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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.
Cat ladies, heroic music, and Canadian cannabis
Cat ladies: They’re just like you and me
Crazy cat ladies are … not so crazy after all. Bad news for stereotypes, but good news for women who love kitties.
A research team from UCLA observed over 500 pet owners to analyze how people reacted to distress calls from their pets. The investigators also looked at possible links between pet ownership and any mental health or social difficulties.
– meaning cat owners are scientifically proven to be normal.
The study authors specifically stated, “We found no evidence to support the ‘cat lady’ stereotype: cat-owners did not differ from others on self-reported symptoms of depression, anxiety or their experiences in close relationships.” Who would’ve thought?
Music is my hero
If you’re feeling down and need a little more motivation in life, try putting in your headphones and listening to some Hans Zimmer scores. A recently published study found that “heroic” music stimulates motivating and empowering thoughts in listeners.
Researchers had participants listen to heroic and sad music samples and fill out questionnaires after listening. They found that listening to heroic music while the mind starts wandering promotes positive, constructive, and motivating thoughts.
No word yet, though, on whether any of the participants attempted to fly or save some kittens from a tree.
The arms race continues
Intrauterine devices, pacemakers, insulin pumps, gastric bands, coronary stents, car keys: What do all of these things have in common? Right now, you’re probably thinking, “Well, I know what those first five have in common, but … car keys? There’s no way.” Yes way.
Aime Dansby, a software engineer from Dallas, had the key to her Tesla 3 – not the entire key, just the RFID chip from the credit-card-sized valet key – implanted into her arm by a body modification artist named “Pineapple,” according to Car & Driver. Seems she couldn’t get a physician to perform the procedure.
To make the chip “safe” for implantation, Ms. Dansby dissolved the rest of the card with acetone and then had the chip itself encased “in a biopolymer that is safe to use in the body and under the skin,” Popular Mechanics reported.
Ms. Dansby discusses some of her reasoning in a video on YouTube: “They say you can’t, like, start your car with that. It’s not secure. It won’t work. It makes me want to do it more.” We here at LOTME understand and support that kind of thinking, but we also hope that no one ever tells her she can’t start her car by sticking her finger in an electrical socket.
O (THC)anada
It can be difficult to get a precise estimate on the level of drug use within a city or country. Perhaps not surprisingly, many people aren’t entirely forthcoming about their drug habits, legal or not. But their poop … the poop never lies.
That’s why Stats Canada, in an effort to find new ways to collect data relating to the legalization of cannabis, conducted a survey of wastewater from five Canadian cities: Halifax, Montreal, Toronto, Edmonton, and Vancouver. In other words, they looked through the poop of about 8.4 million people to find out what drugs they preferred, gathering information on cannabis, cocaine, opioids, and methamphetamine.
Despite its legal status, cannabis usage was not uniform across the country, as Halifax and Montreal wastewater had THC levels more than twice as high as the other three cities. Stats Canada noted that Nova Scotia has higher-than-average cannabis usage, but Quebec as a whole has lower-than-average usage. Apparently the people of Montreal just really like their weed.
In fact, only cocaine showed no geographic bent. Opioids were significantly less popular in Toronto and Montreal, and methamphetamine was much more common in Edmonton and Vancouver.
In the end, Stats Canada concluded that wastewater analysis was an effective way to test drug usage, though we suspect they may have come to a different conclusion had they made anyone other than a bunch of polite Canadians sample the sewage of over 8 million people.
Cat ladies: They’re just like you and me
Crazy cat ladies are … not so crazy after all. Bad news for stereotypes, but good news for women who love kitties.
A research team from UCLA observed over 500 pet owners to analyze how people reacted to distress calls from their pets. The investigators also looked at possible links between pet ownership and any mental health or social difficulties.
– meaning cat owners are scientifically proven to be normal.
The study authors specifically stated, “We found no evidence to support the ‘cat lady’ stereotype: cat-owners did not differ from others on self-reported symptoms of depression, anxiety or their experiences in close relationships.” Who would’ve thought?
Music is my hero
If you’re feeling down and need a little more motivation in life, try putting in your headphones and listening to some Hans Zimmer scores. A recently published study found that “heroic” music stimulates motivating and empowering thoughts in listeners.
Researchers had participants listen to heroic and sad music samples and fill out questionnaires after listening. They found that listening to heroic music while the mind starts wandering promotes positive, constructive, and motivating thoughts.
No word yet, though, on whether any of the participants attempted to fly or save some kittens from a tree.
The arms race continues
Intrauterine devices, pacemakers, insulin pumps, gastric bands, coronary stents, car keys: What do all of these things have in common? Right now, you’re probably thinking, “Well, I know what those first five have in common, but … car keys? There’s no way.” Yes way.
Aime Dansby, a software engineer from Dallas, had the key to her Tesla 3 – not the entire key, just the RFID chip from the credit-card-sized valet key – implanted into her arm by a body modification artist named “Pineapple,” according to Car & Driver. Seems she couldn’t get a physician to perform the procedure.
To make the chip “safe” for implantation, Ms. Dansby dissolved the rest of the card with acetone and then had the chip itself encased “in a biopolymer that is safe to use in the body and under the skin,” Popular Mechanics reported.
Ms. Dansby discusses some of her reasoning in a video on YouTube: “They say you can’t, like, start your car with that. It’s not secure. It won’t work. It makes me want to do it more.” We here at LOTME understand and support that kind of thinking, but we also hope that no one ever tells her she can’t start her car by sticking her finger in an electrical socket.
O (THC)anada
It can be difficult to get a precise estimate on the level of drug use within a city or country. Perhaps not surprisingly, many people aren’t entirely forthcoming about their drug habits, legal or not. But their poop … the poop never lies.
That’s why Stats Canada, in an effort to find new ways to collect data relating to the legalization of cannabis, conducted a survey of wastewater from five Canadian cities: Halifax, Montreal, Toronto, Edmonton, and Vancouver. In other words, they looked through the poop of about 8.4 million people to find out what drugs they preferred, gathering information on cannabis, cocaine, opioids, and methamphetamine.
Despite its legal status, cannabis usage was not uniform across the country, as Halifax and Montreal wastewater had THC levels more than twice as high as the other three cities. Stats Canada noted that Nova Scotia has higher-than-average cannabis usage, but Quebec as a whole has lower-than-average usage. Apparently the people of Montreal just really like their weed.
In fact, only cocaine showed no geographic bent. Opioids were significantly less popular in Toronto and Montreal, and methamphetamine was much more common in Edmonton and Vancouver.
In the end, Stats Canada concluded that wastewater analysis was an effective way to test drug usage, though we suspect they may have come to a different conclusion had they made anyone other than a bunch of polite Canadians sample the sewage of over 8 million people.
Cat ladies: They’re just like you and me
Crazy cat ladies are … not so crazy after all. Bad news for stereotypes, but good news for women who love kitties.
A research team from UCLA observed over 500 pet owners to analyze how people reacted to distress calls from their pets. The investigators also looked at possible links between pet ownership and any mental health or social difficulties.
– meaning cat owners are scientifically proven to be normal.
The study authors specifically stated, “We found no evidence to support the ‘cat lady’ stereotype: cat-owners did not differ from others on self-reported symptoms of depression, anxiety or their experiences in close relationships.” Who would’ve thought?
Music is my hero
If you’re feeling down and need a little more motivation in life, try putting in your headphones and listening to some Hans Zimmer scores. A recently published study found that “heroic” music stimulates motivating and empowering thoughts in listeners.
Researchers had participants listen to heroic and sad music samples and fill out questionnaires after listening. They found that listening to heroic music while the mind starts wandering promotes positive, constructive, and motivating thoughts.
No word yet, though, on whether any of the participants attempted to fly or save some kittens from a tree.
The arms race continues
Intrauterine devices, pacemakers, insulin pumps, gastric bands, coronary stents, car keys: What do all of these things have in common? Right now, you’re probably thinking, “Well, I know what those first five have in common, but … car keys? There’s no way.” Yes way.
Aime Dansby, a software engineer from Dallas, had the key to her Tesla 3 – not the entire key, just the RFID chip from the credit-card-sized valet key – implanted into her arm by a body modification artist named “Pineapple,” according to Car & Driver. Seems she couldn’t get a physician to perform the procedure.
To make the chip “safe” for implantation, Ms. Dansby dissolved the rest of the card with acetone and then had the chip itself encased “in a biopolymer that is safe to use in the body and under the skin,” Popular Mechanics reported.
Ms. Dansby discusses some of her reasoning in a video on YouTube: “They say you can’t, like, start your car with that. It’s not secure. It won’t work. It makes me want to do it more.” We here at LOTME understand and support that kind of thinking, but we also hope that no one ever tells her she can’t start her car by sticking her finger in an electrical socket.
