findings were published in Pediatrics.

Over the study period, 634 elevated blood lead levels (BLLs) were recorded. Between February 2016 – when the protocol was distributed – and May 2017 – when Epic SmartPhrase was introduced – a mean of 5% of cases received protocol-based care. After introduction of Epic Smartphase, the rate of adherence to protocol increased to 90%, which was maintained for the rest of the study.

“A reliable system for responding to BLLs is critical for optimizing outcomes for individuals, as well as activating public health systems to reduce environmental lead sources. Using tools within the EHR, we increased provider adherence with published guidelines. Our Epic SmartPhrase could be easily reproduced by other practices using EHRs. Similar strategies could be applied for standardizing the response to other laboratory tests,” the investigators wrote. “This type of intervention could ensure that screenings of all kinds trigger meaningful interventions.”

The study was supported by the Cincinnati Children’s Hospital Medical Center through the All Children Thrive community health initiative; the study authors had no relevant financial disclosures.

SOURCE: Brown CM et al. Pediatrics. 2019 May 9. doi: 10.1542/peds.2018-3085.

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The Poké-sulcus, interchangeable hipsters, and worm PTSD

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Gotta catch ‘em all

In a somewhat unsurprising turn of events, researchers have discovered the exact impact that late-1990s Pokémon obsession had on the human brain. Could Bulbasaur and Charmander really change the way your gray matter works? Pikachu says yes.

Researchers scanned the brains of adults who played Pokémon extensively as children (and possibly as not-children, with the advent of Pokémon Go). They found that, in these adults, the occipitotemporal sulcus region of the brain responded more to images of Pokémon – the original 150, of course – than any other type of image.

The researchers compared this result to “novices” (a.k.a. people who had other hobbies) and noted that novice brains did not have a preference for Pokémon.

Basically, the brain of these experienced players has built them an internal Pokédex, fulfilling the dream of every Pokémaster. Ash Ketchum would be proud.
 

Hipsters don’t all look the same! (Yes, they do)

Slouchy beanie, scruffy beard, maybe a pair of fake spectacles, and definitely flannel – the uniform of the male hipster. Today’s Beatnik-wannabes all praise nonconformism, but what happens when everyone nonconforms the same?

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You get an extremely hilarious threat of lawsuit, that’s what.

The MIT Technology Review published an article about the studies from a mathematician from Brandeis University, who examines how information transmission influences the behavior of a population.

He found that, in general, hipsters in a society initially “act randomly but then undergo a phase transition into a synchronized state.” Despite all their best efforts to push against the mainstream, hipsters eventually sync up with one another and conform to each other.

The article was published with a photo of a man in a beanie, beard, and plaid shirt. The publication soon received an email from a man who claimed he was the person in the photo, and he hadn’t given his consent, and he was upset with the article, calling it a “bit of click-bait about why hipsters all look the same.”

The email-writer angrily threatened legal action … until a quick image check showed that he was not, in fact, the man in the stock photo.

The unnamed hipster slunk away to recover in shame, presumably with organic coffee and a Neutral Milk Hotel album on vinyl.
 

You don’t need a brain to feel fear

PTSD is normally not a laughing matter. It’s a real mental health disorder, and it deserves to be studied. But somehow, a group of researchers from the Hebrew University of Jerusalem found comedy gold researching the disorder by giving PTSD to ... worms.

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Specifically, to Caenorhabditis elegans, a workhorse of biological research. In a study published in Current Biology, the researchers starved their hapless test subjects for a day while spraying them with a scent they normally enjoy. The next day, the worms were fed properly, but when exposed to the same scent, the nematodes went into a defensive mode, showing C. elegans is capable of associative memory.

Because C. elegans only has 302 neurons, it was very simple to find which neurons were affecting their memory and genetically engineer future generations whose “fight or flight” impulse could be activated by switching a light on or off.

Obviously, determining which specific neurons carry associative memory has benefit for the potential treatment of PTSD. We have to wonder though, what do the researchers tell people they do for a living? “Ah, yes, I’m conducting very important research: I make small worms afraid of the light.”

Can’t imagine they get invited to too many parties.
 

