There are several scheduled PDFUA dates for the U.S. Food and Drug Administration (FDA) over the next two weeks. Here’s a look.
Flexion’s Zilretta for Osteoporosis of the Knee
Flexion Therapeutics has a target action date of October 14 for its supplemental NDA to revise the label for Zilretta to allow for repeat administration. This sNDA was based
on an open-label Phase IIIb clinical trial of Zilretta in patients with
osteoarthritis (OA) of the knee. It showed that repeat dosing of the
drug for OA knee pain was generally safe and well-tolerated with no
deleterious impact on cartilage or joint structure as seen on x-rays.
The trial also found that the amount and duration of pain relief was
similar in the first and second injections.
Zilretta launched in the fourth quarter of 2017. It is the first and
only extended-release, intra-articular therapy for OA-related knee pain.
It uses the company’s proprietary microsphere technology combined with
triamcinolone acetonide, a common short-acting corticosteroid with a
poly lactic-co-glycolic acid (PLGA) matrix that provides extended pain
relief.
Alexion Pharmaceuticals’ Ultomiris for aHUS
Alexion Pharmaceuticals has a target action date
of October 19 for its supplemental Biologics License Application (sBLA)
for Ultomiris (ravulizumab-cwvz) for the treatment of atypical
hemolytic uremic syndrome (aHUS) in order to inhibit complement-mediated
thrombotic microangiopathy (TMA). aHUS is a severe and chronic
ultra-rare disease that can cause progressive damage to the organs,
primarily the kidneys, which can lead to kidney failure and premature
death.
Ultomiris is approved to treat adults with Paroxysmal Nocturnal Hemoglobinuria (PNH).
The sBLA is based on data
from the Phase III trial of the drug announced in January 2019. In the
first 26-week treatment period, 53.6% of patients showed complete
thrombotic microangiopathy (TMA) response. The primary endpoint of
complete TMA response was defined by hematologic normalization and
improved kidney function.
The sBLA is being evaluated under Priority Review.
Clearside Biomedical’s Xipere for Macular Edema
Clearside Biomedical has a target action date
of October 19 for its NDA for Xipere (triamcinolone acetonide
ophthalmic suspension) for Suprachoroidal Injection for macular edema
associated with uveitis. The NDA is based on data from the PEACHTREE
clinical trial that showed significant and clinically meaningful
improvement in eyesight for patients with macular edema associated with
non-infectious uveitis. Uveitis is a group of ocular inflammatory
conditions and one of the leading causes of vision loss. It affects
about 350,000 people in the U.S. and more than a million worldwide.
Macular edema is an accumulation of fluid in the macula, the area of the
retina that accounts for sharp, straight-ahead vision.
However, on August 22, the company received an update
about the NDA from the FDA’s Office of Pharmaceutical Quality (OPQ)
requesting more stability data for the TA suspension that uses an
enhanced manufacturing process. The TA formulation hadn’t changed, but
the OPQ requested data to verify comparability of the stability profiles
from several batches submitted as part of the NDA.
As a result, the company expects to receive a Complete Response
Letter from the FDA on or before October 19. It will then resubmit the
NDA in the first quarter of 2020 with the requested stability data.
“We believe this is primarily a timing issue since our stability data
from previously manufactured batches have been consistent and
predictable, and we have every reason to believe this will continue to
be the case,” stated George Lasezkay, Clearside’s chief executive
officer, in an August statement.
https://www.biospace.com/article/fda-action-alert-pfenex-flexion-alexion-and-clearside/
Monday, October 7, 2019
EU Panel: Don’t Use Estradiol Creams for Longer Than 4 Weeks
The European Medicines Agency’s Pharmacovigilance Risk Assessment
Committee (PRAC) recommends capping the use of high-strength creams that
contain estradiol 100 μg/g (0.01%) at a single treatment period of no longer than 4 weeks.
The reason for this recommendation is to lower the risk for adverse effects, such as blood clots, strokes, and certain types of cancer, which can result from absorption of estradiol into the bloodstream from intravaginal creams used to relieve vaginal atrophy symptoms in postmenopausal women.
The recommendation appears in highlights from the PRAC meeting held from September 30 to October 3.