O (THC)anada
It can be difficult to get a precise estimate on the level of drug use within a city or country. Perhaps not surprisingly, many people aren’t entirely forthcoming about their drug habits, legal or not. But their poop … the poop never lies.
That’s why Stats Canada, in an effort to find new ways to collect data relating to the legalization of cannabis, conducted a survey of wastewater from five Canadian cities: Halifax, Montreal, Toronto, Edmonton, and Vancouver. In other words, they looked through the poop of about 8.4 million people to find out what drugs they preferred, gathering information on cannabis, cocaine, opioids, and methamphetamine.
Despite its legal status, cannabis usage was not uniform across the country, as Halifax and Montreal wastewater had THC levels more than twice as high as the other three cities. Stats Canada noted that Nova Scotia has higher-than-average cannabis usage, but Quebec as a whole has lower-than-average usage. Apparently the people of Montreal just really like their weed.
In fact, only cocaine showed no geographic bent. Opioids were significantly less popular in Toronto and Montreal, and methamphetamine was much more common in Edmonton and Vancouver.
In the end, Stats Canada concluded that wastewater analysis was an effective way to test drug usage, though we suspect they may have come to a different conclusion had they made anyone other than a bunch of polite Canadians sample the sewage of over 8 million people.
USPSTF issues draft recommendation statement for HCV screening in adults
and now suggests that all adults aged 18-79 years receive screening.
This proposal represents an update and expansion of its current recommendation for screening for HCV infection. The draft recommendation incorporates new evidence and would replace the recommendation made in 2013, which calls for screening in persons at high risk for infection and one-time screening in adults born between 1945 and 1965 (Grade B).
“Today, more people are infected with hepatitis C than there were a decade ago, but there are now better treatments available. The evidence now shows more people can benefit from screening; therefore, we are recommending to screen all adults ages 18-79 for hepatitis C,” task force chair Douglas K. Owens, MD, MS, said in a bulletin issued by the USPSTF.
To update the previous recommendation, the USPSTF conducted a systematic review that included a total of 97 studies. No direct evidence was found regarding the benefits of HCV screening versus no screening or repeat versus one-time screening, and no new studies analyzed the psychological and social consequences of HCV screening.
Evidence concerning direct-acting antiviral (DAA) treatment was more compelling given that 49 trials found DAA therapy to be associated with pooled sustained virologic response (SVR) rates between 95.5% and 98.9% across genotypes. The rate of serious adverse events caused by DAA treatment was 1.9%, and the discontinuation of treatment because of adverse events was 0.4%. In seven trials involving adolescents, SVR rates after antiviral treatment were similar to those in adults.
Achieving an SVR after DAA treatment was associated with a decreased risk in those treated of all-cause mortality (hazard ratio, 0.40; 95% confidence interval, 0.28-0.56), liver mortality (HR, 0.11; 95% CI, 0.04-0.27), cirrhosis (HR, 0.36; 95% CI, 0.33-0.40), and hepatocellular carcinoma (HR, 0.29; 95% CI, 0.23-0.38), compared with those who did not respond.
Because of the evidence collected, the USPSTF issued a B recommendation for HCV screening in adults and recommended screening for all people aged 18-79 years in the draft recommendation statement. “Clinicians may want to consider screening in adolescents younger than age 18 years and in adults older than age 79 years who are at high risk [for HCV],” the proposal says.
The draft recommendation statement and evidence review is available at www.uspreventiveservicestaskforce.org. The public comment period will last until Sept. 23, 2019.
Help educate your patients about hepatitis C, their risks and treatment options using AGA patient education, which can be found in the GI Patient Center at https://www.gastro.org/practice-guidance/gi-patient-center/topic/hepatitis-c-hcv.
and now suggests that all adults aged 18-79 years receive screening.
This proposal represents an update and expansion of its current recommendation for screening for HCV infection. The draft recommendation incorporates new evidence and would replace the recommendation made in 2013, which calls for screening in persons at high risk for infection and one-time screening in adults born between 1945 and 1965 (Grade B).
“Today, more people are infected with hepatitis C than there were a decade ago, but there are now better treatments available. The evidence now shows more people can benefit from screening; therefore, we are recommending to screen all adults ages 18-79 for hepatitis C,” task force chair Douglas K. Owens, MD, MS, said in a bulletin issued by the USPSTF.
To update the previous recommendation, the USPSTF conducted a systematic review that included a total of 97 studies. No direct evidence was found regarding the benefits of HCV screening versus no screening or repeat versus one-time screening, and no new studies analyzed the psychological and social consequences of HCV screening.
Evidence concerning direct-acting antiviral (DAA) treatment was more compelling given that 49 trials found DAA therapy to be associated with pooled sustained virologic response (SVR) rates between 95.5% and 98.9% across genotypes. The rate of serious adverse events caused by DAA treatment was 1.9%, and the discontinuation of treatment because of adverse events was 0.4%. In seven trials involving adolescents, SVR rates after antiviral treatment were similar to those in adults.
Achieving an SVR after DAA treatment was associated with a decreased risk in those treated of all-cause mortality (hazard ratio, 0.40; 95% confidence interval, 0.28-0.56), liver mortality (HR, 0.11; 95% CI, 0.04-0.27), cirrhosis (HR, 0.36; 95% CI, 0.33-0.40), and hepatocellular carcinoma (HR, 0.29; 95% CI, 0.23-0.38), compared with those who did not respond.
Because of the evidence collected, the USPSTF issued a B recommendation for HCV screening in adults and recommended screening for all people aged 18-79 years in the draft recommendation statement. “Clinicians may want to consider screening in adolescents younger than age 18 years and in adults older than age 79 years who are at high risk [for HCV],” the proposal says.
The draft recommendation statement and evidence review is available at www.uspreventiveservicestaskforce.org. The public comment period will last until Sept. 23, 2019.
Help educate your patients about hepatitis C, their risks and treatment options using AGA patient education, which can be found in the GI Patient Center at https://www.gastro.org/practice-guidance/gi-patient-center/topic/hepatitis-c-hcv.
and now suggests that all adults aged 18-79 years receive screening.
This proposal represents an update and expansion of its current recommendation for screening for HCV infection. The draft recommendation incorporates new evidence and would replace the recommendation made in 2013, which calls for screening in persons at high risk for infection and one-time screening in adults born between 1945 and 1965 (Grade B).
“Today, more people are infected with hepatitis C than there were a decade ago, but there are now better treatments available. The evidence now shows more people can benefit from screening; therefore, we are recommending to screen all adults ages 18-79 for hepatitis C,” task force chair Douglas K. Owens, MD, MS, said in a bulletin issued by the USPSTF.
To update the previous recommendation, the USPSTF conducted a systematic review that included a total of 97 studies. No direct evidence was found regarding the benefits of HCV screening versus no screening or repeat versus one-time screening, and no new studies analyzed the psychological and social consequences of HCV screening.
Evidence concerning direct-acting antiviral (DAA) treatment was more compelling given that 49 trials found DAA therapy to be associated with pooled sustained virologic response (SVR) rates between 95.5% and 98.9% across genotypes. The rate of serious adverse events caused by DAA treatment was 1.9%, and the discontinuation of treatment because of adverse events was 0.4%. In seven trials involving adolescents, SVR rates after antiviral treatment were similar to those in adults.
Achieving an SVR after DAA treatment was associated with a decreased risk in those treated of all-cause mortality (hazard ratio, 0.40; 95% confidence interval, 0.28-0.56), liver mortality (HR, 0.11; 95% CI, 0.04-0.27), cirrhosis (HR, 0.36; 95% CI, 0.33-0.40), and hepatocellular carcinoma (HR, 0.29; 95% CI, 0.23-0.38), compared with those who did not respond.
Because of the evidence collected, the USPSTF issued a B recommendation for HCV screening in adults and recommended screening for all people aged 18-79 years in the draft recommendation statement. “Clinicians may want to consider screening in adolescents younger than age 18 years and in adults older than age 79 years who are at high risk [for HCV],” the proposal says.
The draft recommendation statement and evidence review is available at www.uspreventiveservicestaskforce.org. The public comment period will last until Sept. 23, 2019.
Help educate your patients about hepatitis C, their risks and treatment options using AGA patient education, which can be found in the GI Patient Center at https://www.gastro.org/practice-guidance/gi-patient-center/topic/hepatitis-c-hcv.
USPSTF issues draft recommendation statement for HCV screening in adults
and now suggests that all adults aged 18-79 years receive screening.
This proposal represents an update and expansion of its current recommendation for screening for HCV infection. The draft recommendation incorporates new evidence and would replace the recommendation made in 2013, which calls for screening in persons at high risk for infection and one-time screening in adults born between 1945 and 1965 (Grade B).