 

 

Fly the organ-friendly skies

Much like the proverbial stork, a drone flew 2.8 miles over Baltimore during the early-morning hours of April 19 to deliver a precious cargo.

baranozdemir/iStock/Getty Images Plus

What? No, it was not a baby! Are you nuts?

This drone was, in fact, the first unmanned aircraft to deliver a human donor organ – in this case, a kidney. This next big step for medicine was taken by the team of Joseph Scalea, MD, of the University of Maryland in Baltimore, one of the surgeons who performed the transplant. In earlier test flights, Dr. Scalea’s team was the first to use a drone to transport medical supplies, such as saline and blood tubes, between the launch site and the helipad at the university medical center.

The custom-made drone “needed to meet the rigid medical, technical, and regulatory demands of carrying an unaccompanied deceased donor organ for human transplant.” It has backup propellers, backup motors, dual batteries, and a parachute recovery system, as well as an organ-tracking system, unlike current methods, according to the university.

Our regular reader (Thanks again, Dr Pepper) may remember that LOTME recently reported on San Francisco’s “Poop Patrol” and suggested that the media would hail it as “Uber, but for poop.” Care to take a guess at what Dr. Scalea called his drone?

That right. “Uber for organs.” Sigh. That’s supposed to be our job. No, wait a second!

Okay, here’s one: “organ droner.”

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Gotta catch ‘em all

In a somewhat unsurprising turn of events, researchers have discovered the exact impact that late-1990s Pokémon obsession had on the human brain. Could Bulbasaur and Charmander really change the way your gray matter works? Pikachu says yes.

Researchers scanned the brains of adults who played Pokémon extensively as children (and possibly as not-children, with the advent of Pokémon Go). They found that, in these adults, the occipitotemporal sulcus region of the brain responded more to images of Pokémon – the original 150, of course – than any other type of image.

The researchers compared this result to “novices” (a.k.a. people who had other hobbies) and noted that novice brains did not have a preference for Pokémon.

Basically, the brain of these experienced players has built them an internal Pokédex, fulfilling the dream of every Pokémaster. Ash Ketchum would be proud.
 

Hipsters don’t all look the same! (Yes, they do)

Slouchy beanie, scruffy beard, maybe a pair of fake spectacles, and definitely flannel – the uniform of the male hipster. Today’s Beatnik-wannabes all praise nonconformism, but what happens when everyone nonconforms the same?

master1305/iStock/Getty Images Plus

You get an extremely hilarious threat of lawsuit, that’s what.

The MIT Technology Review published an article about the studies from a mathematician from Brandeis University, who examines how information transmission influences the behavior of a population.

He found that, in general, hipsters in a society initially “act randomly but then undergo a phase transition into a synchronized state.” Despite all their best efforts to push against the mainstream, hipsters eventually sync up with one another and conform to each other.

The article was published with a photo of a man in a beanie, beard, and plaid shirt. The publication soon received an email from a man who claimed he was the person in the photo, and he hadn’t given his consent, and he was upset with the article, calling it a “bit of click-bait about why hipsters all look the same.”

The email-writer angrily threatened legal action … until a quick image check showed that he was not, in fact, the man in the stock photo.

The unnamed hipster slunk away to recover in shame, presumably with organic coffee and a Neutral Milk Hotel album on vinyl.
 

You don’t need a brain to feel fear

PTSD is normally not a laughing matter. It’s a real mental health disorder, and it deserves to be studied. But somehow, a group of researchers from the Hebrew University of Jerusalem found comedy gold researching the disorder by giving PTSD to ... worms.

piola666/iStock/Getty Images Plus

Specifically, to Caenorhabditis elegans, a workhorse of biological research. In a study published in Current Biology, the researchers starved their hapless test subjects for a day while spraying them with a scent they normally enjoy. The next day, the worms were fed properly, but when exposed to the same scent, the nematodes went into a defensive mode, showing C. elegans is capable of associative memory.

Because C. elegans only has 302 neurons, it was very simple to find which neurons were affecting their memory and genetically engineer future generations whose “fight or flight” impulse could be activated by switching a light on or off.

Obviously, determining which specific neurons carry associative memory has benefit for the potential treatment of PTSD. We have to wonder though, what do the researchers tell people they do for a living? “Ah, yes, I’m conducting very important research: I make small worms afraid of the light.”