The European Commission requested the review, which was initiated in April 2019, after a ruling by the European Union Court of Justice that “partially annulled the conclusions of a previous PRAC review of these medicines in 2014 on procedural grounds.”
The Court of Justice accepted the scientific conclusions; however, this partial annulment invalidated some of the measures implemented to reduce the risk.
The PRAC’s recommendation follows consideration of all available safety and efficacy data on high-strength estradiol-containing creams, including the amount of the hormone in the blood.
“These data showed that in postmenopausal women who had used these creams, the levels of estradiol in the blood were higher than normal postmenopausal levels,” according to the meeting highlights.
The new recommendations will be added to the prescribing information for these estradiol creams, along with a warning that they be used for no more than a single treatment period of no longer as 4 weeks. This warning will be on the outer and inner packaging, and the tube size will be no larger than 25 g to prevent more extended use than recommended.
https://www.medscape.com/viewarticle/919501
The reason for this recommendation is to lower the risk for adverse effects, such as blood clots, strokes, and certain types of cancer, which can result from absorption of estradiol into the bloodstream from intravaginal creams used to relieve vaginal atrophy symptoms in postmenopausal women.
The recommendation appears in highlights from the PRAC meeting held from September 30 to October 3.
The European Commission requested the review, which was initiated in April 2019, after a ruling by the European Union Court of Justice that “partially annulled the conclusions of a previous PRAC review of these medicines in 2014 on procedural grounds.”
The Court of Justice accepted the scientific conclusions; however, this partial annulment invalidated some of the measures implemented to reduce the risk.
The PRAC’s recommendation follows consideration of all available safety and efficacy data on high-strength estradiol-containing creams, including the amount of the hormone in the blood.
“These data showed that in postmenopausal women who had used these creams, the levels of estradiol in the blood were higher than normal postmenopausal levels,” according to the meeting highlights.
The new recommendations will be added to the prescribing information for these estradiol creams, along with a warning that they be used for no more than a single treatment period of no longer as 4 weeks. This warning will be on the outer and inner packaging, and the tube size will be no larger than 25 g to prevent more extended use than recommended.
https://www.medscape.com/viewarticle/919501
Immunotherapy-Induced Arthritis Persists Post-Cancer Therapy
Target Audience and Goal Statement:
Oncologists, rheumatologists, internists, family medicine specialists
The goal of this study was to determine the long-term outcomes of cancer patients treated with immune checkpoint inhibitors (ICIs) who developed inflammatory arthritis.
Question Addressed:
In cancer patients who developed arthritis during treatment with ICIs, joint symptoms were less likely to resolve in those with greater exposure to these drugs and in those treated with a combination of ICIs, a prospective observational study found.
Patients with a history of other immune-related adverse events also
had more persistent arthritis, according to Laura C. Cappelli, MD, and
colleagues from Johns Hopkins School of Medicine in Baltimore.
In a multivariate analysis, the likelihood of improvement in inflammatory arthritis was lower for patients with longer duration of ICI treatment, with a hazard ratio of 0.82 (95% CI 0.73-0.92, P=0.001), and for those on combination ICI regimens (HR 0.06, 95% CI 0.01-0.50, P=0.009), researchers reported online in Annals of the Rheumatic Diseases.
“This information provides insight into which individuals are at highest risk for developing persistent inflammatory arthritis, thus warranting close monitoring for joint-related symptoms, early referral to and close follow-up by rheumatology, and potentially more aggressive immunosuppressive therapy,” Cappelli’s group wrote.
As ICIs are increasingly used in treating a range of cancer types, researchers have seen the development of a number of inflammatory and autoimmune syndromes in patients during treatment, possibly through activation of T cells against antigens to the self, the researchers said. Some of these adverse events, such as pneumonitis and colitis, can be deadly, while others, such as inflammatory arthritis and thyroid dysfunction, can have profound and ongoing impact on patients’ function and quality of life. There have also been reports of the rapid appearance of erosions in affected patients.
Most patients who develop arthritis have required treatment with corticosteroids, other immunosuppressives, and even biologic agents, but it has been challenging to develop optimal strategies, given the context that their cancer treatment has involved immune activation. In addition, risk factors for the occurrence and persistence of arthritis have so far been unknown.