“Today, more people are infected with hepatitis C than there were a decade ago, but there are now better treatments available. The evidence now shows more people can benefit from screening; therefore, we are recommending to screen all adults ages 18-79 for hepatitis C,” task force chair Douglas K. Owens, MD, MS, said in a bulletin issued by the USPSTF.
To update the previous recommendation, the USPSTF conducted a systematic review that included a total of 97 studies. No direct evidence was found regarding the benefits of HCV screening versus no screening or repeat versus one-time screening, and no new studies analyzed the psychological and social consequences of HCV screening.
Evidence concerning direct-acting antiviral (DAA) treatment was more compelling given that 49 trials found DAA therapy to be associated with pooled sustained virologic response (SVR) rates between 95.5% and 98.9% across genotypes. The rate of serious adverse events caused by DAA treatment was 1.9%, and the discontinuation of treatment because of adverse events was 0.4%. In seven trials involving adolescents, SVR rates after antiviral treatment were similar to those in adults.
Achieving an SVR after DAA treatment was associated with a decreased risk in those treated of all-cause mortality (hazard ratio, 0.40; 95% confidence interval, 0.28-0.56), liver mortality (HR, 0.11; 95% CI, 0.04-0.27), cirrhosis (HR, 0.36; 95% CI, 0.33-0.40), and hepatocellular carcinoma (HR, 0.29; 95% CI, 0.23-0.38), compared with those who did not respond.
Because of the evidence collected, the USPSTF issued a B recommendation for HCV screening in adults and recommended screening for all people aged 18-79 years in the draft recommendation statement. “Clinicians may want to consider screening in adolescents younger than age 18 years and in adults older than age 79 years who are at high risk [for HCV],” the proposal says.
The draft recommendation statement and evidence review is available at www.uspreventiveservicestaskforce.org. The public comment period will last until Sept. 23, 2019.
and now suggests that all adults aged 18-79 years receive screening.
This proposal represents an update and expansion of its current recommendation for screening for HCV infection. The draft recommendation incorporates new evidence and would replace the recommendation made in 2013, which calls for screening in persons at high risk for infection and one-time screening in adults born between 1945 and 1965 (Grade B).
“Today, more people are infected with hepatitis C than there were a decade ago, but there are now better treatments available. The evidence now shows more people can benefit from screening; therefore, we are recommending to screen all adults ages 18-79 for hepatitis C,” task force chair Douglas K. Owens, MD, MS, said in a bulletin issued by the USPSTF.
To update the previous recommendation, the USPSTF conducted a systematic review that included a total of 97 studies. No direct evidence was found regarding the benefits of HCV screening versus no screening or repeat versus one-time screening, and no new studies analyzed the psychological and social consequences of HCV screening.
Evidence concerning direct-acting antiviral (DAA) treatment was more compelling given that 49 trials found DAA therapy to be associated with pooled sustained virologic response (SVR) rates between 95.5% and 98.9% across genotypes. The rate of serious adverse events caused by DAA treatment was 1.9%, and the discontinuation of treatment because of adverse events was 0.4%. In seven trials involving adolescents, SVR rates after antiviral treatment were similar to those in adults.
Achieving an SVR after DAA treatment was associated with a decreased risk in those treated of all-cause mortality (hazard ratio, 0.40; 95% confidence interval, 0.28-0.56), liver mortality (HR, 0.11; 95% CI, 0.04-0.27), cirrhosis (HR, 0.36; 95% CI, 0.33-0.40), and hepatocellular carcinoma (HR, 0.29; 95% CI, 0.23-0.38), compared with those who did not respond.
Because of the evidence collected, the USPSTF issued a B recommendation for HCV screening in adults and recommended screening for all people aged 18-79 years in the draft recommendation statement. “Clinicians may want to consider screening in adolescents younger than age 18 years and in adults older than age 79 years who are at high risk [for HCV],” the proposal says.
The draft recommendation statement and evidence review is available at www.uspreventiveservicestaskforce.org. The public comment period will last until Sept. 23, 2019.
and now suggests that all adults aged 18-79 years receive screening.
This proposal represents an update and expansion of its current recommendation for screening for HCV infection. The draft recommendation incorporates new evidence and would replace the recommendation made in 2013, which calls for screening in persons at high risk for infection and one-time screening in adults born between 1945 and 1965 (Grade B).
“Today, more people are infected with hepatitis C than there were a decade ago, but there are now better treatments available. The evidence now shows more people can benefit from screening; therefore, we are recommending to screen all adults ages 18-79 for hepatitis C,” task force chair Douglas K. Owens, MD, MS, said in a bulletin issued by the USPSTF.
To update the previous recommendation, the USPSTF conducted a systematic review that included a total of 97 studies. No direct evidence was found regarding the benefits of HCV screening versus no screening or repeat versus one-time screening, and no new studies analyzed the psychological and social consequences of HCV screening.
Evidence concerning direct-acting antiviral (DAA) treatment was more compelling given that 49 trials found DAA therapy to be associated with pooled sustained virologic response (SVR) rates between 95.5% and 98.9% across genotypes. The rate of serious adverse events caused by DAA treatment was 1.9%, and the discontinuation of treatment because of adverse events was 0.4%. In seven trials involving adolescents, SVR rates after antiviral treatment were similar to those in adults.
Achieving an SVR after DAA treatment was associated with a decreased risk in those treated of all-cause mortality (hazard ratio, 0.40; 95% confidence interval, 0.28-0.56), liver mortality (HR, 0.11; 95% CI, 0.04-0.27), cirrhosis (HR, 0.36; 95% CI, 0.33-0.40), and hepatocellular carcinoma (HR, 0.29; 95% CI, 0.23-0.38), compared with those who did not respond.
Because of the evidence collected, the USPSTF issued a B recommendation for HCV screening in adults and recommended screening for all people aged 18-79 years in the draft recommendation statement. “Clinicians may want to consider screening in adolescents younger than age 18 years and in adults older than age 79 years who are at high risk [for HCV],” the proposal says.
The draft recommendation statement and evidence review is available at www.uspreventiveservicestaskforce.org. The public comment period will last until Sept. 23, 2019.
FDA approves Taltz for treatment of ankylosing spondylitis
(AS), according to a press release from Eli Lilly.
AS is the third indication for ixekizumab, along with moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and active psoriatic arthritis in adults.
Approval of the humanized interleukin-17A antagonist was based on results from a pair of randomized, double-blind, placebo-controlled, phase 3 studies involving 657 adult patients with active AS: the COAST-V trial in those naive to biologic disease-modifying antirheumatic drugs (bDMARDs) and the COAST-W trial in those who were intolerant or had inadequate response to tumor necrosis factor (TNF) inhibitors. The primary endpoint in both trials was achievement of 40% improvement in Assessment of Spondyloarthritis International Society criteria (ASAS40) at 16 weeks, compared with placebo.
In COAST-V, 48% of patients who received ixekizumab achieved ASAS40, compared with 18% of controls (P less than .0001). In COAST-W, 25% of patients who received ixekizumab achieved ASAS40 versus 13% of controls (P less than .05). The adverse events reported during both trials were consistent with the safety profile in patients who receive ixekizumab for the treatment of plaque psoriasis, including injection-site reactions, upper respiratory tract infections, nausea, and tinea infections.
“Results from the phase 3 clinical trial program in ankylosing spondylitis show that Taltz helped reduce pain and inflammation and improve function in patients who had never been treated with a bDMARD as well as those who previously failed TNF inhibitors. This approval is an important milestone for patients and physicians who are looking for a much-needed alternative to address symptoms of AS,” said Philip Mease, MD, of Providence St. Joseph Health and the University of Washington, both in Seattle.
(AS), according to a press release from Eli Lilly.
AS is the third indication for ixekizumab, along with moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and active psoriatic arthritis in adults.
Approval of the humanized interleukin-17A antagonist was based on results from a pair of randomized, double-blind, placebo-controlled, phase 3 studies involving 657 adult patients with active AS: the COAST-V trial in those naive to biologic disease-modifying antirheumatic drugs (bDMARDs) and the COAST-W trial in those who were intolerant or had inadequate response to tumor necrosis factor (TNF) inhibitors. The primary endpoint in both trials was achievement of 40% improvement in Assessment of Spondyloarthritis International Society criteria (ASAS40) at 16 weeks, compared with placebo.
In COAST-V, 48% of patients who received ixekizumab achieved ASAS40, compared with 18% of controls (P less than .0001). In COAST-W, 25% of patients who received ixekizumab achieved ASAS40 versus 13% of controls (P less than .05). The adverse events reported during both trials were consistent with the safety profile in patients who receive ixekizumab for the treatment of plaque psoriasis, including injection-site reactions, upper respiratory tract infections, nausea, and tinea infections.