Can’t imagine they get invited to too many parties.
 

 

 

Fly the organ-friendly skies

Much like the proverbial stork, a drone flew 2.8 miles over Baltimore during the early-morning hours of April 19 to deliver a precious cargo.

baranozdemir/iStock/Getty Images Plus

What? No, it was not a baby! Are you nuts?

This drone was, in fact, the first unmanned aircraft to deliver a human donor organ – in this case, a kidney. This next big step for medicine was taken by the team of Joseph Scalea, MD, of the University of Maryland in Baltimore, one of the surgeons who performed the transplant. In earlier test flights, Dr. Scalea’s team was the first to use a drone to transport medical supplies, such as saline and blood tubes, between the launch site and the helipad at the university medical center.

The custom-made drone “needed to meet the rigid medical, technical, and regulatory demands of carrying an unaccompanied deceased donor organ for human transplant.” It has backup propellers, backup motors, dual batteries, and a parachute recovery system, as well as an organ-tracking system, unlike current methods, according to the university.

Our regular reader (Thanks again, Dr Pepper) may remember that LOTME recently reported on San Francisco’s “Poop Patrol” and suggested that the media would hail it as “Uber, but for poop.” Care to take a guess at what Dr. Scalea called his drone?

That right. “Uber for organs.” Sigh. That’s supposed to be our job. No, wait a second!

Okay, here’s one: “organ droner.”

 

Gotta catch ‘em all

In a somewhat unsurprising turn of events, researchers have discovered the exact impact that late-1990s Pokémon obsession had on the human brain. Could Bulbasaur and Charmander really change the way your gray matter works? Pikachu says yes.

Researchers scanned the brains of adults who played Pokémon extensively as children (and possibly as not-children, with the advent of Pokémon Go). They found that, in these adults, the occipitotemporal sulcus region of the brain responded more to images of Pokémon – the original 150, of course – than any other type of image.

The researchers compared this result to “novices” (a.k.a. people who had other hobbies) and noted that novice brains did not have a preference for Pokémon.

Basically, the brain of these experienced players has built them an internal Pokédex, fulfilling the dream of every Pokémaster. Ash Ketchum would be proud.
 

Hipsters don’t all look the same! (Yes, they do)

Slouchy beanie, scruffy beard, maybe a pair of fake spectacles, and definitely flannel – the uniform of the male hipster. Today’s Beatnik-wannabes all praise nonconformism, but what happens when everyone nonconforms the same?

master1305/iStock/Getty Images Plus

You get an extremely hilarious threat of lawsuit, that’s what.

The MIT Technology Review published an article about the studies from a mathematician from Brandeis University, who examines how information transmission influences the behavior of a population.

He found that, in general, hipsters in a society initially “act randomly but then undergo a phase transition into a synchronized state.” Despite all their best efforts to push against the mainstream, hipsters eventually sync up with one another and conform to each other.

The article was published with a photo of a man in a beanie, beard, and plaid shirt. The publication soon received an email from a man who claimed he was the person in the photo, and he hadn’t given his consent, and he was upset with the article, calling it a “bit of click-bait about why hipsters all look the same.”

The email-writer angrily threatened legal action … until a quick image check showed that he was not, in fact, the man in the stock photo.

The unnamed hipster slunk away to recover in shame, presumably with organic coffee and a Neutral Milk Hotel album on vinyl.
 

You don’t need a brain to feel fear

PTSD is normally not a laughing matter. It’s a real mental health disorder, and it deserves to be studied. But somehow, a group of researchers from the Hebrew University of Jerusalem found comedy gold researching the disorder by giving PTSD to ... worms.

piola666/iStock/Getty Images Plus

Specifically, to Caenorhabditis elegans, a workhorse of biological research. In a study published in Current Biology, the researchers starved their hapless test subjects for a day while spraying them with a scent they normally enjoy. The next day, the worms were fed properly, but when exposed to the same scent, the nematodes went into a defensive mode, showing C. elegans is capable of associative memory.

Because C. elegans only has 302 neurons, it was very simple to find which neurons were affecting their memory and genetically engineer future generations whose “fight or flight” impulse could be activated by switching a light on or off.