For this study, the researchers looked at the long-term outcomes of 60 patients who developed arthritis with ICI treatment. The team recruited patients from 2015 to 2018 who had been referred to the Johns Hopkins Arthritis Center and who had been given an anti-CTLA-4, anti-PD-1, or anti-PD-L1 agent, or a combination of these drugs. The average follow-up time was 12 months after stopping the ICI treatment.
Slightly more than half of the participants were women; mean age was 59 and most were white. The median Clinical Disease Activity Index at the time of recruitment was 17.5, which represents moderate activity. Duration of ICI treatment averaged 7 months, and half of patients had reported other immune-related events, most often colitis and rash.
The most common types of cancer treated in this population were melanoma and non-small cell lung cancer, and treatment outcomes included stable disease in 28.3% of patients, progressive disease in 25%, complete response in 23.3%, partial response in 16.7%, and no evidence of disease in 6.7%.
Follow-up data 3 months after cessation of ICI treatment were available for 51 patients, at which time 70.6% still had active arthritis. Among the 41 for whom 6-month data were available, 48.8% had persistent arthritis, and among the 20 patients who continued to have inflammatory arthritis at 6 months, 14 remained symptomatic during additional follow-up.
In a univariate analysis, factors associated with a decreased likelihood of improvements in arthritis were:
Three-quarters of patients were prescribed immunomodulatory treatment for their arthritis: corticosteroids in 48, conventional disease-modifying antirheumatic drugs (DMARDs) in 19, and biologics in 11.
Among the 24 patients who received either DMARDs or biologics, only four (16.7%) experienced cancer progression, which did not differ significantly from the rates of progression in patients not given these drugs (22.2%, OR 0.65, 95% CI 0.17-2.47).
A limitation of the study was the possibility of selection bias, acknowledged the researchers.
Source Reference: Annals of the Rheumatic Diseases 2019; DOI: 10.1136/annrheumdis-2019-216109
Study Highlights and Explanation of Findings:
This study confirms earlier smaller studies that indicated that inflammatory arthritis can remain active for months to years after treatment with ICIs ends. The authors noted that other immune-related adverse events that may occur or reoccur and become chronic after ICI cessation are pneumonitis, colitis, hepatitis, dermatitis, and neuropathy.
Previous studies of other types of immune-related adverse events have suggested that most develop during treatment induction, which does not appear to be the case with arthritis, the researchers said. “The kinetics of ICI-induced inflammatory arthritis development differs from many other immune-related adverse events, and may suggest unique immune pathogenesis for ICI-induced inflammatory arthritis, potentially due to longer exposure to ICI therapy.”
“Delayed initial presentation of [immune-related adverse events], with symptoms starting even after ICI cessation, is a related concept that is being increasingly recognized,” the authors wrote. “Further prospective cohort studies are needed to determine which [immune-related adverse events] besides [inflammatory arthritis] are likely to persist or present after ICI cessation.”
They added that the types of immune-related adverse events that persist “may indicate how the immune system interacts with particular target tissue microenvironments causing a feed forward loop of autoimmunity that becomes independent of ICIs.”
The researchers noted that like endocrine-related immune-related adverse events, ICI-induced inflammatory arthritis may need chronic treatment. The cited concern with using immunosuppression to treat these adverse events has been that they may negatively affect antitumor immune responses. Importantly, this study and a number of previous trials indicated that DMARDs and TNF inhibitors used to treat immune-related adverse events do not in fact affect antitumor responses.
Interestingly, the data suggest that patients who develop persistent arthritis may experience better antitumor responses compared with those who have transient arthritis. “Other studies have demonstrated that development of [immune-related adverse events] associates with better progression-free and overall survival, but persistence of an [immune-related adverse event] has not been examined,” the researchers wrote.
Further exploration of the biology of the various types of immune-related adverse events may help in determining more closely targeted therapeutic strategies for these conditions, they noted. “Overall, continued clinical and translational investigation on larger longitudinal cohorts will allow for increased understanding of pathophysiology and determination of the best clinical care for patients with ICI-induced inflammatory arthritis.”
Oncologists, rheumatologists, internists, family medicine specialists
The goal of this study was to determine the long-term outcomes of cancer patients treated with immune checkpoint inhibitors (ICIs) who developed inflammatory arthritis.
Question Addressed:
- What factors were associated with ICI-induced inflammatory arthritis persistence after treatment cessation?