“Results from the phase 3 clinical trial program in ankylosing spondylitis show that Taltz helped reduce pain and inflammation and improve function in patients who had never been treated with a bDMARD as well as those who previously failed TNF inhibitors. This approval is an important milestone for patients and physicians who are looking for a much-needed alternative to address symptoms of AS,” said Philip Mease, MD, of Providence St. Joseph Health and the University of Washington, both in Seattle.
(AS), according to a press release from Eli Lilly.
AS is the third indication for ixekizumab, along with moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and active psoriatic arthritis in adults.
Approval of the humanized interleukin-17A antagonist was based on results from a pair of randomized, double-blind, placebo-controlled, phase 3 studies involving 657 adult patients with active AS: the COAST-V trial in those naive to biologic disease-modifying antirheumatic drugs (bDMARDs) and the COAST-W trial in those who were intolerant or had inadequate response to tumor necrosis factor (TNF) inhibitors. The primary endpoint in both trials was achievement of 40% improvement in Assessment of Spondyloarthritis International Society criteria (ASAS40) at 16 weeks, compared with placebo.
In COAST-V, 48% of patients who received ixekizumab achieved ASAS40, compared with 18% of controls (P less than .0001). In COAST-W, 25% of patients who received ixekizumab achieved ASAS40 versus 13% of controls (P less than .05). The adverse events reported during both trials were consistent with the safety profile in patients who receive ixekizumab for the treatment of plaque psoriasis, including injection-site reactions, upper respiratory tract infections, nausea, and tinea infections.
“Results from the phase 3 clinical trial program in ankylosing spondylitis show that Taltz helped reduce pain and inflammation and improve function in patients who had never been treated with a bDMARD as well as those who previously failed TNF inhibitors. This approval is an important milestone for patients and physicians who are looking for a much-needed alternative to address symptoms of AS,” said Philip Mease, MD, of Providence St. Joseph Health and the University of Washington, both in Seattle.
Selfie hate, emoji love, and sexy lichen
Stop the selfies
If you’re a selfie aficionado, this is crucial information. People hate your selfies, and people hate you.
Okay, maybe that’s being a little aggressive, but a new study from Washington State University has shown that, if you’re a chronic selfie poster, people (aka your loyal Instagram audience) are more likely to view you as unlikable, unsuccessful, insecure, and closed off to new experiences.
The study was born from the idea that chronic selfie takers are more narcissistic than the rest of us. Chris Barry, PhD, the lead author of this study, conducted research into that hypothesis and found inconclusive results: Selfie prevalence just wasn’t indicative of personality. However, Dr. Barry realized there may be a stronger link between the amount of selfies posted and how people (whom the selfies are forced upon) perceive the selfie taker. [Editor’s note: I am more tired of reading the word “selfie” than of seeing them at this point.]
Study participants were asked to rate the Instagram profiles of 30 undergrad students on attributes such as low self-esteem, self-absorption, and success. The profiles with more posed photos were viewed as being more adventurous, more outgoing, and having high self-esteem, while the reverse was true for profiles with lots of selfies. And for the men trying online dating: Flexing-in-the-mirror selfies were viewed extra negatively.
So what have we learned from this all-important selfie study? If you want to step up your online profile, start by deleting a few of those selfies. Send them to Grandma instead, who will really appreciate your pretty face.
Emoji emotion
You’re setting up your online dating profile. You’ve removed all the selfies and have only the most flattering posed photos of yourself: with your dog, climbing a mountain, at the beach, all the greatest hits. You’ve been messaging the ladies nonstop, impressing them with your witty wordplay and impeccable spelling. But so far, not much is happening. What gives? According to a study from the Kinsey Institute, you’ve got to use more emojis.
Surveying more than 5,000 adults, researchers found that frequent emoji use predicted more first dates and more frequent sexual activity. The findings suggest that
Is an emoji worth a thousand words? For some, apparently. The authors noted that emojis can be used in addition to words to strategically infuse digital communication with expression and emotion that typed words often lack. For many, a smiley emoji carries more emotional weight than writing that you’re happy. If you’re looking to spice up your love life, say it with emojis instead. And if you’re not well-versed in emoji speak, make sure to look up the meaning of the eggplant emoji before you use it.
The nomination would have been enough, really
We here at LOTME love a good survey ... Okay, most of us here at LOTME love a good survey ... All right, it looks like three out of four LOTME staffers surveyed are quite fond of a good survey.
Here, now, finally, is some news about a survey. The good folks at Crestline – whose custom-imprinted promotional products “bring your logo to life!” – asked 1,630 U.S. residents about “America’s Most Memorable Mascots.” The respondents were asked to identify and rate 82 characters representing the best of American marketing, including Colonel Sanders, Little Debbie, Chuck E. Cheese, and the Aflac duck.
In a sweep of epic proportions, the top ranking in each of five measures – least likable, least persuasive, least trustworthy, most annoying, and most creepy – went to the same character: Mr. Mucus, the face of the Mucinex brand.
After hearing the big news, Elyse Altabet, marketing director for Mucinex, had this to say to FiercePharma: “We agree that Mr. Mucus is thoroughly annoying – after all, he is the personification of your most annoying cold. Far from being our mascot, though, it is our sole goal to help get rid of him whenever he tries to invade our lives. Which is why every American knows that when sick happens, we reach for Mucinex.”
Not so sexy after all
Another day, another organism being marketed as an aphrodisiac thanks to some dubious science, according to a report from the New Zealand Newsroom. To be fair, though, advertising a product called sexy pavement lichen as a natural male enhancement isn’t the worst-sounding idea in the world.
The sexy lichen in question, Xanthoparmelia scabrosa, most commonly found in Australia and New Zealand, isn’t that much more attractive than any other lichen. It’s more of a nuisance than anything else, as it loves to grow in pavement and makes roads covered in the stuff dangerously slick when it rains.
As for any benefit as an aphrodisiac, the plant does contain a PDE5 inhibitor, which can inhibit an enzyme causing impotence but may also be toxic on its own. Plus you’ll be getting a dose of such heavy metals as copper, lead, cadmium, mercury, and basically anything else you’d find in asphalt.
The “legitimate” business people involved claim to grind up the actual lichen, and their product is then marketed as an ancient Chinese therapy for erectile dysfunction. A thriving market has been built around sexy pavement lichen, with thousands of tons available on websites such as Alibaba at the premium price of $100 per kg.
In reality, people are buying a combination of Viagra and grass clippings, as harvesting that much lichen would be both unfeasible and unsustainable, according to the Newsroom report. Sadly, it seems that “legitimate” business people have once again let us all down. But hey, at least they’re not selling poisonous lichen. 
Stop the selfies
If you’re a selfie aficionado, this is crucial information. People hate your selfies, and people hate you.
Okay, maybe that’s being a little aggressive, but a new study from Washington State University has shown that, if you’re a chronic selfie poster, people (aka your loyal Instagram audience) are more likely to view you as unlikable, unsuccessful, insecure, and closed off to new experiences.
The study was born from the idea that chronic selfie takers are more narcissistic than the rest of us. Chris Barry, PhD, the lead author of this study, conducted research into that hypothesis and found inconclusive results: Selfie prevalence just wasn’t indicative of personality. However, Dr. Barry realized there may be a stronger link between the amount of selfies posted and how people (whom the selfies are forced upon) perceive the selfie taker. [Editor’s note: I am more tired of reading the word “selfie” than of seeing them at this point.]
Study participants were asked to rate the Instagram profiles of 30 undergrad students on attributes such as low self-esteem, self-absorption, and success. The profiles with more posed photos were viewed as being more adventurous, more outgoing, and having high self-esteem, while the reverse was true for profiles with lots of selfies. And for the men trying online dating: Flexing-in-the-mirror selfies were viewed extra negatively.
So what have we learned from this all-important selfie study? If you want to step up your online profile, start by deleting a few of those selfies. Send them to Grandma instead, who will really appreciate your pretty face.
Emoji emotion
You’re setting up your online dating profile. You’ve removed all the selfies and have only the most flattering posed photos of yourself: with your dog, climbing a mountain, at the beach, all the greatest hits. You’ve been messaging the ladies nonstop, impressing them with your witty wordplay and impeccable spelling. But so far, not much is happening. What gives? According to a study from the Kinsey Institute, you’ve got to use more emojis.
Surveying more than 5,000 adults, researchers found that frequent emoji use predicted more first dates and more frequent sexual activity. The findings suggest that
Is an emoji worth a thousand words? For some, apparently. The authors noted that emojis can be used in addition to words to strategically infuse digital communication with expression and emotion that typed words often lack. For many, a smiley emoji carries more emotional weight than writing that you’re happy. If you’re looking to spice up your love life, say it with emojis instead. And if you’re not well-versed in emoji speak, make sure to look up the meaning of the eggplant emoji before you use it.