Obviously, determining which specific neurons carry associative memory has benefit for the potential treatment of PTSD. We have to wonder though, what do the researchers tell people they do for a living? “Ah, yes, I’m conducting very important research: I make small worms afraid of the light.”

Can’t imagine they get invited to too many parties.
 

 

 

Fly the organ-friendly skies

Much like the proverbial stork, a drone flew 2.8 miles over Baltimore during the early-morning hours of April 19 to deliver a precious cargo.

baranozdemir/iStock/Getty Images Plus

What? No, it was not a baby! Are you nuts?

This drone was, in fact, the first unmanned aircraft to deliver a human donor organ – in this case, a kidney. This next big step for medicine was taken by the team of Joseph Scalea, MD, of the University of Maryland in Baltimore, one of the surgeons who performed the transplant. In earlier test flights, Dr. Scalea’s team was the first to use a drone to transport medical supplies, such as saline and blood tubes, between the launch site and the helipad at the university medical center.

The custom-made drone “needed to meet the rigid medical, technical, and regulatory demands of carrying an unaccompanied deceased donor organ for human transplant.” It has backup propellers, backup motors, dual batteries, and a parachute recovery system, as well as an organ-tracking system, unlike current methods, according to the university.

Our regular reader (Thanks again, Dr Pepper) may remember that LOTME recently reported on San Francisco’s “Poop Patrol” and suggested that the media would hail it as “Uber, but for poop.” Care to take a guess at what Dr. Scalea called his drone?

That right. “Uber for organs.” Sigh. That’s supposed to be our job. No, wait a second!

Okay, here’s one: “organ droner.”

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FDA approves Qternmet XR as adjunct therapy for glycemic improvement in type 2 diabetes

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The Food and Drug Administration has approved Qternmet XR (dapagliflozin/saxagliptin/metformin) as an oral adjunct therapy to diet and exercise for the improvement of glycemic control in patients with type 2 diabetes, according to AstraZeneca.

Wikimedia Commons/FitzColinGerald/Creative Commons License

FDA approval is based on results from a pair of phase 3 trials that tested different combinations of dapagliflozin and saxagliptin in patients with inadequately controlled type 2 diabetes who were also receiving metformin over a 24-week period. In both trials, treatment with dapagliflozin/saxagliptin/metformin decreased hemoglobin A1c by statistically significant amounts, and increased the number of patients with HbA1c levels below 7%

The safety results of Qternmet XR was consistent with each component medication’s known profile.

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The Food and Drug Administration has approved Qternmet XR (dapagliflozin/saxagliptin/metformin) as an oral adjunct therapy to diet and exercise for the improvement of glycemic control in patients with type 2 diabetes, according to AstraZeneca.

Wikimedia Commons/FitzColinGerald/Creative Commons License

FDA approval is based on results from a pair of phase 3 trials that tested different combinations of dapagliflozin and saxagliptin in patients with inadequately controlled type 2 diabetes who were also receiving metformin over a 24-week period. In both trials, treatment with dapagliflozin/saxagliptin/metformin decreased hemoglobin A1c by statistically significant amounts, and increased the number of patients with HbA1c levels below 7%

The safety results of Qternmet XR was consistent with each component medication’s known profile.

The Food and Drug Administration has approved Qternmet XR (dapagliflozin/saxagliptin/metformin) as an oral adjunct therapy to diet and exercise for the improvement of glycemic control in patients with type 2 diabetes, according to AstraZeneca.

Wikimedia Commons/FitzColinGerald/Creative Commons License

FDA approval is based on results from a pair of phase 3 trials that tested different combinations of dapagliflozin and saxagliptin in patients with inadequately controlled type 2 diabetes who were also receiving metformin over a 24-week period. In both trials, treatment with dapagliflozin/saxagliptin/metformin decreased hemoglobin A1c by statistically significant amounts, and increased the number of patients with HbA1c levels below 7%

The safety results of Qternmet XR was consistent with each component medication’s known profile.

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FDA approves Vyndaqel, Vyndamax for amyloidosis-based heart disease

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The Food and Drug Administration has approved tafamidis meglumine (Vyndaqel) and tafamidis (Vyndamax) for the treatment of heart disease caused by transthyretin-mediated amyloidosis.