In cancer patients who developed arthritis during treatment with ICIs, joint symptoms were less likely to resolve in those with greater exposure to these drugs and in those treated with a combination of ICIs, a prospective observational study found.
Action Points
- In cancer patients who developed inflammatory arthritis during treatment with immune checkpoint inhibitors (ICIs), joint symptoms were less likely to resolve in those with greater exposure to these drugs, those treated with a combination of ICIs, and those with a history of other immune-related adverse events, according to a prospective observational study.
- Understand that ICI-induced inflammatory arthritis can become a chronic condition in cancer patients, warranting close monitoring for joint-related symptoms, early referral to and close follow-up by rheumatologists, and potentially more aggressive immunosuppressive treatments.
In a multivariate analysis, the likelihood of improvement in inflammatory arthritis was lower for patients with longer duration of ICI treatment, with a hazard ratio of 0.82 (95% CI 0.73-0.92, P=0.001), and for those on combination ICI regimens (HR 0.06, 95% CI 0.01-0.50, P=0.009), researchers reported online in Annals of the Rheumatic Diseases.
“This information provides insight into which individuals are at highest risk for developing persistent inflammatory arthritis, thus warranting close monitoring for joint-related symptoms, early referral to and close follow-up by rheumatology, and potentially more aggressive immunosuppressive therapy,” Cappelli’s group wrote.
As ICIs are increasingly used in treating a range of cancer types, researchers have seen the development of a number of inflammatory and autoimmune syndromes in patients during treatment, possibly through activation of T cells against antigens to the self, the researchers said. Some of these adverse events, such as pneumonitis and colitis, can be deadly, while others, such as inflammatory arthritis and thyroid dysfunction, can have profound and ongoing impact on patients’ function and quality of life. There have also been reports of the rapid appearance of erosions in affected patients.
Most patients who develop arthritis have required treatment with corticosteroids, other immunosuppressives, and even biologic agents, but it has been challenging to develop optimal strategies, given the context that their cancer treatment has involved immune activation. In addition, risk factors for the occurrence and persistence of arthritis have so far been unknown.
For this study, the researchers looked at the long-term outcomes of 60 patients who developed arthritis with ICI treatment. The team recruited patients from 2015 to 2018 who had been referred to the Johns Hopkins Arthritis Center and who had been given an anti-CTLA-4, anti-PD-1, or anti-PD-L1 agent, or a combination of these drugs. The average follow-up time was 12 months after stopping the ICI treatment.
Slightly more than half of the participants were women; mean age was 59 and most were white. The median Clinical Disease Activity Index at the time of recruitment was 17.5, which represents moderate activity. Duration of ICI treatment averaged 7 months, and half of patients had reported other immune-related events, most often colitis and rash.
The most common types of cancer treated in this population were melanoma and non-small cell lung cancer, and treatment outcomes included stable disease in 28.3% of patients, progressive disease in 25%, complete response in 23.3%, partial response in 16.7%, and no evidence of disease in 6.7%.
Follow-up data 3 months after cessation of ICI treatment were available for 51 patients, at which time 70.6% still had active arthritis. Among the 41 for whom 6-month data were available, 48.8% had persistent arthritis, and among the 20 patients who continued to have inflammatory arthritis at 6 months, 14 remained symptomatic during additional follow-up.
In a univariate analysis, factors associated with a decreased likelihood of improvements in arthritis were:
- Longer duration of ICI treatment: HR 0.93 (95% CI 0.87-0.99, P=0.02)
- Combination therapy: HR 0.29 (95% CI 0.12-0.72, P=0.008)
- History of other immune-related events: HR 0.61 (95% CI 0.39-0.95, P=0.03)
Three-quarters of patients were prescribed immunomodulatory treatment for their arthritis: corticosteroids in 48, conventional disease-modifying antirheumatic drugs (DMARDs) in 19, and biologics in 11.
Among the 24 patients who received either DMARDs or biologics, only four (16.7%) experienced cancer progression, which did not differ significantly from the rates of progression in patients not given these drugs (22.2%, OR 0.65, 95% CI 0.17-2.47).
A limitation of the study was the possibility of selection bias, acknowledged the researchers.