The nomination would have been enough, really
We here at LOTME love a good survey ... Okay, most of us here at LOTME love a good survey ... All right, it looks like three out of four LOTME staffers surveyed are quite fond of a good survey.
Here, now, finally, is some news about a survey. The good folks at Crestline – whose custom-imprinted promotional products “bring your logo to life!” – asked 1,630 U.S. residents about “America’s Most Memorable Mascots.” The respondents were asked to identify and rate 82 characters representing the best of American marketing, including Colonel Sanders, Little Debbie, Chuck E. Cheese, and the Aflac duck.
In a sweep of epic proportions, the top ranking in each of five measures – least likable, least persuasive, least trustworthy, most annoying, and most creepy – went to the same character: Mr. Mucus, the face of the Mucinex brand.
After hearing the big news, Elyse Altabet, marketing director for Mucinex, had this to say to FiercePharma: “We agree that Mr. Mucus is thoroughly annoying – after all, he is the personification of your most annoying cold. Far from being our mascot, though, it is our sole goal to help get rid of him whenever he tries to invade our lives. Which is why every American knows that when sick happens, we reach for Mucinex.”
Not so sexy after all
Another day, another organism being marketed as an aphrodisiac thanks to some dubious science, according to a report from the New Zealand Newsroom. To be fair, though, advertising a product called sexy pavement lichen as a natural male enhancement isn’t the worst-sounding idea in the world.
The sexy lichen in question, Xanthoparmelia scabrosa, most commonly found in Australia and New Zealand, isn’t that much more attractive than any other lichen. It’s more of a nuisance than anything else, as it loves to grow in pavement and makes roads covered in the stuff dangerously slick when it rains.
As for any benefit as an aphrodisiac, the plant does contain a PDE5 inhibitor, which can inhibit an enzyme causing impotence but may also be toxic on its own. Plus you’ll be getting a dose of such heavy metals as copper, lead, cadmium, mercury, and basically anything else you’d find in asphalt.
The “legitimate” business people involved claim to grind up the actual lichen, and their product is then marketed as an ancient Chinese therapy for erectile dysfunction. A thriving market has been built around sexy pavement lichen, with thousands of tons available on websites such as Alibaba at the premium price of $100 per kg.
In reality, people are buying a combination of Viagra and grass clippings, as harvesting that much lichen would be both unfeasible and unsustainable, according to the Newsroom report. Sadly, it seems that “legitimate” business people have once again let us all down. But hey, at least they’re not selling poisonous lichen.
Stop the selfies
If you’re a selfie aficionado, this is crucial information. People hate your selfies, and people hate you.
Okay, maybe that’s being a little aggressive, but a new study from Washington State University has shown that, if you’re a chronic selfie poster, people (aka your loyal Instagram audience) are more likely to view you as unlikable, unsuccessful, insecure, and closed off to new experiences.
The study was born from the idea that chronic selfie takers are more narcissistic than the rest of us. Chris Barry, PhD, the lead author of this study, conducted research into that hypothesis and found inconclusive results: Selfie prevalence just wasn’t indicative of personality. However, Dr. Barry realized there may be a stronger link between the amount of selfies posted and how people (whom the selfies are forced upon) perceive the selfie taker. [Editor’s note: I am more tired of reading the word “selfie” than of seeing them at this point.]
Study participants were asked to rate the Instagram profiles of 30 undergrad students on attributes such as low self-esteem, self-absorption, and success. The profiles with more posed photos were viewed as being more adventurous, more outgoing, and having high self-esteem, while the reverse was true for profiles with lots of selfies. And for the men trying online dating: Flexing-in-the-mirror selfies were viewed extra negatively.
So what have we learned from this all-important selfie study? If you want to step up your online profile, start by deleting a few of those selfies. Send them to Grandma instead, who will really appreciate your pretty face.
Emoji emotion
You’re setting up your online dating profile. You’ve removed all the selfies and have only the most flattering posed photos of yourself: with your dog, climbing a mountain, at the beach, all the greatest hits. You’ve been messaging the ladies nonstop, impressing them with your witty wordplay and impeccable spelling. But so far, not much is happening. What gives? According to a study from the Kinsey Institute, you’ve got to use more emojis.
Surveying more than 5,000 adults, researchers found that frequent emoji use predicted more first dates and more frequent sexual activity. The findings suggest that
Is an emoji worth a thousand words? For some, apparently. The authors noted that emojis can be used in addition to words to strategically infuse digital communication with expression and emotion that typed words often lack. For many, a smiley emoji carries more emotional weight than writing that you’re happy. If you’re looking to spice up your love life, say it with emojis instead. And if you’re not well-versed in emoji speak, make sure to look up the meaning of the eggplant emoji before you use it.
The nomination would have been enough, really
We here at LOTME love a good survey ... Okay, most of us here at LOTME love a good survey ... All right, it looks like three out of four LOTME staffers surveyed are quite fond of a good survey.
Here, now, finally, is some news about a survey. The good folks at Crestline – whose custom-imprinted promotional products “bring your logo to life!” – asked 1,630 U.S. residents about “America’s Most Memorable Mascots.” The respondents were asked to identify and rate 82 characters representing the best of American marketing, including Colonel Sanders, Little Debbie, Chuck E. Cheese, and the Aflac duck.
In a sweep of epic proportions, the top ranking in each of five measures – least likable, least persuasive, least trustworthy, most annoying, and most creepy – went to the same character: Mr. Mucus, the face of the Mucinex brand.
After hearing the big news, Elyse Altabet, marketing director for Mucinex, had this to say to FiercePharma: “We agree that Mr. Mucus is thoroughly annoying – after all, he is the personification of your most annoying cold. Far from being our mascot, though, it is our sole goal to help get rid of him whenever he tries to invade our lives. Which is why every American knows that when sick happens, we reach for Mucinex.”
Not so sexy after all
Another day, another organism being marketed as an aphrodisiac thanks to some dubious science, according to a report from the New Zealand Newsroom. To be fair, though, advertising a product called sexy pavement lichen as a natural male enhancement isn’t the worst-sounding idea in the world.
The sexy lichen in question, Xanthoparmelia scabrosa, most commonly found in Australia and New Zealand, isn’t that much more attractive than any other lichen. It’s more of a nuisance than anything else, as it loves to grow in pavement and makes roads covered in the stuff dangerously slick when it rains.
As for any benefit as an aphrodisiac, the plant does contain a PDE5 inhibitor, which can inhibit an enzyme causing impotence but may also be toxic on its own. Plus you’ll be getting a dose of such heavy metals as copper, lead, cadmium, mercury, and basically anything else you’d find in asphalt.
The “legitimate” business people involved claim to grind up the actual lichen, and their product is then marketed as an ancient Chinese therapy for erectile dysfunction. A thriving market has been built around sexy pavement lichen, with thousands of tons available on websites such as Alibaba at the premium price of $100 per kg.
In reality, people are buying a combination of Viagra and grass clippings, as harvesting that much lichen would be both unfeasible and unsustainable, according to the Newsroom report. Sadly, it seems that “legitimate” business people have once again let us all down. But hey, at least they’re not selling poisonous lichen.
Dapagliflozin meets primary endpoint in the DAPA-HF trial
The SGLT2 inhibitor dapagliflozin (Farxiga) successfully met the primary endpoint of the phase 3 DAPA-HF trial in patients with heart failure, according to a press release from AstraZeneca.
DAPA-HF is an international, multicenter, parallel group, randomized, double-blind trial in patients with heart failure and reduced ejection fraction with or without type 2 diabetes. Patients in the study received either 10 mg dapagliflozin or placebo, and the primary outcome was time to a worsening heart failure event or to cardiovascular death. Patients who received dapagliflozin had a statistically significant reduction in incidence of cardiovascular death and an increase in time to a heart failure event.
The adverse events reported for dapagliflozin in DAPA-HF matched the established safety profile for the drug, AstraZeneca noted in the press release.
“The benefits of dapagliflozin in DAPA-HF are very impressive, with a substantial reduction in the primary composite outcome of cardiovascular death or hospital admission. We hope these exciting new findings will ultimately help reduce the terrible burden of disease caused by heart failure and help improve outcomes for our patients,” said John McMurray, MD, of the Institute of Cardiovascular and Medical Sciences at the University of Glasgow.
Another dapagliflozin trial, called DELIVER, is focused on 4,700 patients with heart failure with preserved ejection fraction randomized to dapagliflozin (Farxiga) or placebo. That is due to be completed next year.
The full results from DAPA-HF will be presented at a later date.
The SGLT2 inhibitor dapagliflozin (Farxiga) successfully met the primary endpoint of the phase 3 DAPA-HF trial in patients with heart failure, according to a press release from AstraZeneca.