The disease is caused by the buildup of abnormal deposits of amyloid in the body’s organs and tissues, interfering with normal function, and most often occurs in the heart and nervous system. Symptoms associated with amyloid buildup in the heart include shortness of breath, fatigue, heart failure, loss of consciousness, abnormal heart rhythms, and death.

FDA approval of both drugs was based on results of a clinical trial in which 441 patients with transthyretin-mediated amyloidosis received either tafamidis meglumine or placebo. After a mean of 30 months, patients who received tafamidis meglumine had a higher survival rate and a lower number of cardiovascular-related hospitalizations than did patients in the placebo group.

No drug-associated side effects have yet been identified; however, tafamidis can cause fetal harm when administered to a pregnant woman.

“Transthyretin-mediated amyloidosis is a rare, debilitating, and often fatal disease. The treatments we’re approving today are an important advancement in the treatment of the cardiomyopathy caused by transthyretin-mediated amyloidosis,” said Norman Stockbridge, MD, PhD, director of the Division of Cardiovascular and Renal Drugs in the FDA’s Center for Drug Evaluation and Research.

Find the full press release on the FDA website.

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The Food and Drug Administration has approved tafamidis meglumine (Vyndaqel) and tafamidis (Vyndamax) for the treatment of heart disease caused by transthyretin-mediated amyloidosis.

The disease is caused by the buildup of abnormal deposits of amyloid in the body’s organs and tissues, interfering with normal function, and most often occurs in the heart and nervous system. Symptoms associated with amyloid buildup in the heart include shortness of breath, fatigue, heart failure, loss of consciousness, abnormal heart rhythms, and death.

FDA approval of both drugs was based on results of a clinical trial in which 441 patients with transthyretin-mediated amyloidosis received either tafamidis meglumine or placebo. After a mean of 30 months, patients who received tafamidis meglumine had a higher survival rate and a lower number of cardiovascular-related hospitalizations than did patients in the placebo group.

No drug-associated side effects have yet been identified; however, tafamidis can cause fetal harm when administered to a pregnant woman.

“Transthyretin-mediated amyloidosis is a rare, debilitating, and often fatal disease. The treatments we’re approving today are an important advancement in the treatment of the cardiomyopathy caused by transthyretin-mediated amyloidosis,” said Norman Stockbridge, MD, PhD, director of the Division of Cardiovascular and Renal Drugs in the FDA’s Center for Drug Evaluation and Research.

Find the full press release on the FDA website.

The Food and Drug Administration has approved tafamidis meglumine (Vyndaqel) and tafamidis (Vyndamax) for the treatment of heart disease caused by transthyretin-mediated amyloidosis.

The disease is caused by the buildup of abnormal deposits of amyloid in the body’s organs and tissues, interfering with normal function, and most often occurs in the heart and nervous system. Symptoms associated with amyloid buildup in the heart include shortness of breath, fatigue, heart failure, loss of consciousness, abnormal heart rhythms, and death.

FDA approval of both drugs was based on results of a clinical trial in which 441 patients with transthyretin-mediated amyloidosis received either tafamidis meglumine or placebo. After a mean of 30 months, patients who received tafamidis meglumine had a higher survival rate and a lower number of cardiovascular-related hospitalizations than did patients in the placebo group.

No drug-associated side effects have yet been identified; however, tafamidis can cause fetal harm when administered to a pregnant woman.

“Transthyretin-mediated amyloidosis is a rare, debilitating, and often fatal disease. The treatments we’re approving today are an important advancement in the treatment of the cardiomyopathy caused by transthyretin-mediated amyloidosis,” said Norman Stockbridge, MD, PhD, director of the Division of Cardiovascular and Renal Drugs in the FDA’s Center for Drug Evaluation and Research.

Find the full press release on the FDA website.

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FDA approves first vaccine for prevention of dengue disease

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The Food and Drug Administration has approved Dengvaxia, the first vaccine indicated for the prevention of dengue virus disease caused by all viral serotypes. The vaccine was approved for children aged 9-16 years who live in endemic areas and have previously had laboratory-confirmed dengue disease.