Source Reference: Annals of the Rheumatic Diseases 2019; DOI: 10.1136/annrheumdis-2019-216109
Study Highlights and Explanation of Findings:
This study confirms earlier smaller studies that indicated that inflammatory arthritis can remain active for months to years after treatment with ICIs ends. The authors noted that other immune-related adverse events that may occur or reoccur and become chronic after ICI cessation are pneumonitis, colitis, hepatitis, dermatitis, and neuropathy.
Previous studies of other types of immune-related adverse events have suggested that most develop during treatment induction, which does not appear to be the case with arthritis, the researchers said. “The kinetics of ICI-induced inflammatory arthritis development differs from many other immune-related adverse events, and may suggest unique immune pathogenesis for ICI-induced inflammatory arthritis, potentially due to longer exposure to ICI therapy.”
“Delayed initial presentation of [immune-related adverse events], with symptoms starting even after ICI cessation, is a related concept that is being increasingly recognized,” the authors wrote. “Further prospective cohort studies are needed to determine which [immune-related adverse events] besides [inflammatory arthritis] are likely to persist or present after ICI cessation.”
They added that the types of immune-related adverse events that persist “may indicate how the immune system interacts with particular target tissue microenvironments causing a feed forward loop of autoimmunity that becomes independent of ICIs.”
The researchers noted that like endocrine-related immune-related adverse events, ICI-induced inflammatory arthritis may need chronic treatment. The cited concern with using immunosuppression to treat these adverse events has been that they may negatively affect antitumor immune responses. Importantly, this study and a number of previous trials indicated that DMARDs and TNF inhibitors used to treat immune-related adverse events do not in fact affect antitumor responses.
Interestingly, the data suggest that patients who develop persistent arthritis may experience better antitumor responses compared with those who have transient arthritis. “Other studies have demonstrated that development of [immune-related adverse events] associates with better progression-free and overall survival, but persistence of an [immune-related adverse event] has not been examined,” the researchers wrote.
Further exploration of the biology of the various types of immune-related adverse events may help in determining more closely targeted therapeutic strategies for these conditions, they noted. “Overall, continued clinical and translational investigation on larger longitudinal cohorts will allow for increased understanding of pathophysiology and determination of the best clinical care for patients with ICI-induced inflammatory arthritis.”
Reviewed by Henry A. Solomon, MD, FACP, FACC Clinical Associate Professor, Weill Cornell Medical College
Primary Source
Annals of the Rheumatic Diseases
Secondary Source
MedPage Today
Source Reference: Walsh N “ICI-Linked Arthritis: Risks for Persistence” 2019.
https://www.medpagetoday.org/rheumatology/arthritis/82546?_ga=2.252979721.1081251847.1570409347-265074527.1569866268More Children Have High Blood Pressure
Hypertension affected 4% of children worldwide, a systematic review and meta-analysis showed.
The prevalence of childhood hypertension rose at a relative rate of 75% to 79% from 2000 to 2015 and was tied to BMI, reported Yajie Zhu, PhD, of the George Institute for Global Health at the University of Oxford in England, and colleagues.
In 2015, childhood hypertension prevalence ranged from 4.32% at age 6 to 3.28% at age 19, peaking at 7.89% at age 14, they reported in JAMA Pediatrics.
“High blood pressure in children is linked to essential hypertension in adulthood and detrimental lifelong cardiovascular effects,” Zhu said. This study is the first review of global childhood hypertension prevalence based on blood pressure measurements from at least three separate occasions, he added.
“In children, the measurement of blood pressure is relatively complicated and unstable, so it needs to be repeated across at least three different visits to avoid false positive cases,” he told MedPage Today. “Until recently, reliable estimates of childhood hypertension prevalence were lacking.” A previous meta-analysis reported the pooled prevalence of childhood hypertension at 11.2%, for example, but that analysis included studies with only one blood pressure measurement.
Four percent prevalence is important, noted Stephen Daniels, MD, PhD, of the University of Colorado in Aurora, in an accompanying editorial. It suggests “hypertension is relatively common in children and adolescents, meaning that pediatricians will see children with hypertension in routine clinical practice.”
Pediatric hypertension prevalence has been hard to define for several reasons, Daniels pointed out.
“Blood pressure changes normally with increasing age and body size, which means that establishing a single set of numbers for systolic and diastolic blood pressure elevation is difficult, especially for younger children,” he explained.