DAPA-HF is an international, multicenter, parallel group, randomized, double-blind trial in patients with heart failure and reduced ejection fraction with or without type 2 diabetes. Patients in the study received either 10 mg dapagliflozin or placebo, and the primary outcome was time to a worsening heart failure event or to cardiovascular death. Patients who received dapagliflozin had a statistically significant reduction in incidence of cardiovascular death and an increase in time to a heart failure event.
The adverse events reported for dapagliflozin in DAPA-HF matched the established safety profile for the drug, AstraZeneca noted in the press release.
“The benefits of dapagliflozin in DAPA-HF are very impressive, with a substantial reduction in the primary composite outcome of cardiovascular death or hospital admission. We hope these exciting new findings will ultimately help reduce the terrible burden of disease caused by heart failure and help improve outcomes for our patients,” said John McMurray, MD, of the Institute of Cardiovascular and Medical Sciences at the University of Glasgow.
Another dapagliflozin trial, called DELIVER, is focused on 4,700 patients with heart failure with preserved ejection fraction randomized to dapagliflozin (Farxiga) or placebo. That is due to be completed next year.
The full results from DAPA-HF will be presented at a later date.
The SGLT2 inhibitor dapagliflozin (Farxiga) successfully met the primary endpoint of the phase 3 DAPA-HF trial in patients with heart failure, according to a press release from AstraZeneca.
DAPA-HF is an international, multicenter, parallel group, randomized, double-blind trial in patients with heart failure and reduced ejection fraction with or without type 2 diabetes. Patients in the study received either 10 mg dapagliflozin or placebo, and the primary outcome was time to a worsening heart failure event or to cardiovascular death. Patients who received dapagliflozin had a statistically significant reduction in incidence of cardiovascular death and an increase in time to a heart failure event.
The adverse events reported for dapagliflozin in DAPA-HF matched the established safety profile for the drug, AstraZeneca noted in the press release.
“The benefits of dapagliflozin in DAPA-HF are very impressive, with a substantial reduction in the primary composite outcome of cardiovascular death or hospital admission. We hope these exciting new findings will ultimately help reduce the terrible burden of disease caused by heart failure and help improve outcomes for our patients,” said John McMurray, MD, of the Institute of Cardiovascular and Medical Sciences at the University of Glasgow.
Another dapagliflozin trial, called DELIVER, is focused on 4,700 patients with heart failure with preserved ejection fraction randomized to dapagliflozin (Farxiga) or placebo. That is due to be completed next year.
The full results from DAPA-HF will be presented at a later date.
FDA approves lefamulin for community-acquired bacterial pneumonia treatment
The Food and Drug Administration has announced its approval of lefamulin (Xenleta) for the treatment of community-acquired bacterial pneumonia in adults.
Approval was based on results of two clinical trials assessing a total of 1,289 people with community-acquired bacterial pneumonia. In these trials, lefamulin was compared with moxifloxacin with and without linezolid. Patients who received lefamulin had similar rates of treatment success as those taking moxifloxacin alone or moxifloxacin plus linezolid.
The most common adverse reactions associated with lefamulin include diarrhea, nausea, reactions at the injection site, elevated liver enzymes, and vomiting. Patients with prolonged QT interval, patients with arrhythmias, patients receiving treatment with antiarrhythmic agents, and patients receiving other drugs that prolong the QT interval are contraindicated. In addition, because of evidence of fetal harm in animal studies, pregnant women should be advised of potential risks before receiving lefamulin.
“This new drug provides another option for the treatment of patients with community-acquired bacterial pneumonia, a serious disease. For managing this serious disease, it is important for physicians and patients to have treatment options,” Ed Cox, MD, MPH, director of the FDA’s Office of Antimicrobial Products, said in the press release.
The Food and Drug Administration has announced its approval of lefamulin (Xenleta) for the treatment of community-acquired bacterial pneumonia in adults.
Approval was based on results of two clinical trials assessing a total of 1,289 people with community-acquired bacterial pneumonia. In these trials, lefamulin was compared with moxifloxacin with and without linezolid. Patients who received lefamulin had similar rates of treatment success as those taking moxifloxacin alone or moxifloxacin plus linezolid.
The most common adverse reactions associated with lefamulin include diarrhea, nausea, reactions at the injection site, elevated liver enzymes, and vomiting. Patients with prolonged QT interval, patients with arrhythmias, patients receiving treatment with antiarrhythmic agents, and patients receiving other drugs that prolong the QT interval are contraindicated. In addition, because of evidence of fetal harm in animal studies, pregnant women should be advised of potential risks before receiving lefamulin.
“This new drug provides another option for the treatment of patients with community-acquired bacterial pneumonia, a serious disease. For managing this serious disease, it is important for physicians and patients to have treatment options,” Ed Cox, MD, MPH, director of the FDA’s Office of Antimicrobial Products, said in the press release.
The Food and Drug Administration has announced its approval of lefamulin (Xenleta) for the treatment of community-acquired bacterial pneumonia in adults.
Approval was based on results of two clinical trials assessing a total of 1,289 people with community-acquired bacterial pneumonia. In these trials, lefamulin was compared with moxifloxacin with and without linezolid. Patients who received lefamulin had similar rates of treatment success as those taking moxifloxacin alone or moxifloxacin plus linezolid.
The most common adverse reactions associated with lefamulin include diarrhea, nausea, reactions at the injection site, elevated liver enzymes, and vomiting. Patients with prolonged QT interval, patients with arrhythmias, patients receiving treatment with antiarrhythmic agents, and patients receiving other drugs that prolong the QT interval are contraindicated. In addition, because of evidence of fetal harm in animal studies, pregnant women should be advised of potential risks before receiving lefamulin.
“This new drug provides another option for the treatment of patients with community-acquired bacterial pneumonia, a serious disease. For managing this serious disease, it is important for physicians and patients to have treatment options,” Ed Cox, MD, MPH, director of the FDA’s Office of Antimicrobial Products, said in the press release.
FDA approves Xenleta for community-acquired bacterial pneumonia treatment
The Food and Drug Administration has announced its approval of lefamulin (Xenleta) for the treatment of community-acquired bacterial pneumonia in adults.
Approval was based on results of two clinical trials assessing a total of 1,289 people with community-acquired bacterial pneumonia. In these trials, lefamulin was compared with moxifloxacin with and without linezolid. Patients who received lefamulin had similar rates of treatment success as those taking moxifloxacin alone or moxifloxacin plus linezolid.
The most common adverse reactions associated with lefamulin include diarrhea, nausea, reactions at the injection site, elevated liver enzymes, and vomiting. Patients with prolonged QT interval, patients with arrhythmias, patients receiving treatment with antiarrhythmic agents, and patients receiving other drugs that prolong the QT interval are contraindicated. In addition, because of evidence of fetal harm in animal studies, pregnant women should be advised of potential risks before receiving lefamulin.
“This new drug provides another option for the treatment of patients with community-acquired bacterial pneumonia, a serious disease. For managing this serious disease, it is important for physicians and patients to have treatment options,” Ed Cox, MD, MPH, director of the FDA’s Office of Antimicrobial Products, said in the press release.
The Food and Drug Administration has announced its approval of lefamulin (Xenleta) for the treatment of community-acquired bacterial pneumonia in adults.
Approval was based on results of two clinical trials assessing a total of 1,289 people with community-acquired bacterial pneumonia. In these trials, lefamulin was compared with moxifloxacin with and without linezolid. Patients who received lefamulin had similar rates of treatment success as those taking moxifloxacin alone or moxifloxacin plus linezolid.
The most common adverse reactions associated with lefamulin include diarrhea, nausea, reactions at the injection site, elevated liver enzymes, and vomiting. Patients with prolonged QT interval, patients with arrhythmias, patients receiving treatment with antiarrhythmic agents, and patients receiving other drugs that prolong the QT interval are contraindicated. In addition, because of evidence of fetal harm in animal studies, pregnant women should be advised of potential risks before receiving lefamulin.
“This new drug provides another option for the treatment of patients with community-acquired bacterial pneumonia, a serious disease. For managing this serious disease, it is important for physicians and patients to have treatment options,” Ed Cox, MD, MPH, director of the FDA’s Office of Antimicrobial Products, said in the press release.
The Food and Drug Administration has announced its approval of lefamulin (Xenleta) for the treatment of community-acquired bacterial pneumonia in adults.
Approval was based on results of two clinical trials assessing a total of 1,289 people with community-acquired bacterial pneumonia. In these trials, lefamulin was compared with moxifloxacin with and without linezolid. Patients who received lefamulin had similar rates of treatment success as those taking moxifloxacin alone or moxifloxacin plus linezolid.