Dengue is endemic in the U.S. territories of American Samoa, Guam, Puerto Rico, and the U.S. Virgin Islands, according to an FDA statement announcing the approval.

While the first infection with dengue virus typically results in either no symptoms or a mild illness that can be mistaken for the flu, a second infection can lead to a more severe form of the disease, including dengue hemorrhagic fever, which can be fatal. About 95% of hospitalized patients with dengue disease have a second dengue virus infection.

FDA approval of Dengvaxia is based on results from three randomized, placebo-controlled studies of 35,000 individuals in dengue-endemic areas. The vaccine was about 76% effective in preventing symptomatic, laboratory-confirmed dengue disease in people aged 9-16 years with a previous dengue diagnosis. The most common adverse events were headache, muscle pain, joint pain, fatigue, injection site pain, and low-grade fever; the frequency of adverse events decreased after each subsequent dose.

“Infection by one type of dengue virus usually provides immunity against that specific serotype, but a subsequent infection by any of the other three serotypes of the virus increases the risk of developing severe dengue disease. ... The FDA’s approval of this vaccine will help protect people previously infected with dengue virus from subsequent development of dengue disease,” Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in the FDA statement.

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The Food and Drug Administration has approved Dengvaxia, the first vaccine indicated for the prevention of dengue virus disease caused by all viral serotypes. The vaccine was approved for children aged 9-16 years who live in endemic areas and have previously had laboratory-confirmed dengue disease.

Dengue is endemic in the U.S. territories of American Samoa, Guam, Puerto Rico, and the U.S. Virgin Islands, according to an FDA statement announcing the approval.

While the first infection with dengue virus typically results in either no symptoms or a mild illness that can be mistaken for the flu, a second infection can lead to a more severe form of the disease, including dengue hemorrhagic fever, which can be fatal. About 95% of hospitalized patients with dengue disease have a second dengue virus infection.

FDA approval of Dengvaxia is based on results from three randomized, placebo-controlled studies of 35,000 individuals in dengue-endemic areas. The vaccine was about 76% effective in preventing symptomatic, laboratory-confirmed dengue disease in people aged 9-16 years with a previous dengue diagnosis. The most common adverse events were headache, muscle pain, joint pain, fatigue, injection site pain, and low-grade fever; the frequency of adverse events decreased after each subsequent dose.

“Infection by one type of dengue virus usually provides immunity against that specific serotype, but a subsequent infection by any of the other three serotypes of the virus increases the risk of developing severe dengue disease. ... The FDA’s approval of this vaccine will help protect people previously infected with dengue virus from subsequent development of dengue disease,” Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in the FDA statement.

 

The Food and Drug Administration has approved Dengvaxia, the first vaccine indicated for the prevention of dengue virus disease caused by all viral serotypes. The vaccine was approved for children aged 9-16 years who live in endemic areas and have previously had laboratory-confirmed dengue disease.

Dengue is endemic in the U.S. territories of American Samoa, Guam, Puerto Rico, and the U.S. Virgin Islands, according to an FDA statement announcing the approval.

While the first infection with dengue virus typically results in either no symptoms or a mild illness that can be mistaken for the flu, a second infection can lead to a more severe form of the disease, including dengue hemorrhagic fever, which can be fatal. About 95% of hospitalized patients with dengue disease have a second dengue virus infection.

FDA approval of Dengvaxia is based on results from three randomized, placebo-controlled studies of 35,000 individuals in dengue-endemic areas. The vaccine was about 76% effective in preventing symptomatic, laboratory-confirmed dengue disease in people aged 9-16 years with a previous dengue diagnosis. The most common adverse events were headache, muscle pain, joint pain, fatigue, injection site pain, and low-grade fever; the frequency of adverse events decreased after each subsequent dose.

“Infection by one type of dengue virus usually provides immunity against that specific serotype, but a subsequent infection by any of the other three serotypes of the virus increases the risk of developing severe dengue disease. ... The FDA’s approval of this vaccine will help protect people previously infected with dengue virus from subsequent development of dengue disease,” Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in the FDA statement.

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FDA approves ivosidenib frontline for certain AML patients

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The Food and Drug Administration has approved ivosidenib (Tibsovo) for newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation in patients who are at least 75 years old or have comorbidities preventing the use of intensive induction chemotherapy.

Wikimedia Commons/FitzColinGerald/Creative Commons License

In July 2018, the FDA approved ivosidenib for adults with relapsed or refractory AML with a susceptible IDH1 mutation.

The latest approval was based on results from an open-label, single-arm, multicenter trial of patients with newly diagnosed AML with an IDH1 mutation. Patients were treated with 500 mg ivosidenib daily until disease progression, development of unacceptable toxicity, or hematopoietic stem cell transplantation; the median age of the 28 patients treated with ivosidenib was 77 years.

Of the 28 patients treated, 12 achieved complete remission or complete remission with partial hematologic recovery; 7 of the 17 transfusion-dependent patients achieved transfusion independence for at least 8 weeks.



The most common adverse events were diarrhea, fatigue, edema, decreased appetite, leukocytosis, nausea, arthralgia, abdominal pain, dyspnea, differentiation syndrome, and myalgia. The drug’s prescribing information includes a boxed warning on the risk of differentiation syndrome.

“The recommended ivosidenib dose is 500 mg orally once daily with or without food until disease progression or unacceptable toxicity. For patients without disease progression or unacceptable toxicity, treatment is recommended for a minimum of 6 months to allow time for clinical response,” the FDA noted.

Find the full press release on the FDA website.

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The Food and Drug Administration has approved ivosidenib (Tibsovo) for newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation in patients who are at least 75 years old or have comorbidities preventing the use of intensive induction chemotherapy.

Wikimedia Commons/FitzColinGerald/Creative Commons License

In July 2018, the FDA approved ivosidenib for adults with relapsed or refractory AML with a susceptible IDH1 mutation.

The latest approval was based on results from an open-label, single-arm, multicenter trial of patients with newly diagnosed AML with an IDH1 mutation. Patients were treated with 500 mg ivosidenib daily until disease progression, development of unacceptable toxicity, or hematopoietic stem cell transplantation; the median age of the 28 patients treated with ivosidenib was 77 years.

Of the 28 patients treated, 12 achieved complete remission or complete remission with partial hematologic recovery; 7 of the 17 transfusion-dependent patients achieved transfusion independence for at least 8 weeks.



The most common adverse events were diarrhea, fatigue, edema, decreased appetite, leukocytosis, nausea, arthralgia, abdominal pain, dyspnea, differentiation syndrome, and myalgia. The drug’s prescribing information includes a boxed warning on the risk of differentiation syndrome.

“The recommended ivosidenib dose is 500 mg orally once daily with or without food until disease progression or unacceptable toxicity. For patients without disease progression or unacceptable toxicity, treatment is recommended for a minimum of 6 months to allow time for clinical response,” the FDA noted.

Find the full press release on the FDA website.

 

The Food and Drug Administration has approved ivosidenib (Tibsovo) for newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation in patients who are at least 75 years old or have comorbidities preventing the use of intensive induction chemotherapy.

Wikimedia Commons/FitzColinGerald/Creative Commons License

In July 2018, the FDA approved ivosidenib for adults with relapsed or refractory AML with a susceptible IDH1 mutation.

The latest approval was based on results from an open-label, single-arm, multicenter trial of patients with newly diagnosed AML with an IDH1 mutation. Patients were treated with 500 mg ivosidenib daily until disease progression, development of unacceptable toxicity, or hematopoietic stem cell transplantation; the median age of the 28 patients treated with ivosidenib was 77 years.

Of the 28 patients treated, 12 achieved complete remission or complete remission with partial hematologic recovery; 7 of the 17 transfusion-dependent patients achieved transfusion independence for at least 8 weeks.



The most common adverse events were diarrhea, fatigue, edema, decreased appetite, leukocytosis, nausea, arthralgia, abdominal pain, dyspnea, differentiation syndrome, and myalgia. The drug’s prescribing information includes a boxed warning on the risk of differentiation syndrome.

“The recommended ivosidenib dose is 500 mg orally once daily with or without food until disease progression or unacceptable toxicity. For patients without disease progression or unacceptable toxicity, treatment is recommended for a minimum of 6 months to allow time for clinical response,” the FDA noted.

Find the full press release on the FDA website.

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