The most common adverse reactions associated with lefamulin include diarrhea, nausea, reactions at the injection site, elevated liver enzymes, and vomiting. Patients with prolonged QT interval, patients with arrhythmias, patients receiving treatment with antiarrhythmic agents, and patients receiving other drugs that prolong the QT interval are contraindicated. In addition, because of evidence of fetal harm in animal studies, pregnant women should be advised of potential risks before receiving lefamulin.
“This new drug provides another option for the treatment of patients with community-acquired bacterial pneumonia, a serious disease. For managing this serious disease, it is important for physicians and patients to have treatment options,” Ed Cox, MD, MPH, director of the FDA’s Office of Antimicrobial Products, said in the press release.
Short-term parenteral antibiotics effective for bacteremic UTI in young infants
according to a study.
While previous studies have shown short-term parenteral antibiotic therapy to be safe and equally effective in uncomplicated urinary tract infections (UTIs), short-term therapy safety in bacteremic UTI had not been established, Sanyukta Desai, MD, of the University of Cincinnati and Cincinnati Children’s Hospital and associates wrote in Pediatrics.
“As a result, infants with bacteremic UTI often receive prolonged courses of parenteral antibiotics, which can lead to long hospitalizations and increased costs,” they said.
In a multicenter, retrospective cohort study, Dr. Desai and associates analyzed a group of 115 infants aged 60 days or younger who were admitted to a group of 11 participating EDs between July 1, 2011, and June 30, 2016, if they had a UTI caused by a bacterial pathogen. Half of the infants were administered parenteral antibiotics for 7 days or less before being switched to oral antibiotics, and the rest were given parenteral antibiotics for more than 7 days before switching to oral. Infants were more likely to receive long-term parenteral treatment if they were ill appearing and had growth of a non–Escherichia coli organism.
Six infants (two in the short-term group, four in the long-term group) had a recurrent UTI, each one diagnosed between 15 and 30 days after discharge; the adjusted risk difference between the two groups was 3% (95% confidence interval, –5.8 to 12.7). Two of the infants in the long-term group with a recurrent UTI had a different organism than during the index infection. When comparing only the infants with growth of the same pathogen that caused the index UTI, the adjusted risk difference between the two groups was 0.2% (95% CI, –7.8 to 8.3).
A total of 15 infants (6 in the short-term group, 9 in the long-term group) had 30-day all-cause reutilization, with no significant difference between groups (adjusted risk difference, 3%; 95% CI, –14.6 to 20.4).
Mean length of stay was significantly longer in the long-term treatment group, compared with the short-term group (11 days vs. 5 days; adjusted mean difference, 6 days; 95% CI, 4.0-8.8).
No infants experienced a serious adverse event such as ICU readmission, need for mechanical ventilation or vasopressor use, or signs of neurologic sequelae within 30 days of discharge from the index hospitalization, the investigators noted. Peripherally inserted central catheters were required in 13 infants; of these, 1 infant had to revisit an ED because of a related mechanical complication.
“Researchers in future prospective studies should seek to establish the bioavailability and optimal dosing of oral antibiotics in young infants and assess if there are particular subpopulations of infants with bacteremic UTI who may benefit from longer courses of parenteral antibiotic therapy,” Dr. Desai and associates concluded.
In a related editorial, Natalia V. Leva, MD, and Hillary L. Copp, MD, of the University of California, San Francisco, noted that the study represents a “critical piece of a complicated puzzle that not only includes minimum duration of parenteral antibiotic treatment but also involves bioavailability of antimicrobial agents in infants and total treatment duration, which includes parenteral and oral antibiotic therapy.”
The question that remains is how long a duration of parenteral antibiotic is necessary, Dr. Leva and Dr. Copp wrote. “Desai et al. used a relatively arbitrary cutoff of 7 days on the basis of the distribution of antibiotic course among their patient population; however, this is likely more a reflection of clinical practice than it is evidence based.” They concluded that this study provided evidence that a “short course of parenteral antibiotics in infants [aged 60 days or younger] with bacteremic UTI is safe and effective. Although the current study does not address total duration of antibiotics [parenteral and oral], it does shine a light on where we should focus future research endeavors.”
The study authors reported that they had no conflicts of interest. The study was supported in part by a National Center for Advancing Translational Sciences grant and an Agency for Healthcare Research and Quality grant. The editorialists had no relevant conflicts of interest and received no external funding.
SOURCEs: Desai S et al. Pediatrics. 2019 Aug 20. doi: 10.1542/peds.2018-3844; Leva et al. 2019 Aug 20. doi: 10.1542/peds.2019-1611.
according to a study.
While previous studies have shown short-term parenteral antibiotic therapy to be safe and equally effective in uncomplicated urinary tract infections (UTIs), short-term therapy safety in bacteremic UTI had not been established, Sanyukta Desai, MD, of the University of Cincinnati and Cincinnati Children’s Hospital and associates wrote in Pediatrics.
“As a result, infants with bacteremic UTI often receive prolonged courses of parenteral antibiotics, which can lead to long hospitalizations and increased costs,” they said.
In a multicenter, retrospective cohort study, Dr. Desai and associates analyzed a group of 115 infants aged 60 days or younger who were admitted to a group of 11 participating EDs between July 1, 2011, and June 30, 2016, if they had a UTI caused by a bacterial pathogen. Half of the infants were administered parenteral antibiotics for 7 days or less before being switched to oral antibiotics, and the rest were given parenteral antibiotics for more than 7 days before switching to oral. Infants were more likely to receive long-term parenteral treatment if they were ill appearing and had growth of a non–Escherichia coli organism.
Six infants (two in the short-term group, four in the long-term group) had a recurrent UTI, each one diagnosed between 15 and 30 days after discharge; the adjusted risk difference between the two groups was 3% (95% confidence interval, –5.8 to 12.7). Two of the infants in the long-term group with a recurrent UTI had a different organism than during the index infection. When comparing only the infants with growth of the same pathogen that caused the index UTI, the adjusted risk difference between the two groups was 0.2% (95% CI, –7.8 to 8.3).
A total of 15 infants (6 in the short-term group, 9 in the long-term group) had 30-day all-cause reutilization, with no significant difference between groups (adjusted risk difference, 3%; 95% CI, –14.6 to 20.4).
Mean length of stay was significantly longer in the long-term treatment group, compared with the short-term group (11 days vs. 5 days; adjusted mean difference, 6 days; 95% CI, 4.0-8.8).
No infants experienced a serious adverse event such as ICU readmission, need for mechanical ventilation or vasopressor use, or signs of neurologic sequelae within 30 days of discharge from the index hospitalization, the investigators noted. Peripherally inserted central catheters were required in 13 infants; of these, 1 infant had to revisit an ED because of a related mechanical complication.
“Researchers in future prospective studies should seek to establish the bioavailability and optimal dosing of oral antibiotics in young infants and assess if there are particular subpopulations of infants with bacteremic UTI who may benefit from longer courses of parenteral antibiotic therapy,” Dr. Desai and associates concluded.
In a related editorial, Natalia V. Leva, MD, and Hillary L. Copp, MD, of the University of California, San Francisco, noted that the study represents a “critical piece of a complicated puzzle that not only includes minimum duration of parenteral antibiotic treatment but also involves bioavailability of antimicrobial agents in infants and total treatment duration, which includes parenteral and oral antibiotic therapy.”
The question that remains is how long a duration of parenteral antibiotic is necessary, Dr. Leva and Dr. Copp wrote. “Desai et al. used a relatively arbitrary cutoff of 7 days on the basis of the distribution of antibiotic course among their patient population; however, this is likely more a reflection of clinical practice than it is evidence based.” They concluded that this study provided evidence that a “short course of parenteral antibiotics in infants [aged 60 days or younger] with bacteremic UTI is safe and effective. Although the current study does not address total duration of antibiotics [parenteral and oral], it does shine a light on where we should focus future research endeavors.”
The study authors reported that they had no conflicts of interest. The study was supported in part by a National Center for Advancing Translational Sciences grant and an Agency for Healthcare Research and Quality grant. The editorialists had no relevant conflicts of interest and received no external funding.
SOURCEs: Desai S et al. Pediatrics. 2019 Aug 20. doi: 10.1542/peds.2018-3844; Leva et al. 2019 Aug 20. doi: 10.1542/peds.2019-1611.
according to a study.
While previous studies have shown short-term parenteral antibiotic therapy to be safe and equally effective in uncomplicated urinary tract infections (UTIs), short-term therapy safety in bacteremic UTI had not been established, Sanyukta Desai, MD, of the University of Cincinnati and Cincinnati Children’s Hospital and associates wrote in Pediatrics.
“As a result, infants with bacteremic UTI often receive prolonged courses of parenteral antibiotics, which can lead to long hospitalizations and increased costs,” they said.
In a multicenter, retrospective cohort study, Dr. Desai and associates analyzed a group of 115 infants aged 60 days or younger who were admitted to a group of 11 participating EDs between July 1, 2011, and June 30, 2016, if they had a UTI caused by a bacterial pathogen. Half of the infants were administered parenteral antibiotics for 7 days or less before being switched to oral antibiotics, and the rest were given parenteral antibiotics for more than 7 days before switching to oral. Infants were more likely to receive long-term parenteral treatment if they were ill appearing and had growth of a non–Escherichia coli organism.
Six infants (two in the short-term group, four in the long-term group) had a recurrent UTI, each one diagnosed between 15 and 30 days after discharge; the adjusted risk difference between the two groups was 3% (95% confidence interval, –5.8 to 12.7). Two of the infants in the long-term group with a recurrent UTI had a different organism than during the index infection. When comparing only the infants with growth of the same pathogen that caused the index UTI, the adjusted risk difference between the two groups was 0.2% (95% CI, –7.8 to 8.3).
A total of 15 infants (6 in the short-term group, 9 in the long-term group) had 30-day all-cause reutilization, with no significant difference between groups (adjusted risk difference, 3%; 95% CI, –14.6 to 20.4).
Mean length of stay was significantly longer in the long-term treatment group, compared with the short-term group (11 days vs. 5 days; adjusted mean difference, 6 days; 95% CI, 4.0-8.8).
No infants experienced a serious adverse event such as ICU readmission, need for mechanical ventilation or vasopressor use, or signs of neurologic sequelae within 30 days of discharge from the index hospitalization, the investigators noted. Peripherally inserted central catheters were required in 13 infants; of these, 1 infant had to revisit an ED because of a related mechanical complication.
“Researchers in future prospective studies should seek to establish the bioavailability and optimal dosing of oral antibiotics in young infants and assess if there are particular subpopulations of infants with bacteremic UTI who may benefit from longer courses of parenteral antibiotic therapy,” Dr. Desai and associates concluded.
In a related editorial, Natalia V. Leva, MD, and Hillary L. Copp, MD, of the University of California, San Francisco, noted that the study represents a “critical piece of a complicated puzzle that not only includes minimum duration of parenteral antibiotic treatment but also involves bioavailability of antimicrobial agents in infants and total treatment duration, which includes parenteral and oral antibiotic therapy.”
The question that remains is how long a duration of parenteral antibiotic is necessary, Dr. Leva and Dr. Copp wrote. “Desai et al. used a relatively arbitrary cutoff of 7 days on the basis of the distribution of antibiotic course among their patient population; however, this is likely more a reflection of clinical practice than it is evidence based.” They concluded that this study provided evidence that a “short course of parenteral antibiotics in infants [aged 60 days or younger] with bacteremic UTI is safe and effective. Although the current study does not address total duration of antibiotics [parenteral and oral], it does shine a light on where we should focus future research endeavors.”
The study authors reported that they had no conflicts of interest. The study was supported in part by a National Center for Advancing Translational Sciences grant and an Agency for Healthcare Research and Quality grant. The editorialists had no relevant conflicts of interest and received no external funding.
SOURCEs: Desai S et al. Pediatrics. 2019 Aug 20. doi: 10.1542/peds.2018-3844; Leva et al. 2019 Aug 20. doi: 10.1542/peds.2019-1611.
FROM PEDIATRICS
Key clinical point: Urinary tract infection (UTI) recurrence and hospital reutilization was similar in infants with bacteremic UTIs, regardless of parenteral antibiotic treatment duration of 7 days or less or greater than 7 days prior to oral antibiotics.
Major finding: The adjusted risk difference for both infection recurrence and hospital reutilization was 3% and was nonsignificant in both cases.
Study details: A group of 115 infants aged 60 days or younger who were admitted to an ED with a bacteremic UTI.
Disclosures: The study authors reported that they had no conflicts of interest. The funding of the study was supported in part by a National Center for Advancing Translational Sciences grant and an Agency for Healthcare Research and Quality grant.
Source: Desai S et al. Pediatrics. 2019 Aug 20. doi: 10.1542/peds.2018-3844.
TAVR valves now FDA approved for low-risk patients
The Food and Drug Administration has expanded the indication for the Sapien 3, Sapien 3 Ultra, CoreValve Evolut R, and CoreValve Evolut PRO transcatheter heart valves to include patients with severe aortic valve stenosis at low risk for death or major complications associated with open-heart surgery.
The announcement was based on results of a pair of clinical trials involving patients with severe aortic valve stenosis. In the first, 1,000 patients were randomly sorted to receive either transcatheter aortic valve replacement (TAVR) with the Edwards Lifescience’s Sapien 3 device or open-heart surgery. In the second, 1,468 patients received either Medtronic’s CoreValve Evolut R or CoreValve Evolut PRO or open heart surgery. In both studies, after an average follow-up time of 15-17 months, outcomes such as all-cause mortality and stroke were similar in patients who underwent open heart surgery and who received the transcatheter heart valve.
Serious adverse events associated with transcatheter heart valves include death, stroke, acute kidney injury, heart attack, bleeding, and the need for a permanent pacemaker. Patients who cannot tolerate blood-thinning medication or have an infection in the heart are contraindicated; in addition, the CoreValve devices should not be used in patients sensitive to titanium or nickel. Because the longevity of transcatheter heart valves, compared with open-heart surgery, has not been established, younger patients should discuss options with their health care provider.
“This new approval significantly expands the number of patients that can be treated with this less invasive procedure for aortic valve replacement and follows a thorough review of data demonstrating these devices are safe and effective for this larger population,” Bram Zuckerman, MD, director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health, said in the press release.
Find the full press release on the FDA website.
The Food and Drug Administration has expanded the indication for the Sapien 3, Sapien 3 Ultra, CoreValve Evolut R, and CoreValve Evolut PRO transcatheter heart valves to include patients with severe aortic valve stenosis at low risk for death or major complications associated with open-heart surgery.
The announcement was based on results of a pair of clinical trials involving patients with severe aortic valve stenosis. In the first, 1,000 patients were randomly sorted to receive either transcatheter aortic valve replacement (TAVR) with the Edwards Lifescience’s Sapien 3 device or open-heart surgery. In the second, 1,468 patients received either Medtronic’s CoreValve Evolut R or CoreValve Evolut PRO or open heart surgery. In both studies, after an average follow-up time of 15-17 months, outcomes such as all-cause mortality and stroke were similar in patients who underwent open heart surgery and who received the transcatheter heart valve.
Serious adverse events associated with transcatheter heart valves include death, stroke, acute kidney injury, heart attack, bleeding, and the need for a permanent pacemaker. Patients who cannot tolerate blood-thinning medication or have an infection in the heart are contraindicated; in addition, the CoreValve devices should not be used in patients sensitive to titanium or nickel. Because the longevity of transcatheter heart valves, compared with open-heart surgery, has not been established, younger patients should discuss options with their health care provider.
“This new approval significantly expands the number of patients that can be treated with this less invasive procedure for aortic valve replacement and follows a thorough review of data demonstrating these devices are safe and effective for this larger population,” Bram Zuckerman, MD, director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health, said in the press release.
Find the full press release on the FDA website.
The Food and Drug Administration has expanded the indication for the Sapien 3, Sapien 3 Ultra, CoreValve Evolut R, and CoreValve Evolut PRO transcatheter heart valves to include patients with severe aortic valve stenosis at low risk for death or major complications associated with open-heart surgery.
The announcement was based on results of a pair of clinical trials involving patients with severe aortic valve stenosis. In the first, 1,000 patients were randomly sorted to receive either transcatheter aortic valve replacement (TAVR) with the Edwards Lifescience’s Sapien 3 device or open-heart surgery. In the second, 1,468 patients received either Medtronic’s CoreValve Evolut R or CoreValve Evolut PRO or open heart surgery. In both studies, after an average follow-up time of 15-17 months, outcomes such as all-cause mortality and stroke were similar in patients who underwent open heart surgery and who received the transcatheter heart valve.
Serious adverse events associated with transcatheter heart valves include death, stroke, acute kidney injury, heart attack, bleeding, and the need for a permanent pacemaker. Patients who cannot tolerate blood-thinning medication or have an infection in the heart are contraindicated; in addition, the CoreValve devices should not be used in patients sensitive to titanium or nickel. Because the longevity of transcatheter heart valves, compared with open-heart surgery, has not been established, younger patients should discuss options with their health care provider.
“This new approval significantly expands the number of patients that can be treated with this less invasive procedure for aortic valve replacement and follows a thorough review of data demonstrating these devices are safe and effective for this larger population,” Bram Zuckerman, MD, director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health, said in the press release.
Find the full press release on the FDA website.