Because blood pressure is so variable, hypertension definitions require systolic or diastolic blood pressure to be persistently in the ≥95th percentile on three separate occasions, an approach recommended for children up to age 13 years in the most recent American Academy of Pediatrics clinical practice guidelines. Adult guidelines for elevated blood pressure (120-129/<80 mm Hg) and hypertension (blood pressure >130/80 mm Hg) are used for children ages ≥13 years, but these measurements also need to be elevated persistently on three separate occasions.
This systematic review included 47 studies of children, ages 6 to 19, from 1994 to 2018 with at least three separate blood pressure measurements. Because studies included were performed before new guidelines became available, the researchers used standardized definitions of hypertension based on the fourth report from the National High Blood Pressure Education Program (NHBPEP) working group for children and adolescents. Cutoffs of high blood pressure accounted simultaneously for variations in age, sex, and height.
Pooled prevalence estimates in each category were:
Obese (15.27%, 95% CI 7.31%-25.38%) and overweight (4.99%, 95% CI 2.18%-8.81%) children had substantially higher prevalence than children with normal weight (1.90%, 95% CI 1.06%-2.97%), the authors noted.
A look at 2015 data showed hypertension prevalence was 4.32% (95% CI 2.79%-6.63%) at age 6, 7.89% (95% CI 5.75%-10.75%) at age 14, and 3.28% (95% CI 2.25%-4.77%) at age 19. “This finding is consistent with the clinical observation of adolescents with persistently high blood pressure, especially during periods of rapid growth in height, who can then have normal blood pressure later in adolescence and young adulthood,” Daniels wrote. “It is important for adolescents with hypertension to be followed up over time to determine which adolescents will become healthier and which will develop persistent hypertension.”
The analysis had several limitations, the researchers noted. Underlying studies had substantial heterogeneity, and the limited number of studies about pre-hypertension and stage 1 and stage 2 hypertension increased the uncertainty of pooled prevalence estimates.
The prevalence of childhood hypertension rose at a relative rate of 75% to 79% from 2000 to 2015 and was tied to BMI, reported Yajie Zhu, PhD, of the George Institute for Global Health at the University of Oxford in England, and colleagues.
In 2015, childhood hypertension prevalence ranged from 4.32% at age 6 to 3.28% at age 19, peaking at 7.89% at age 14, they reported in JAMA Pediatrics.
“High blood pressure in children is linked to essential hypertension in adulthood and detrimental lifelong cardiovascular effects,” Zhu said. This study is the first review of global childhood hypertension prevalence based on blood pressure measurements from at least three separate occasions, he added.
“In children, the measurement of blood pressure is relatively complicated and unstable, so it needs to be repeated across at least three different visits to avoid false positive cases,” he told MedPage Today. “Until recently, reliable estimates of childhood hypertension prevalence were lacking.” A previous meta-analysis reported the pooled prevalence of childhood hypertension at 11.2%, for example, but that analysis included studies with only one blood pressure measurement.
Four percent prevalence is important, noted Stephen Daniels, MD, PhD, of the University of Colorado in Aurora, in an accompanying editorial. It suggests “hypertension is relatively common in children and adolescents, meaning that pediatricians will see children with hypertension in routine clinical practice.”
Pediatric hypertension prevalence has been hard to define for several reasons, Daniels pointed out.
“Blood pressure changes normally with increasing age and body size, which means that establishing a single set of numbers for systolic and diastolic blood pressure elevation is difficult, especially for younger children,” he explained.
Because blood pressure is so variable, hypertension definitions require systolic or diastolic blood pressure to be persistently in the ≥95th percentile on three separate occasions, an approach recommended for children up to age 13 years in the most recent American Academy of Pediatrics clinical practice guidelines. Adult guidelines for elevated blood pressure (120-129/<80 mm Hg) and hypertension (blood pressure >130/80 mm Hg) are used for children ages ≥13 years, but these measurements also need to be elevated persistently on three separate occasions.
This systematic review included 47 studies of children, ages 6 to 19, from 1994 to 2018 with at least three separate blood pressure measurements. Because studies included were performed before new guidelines became available, the researchers used standardized definitions of hypertension based on the fourth report from the National High Blood Pressure Education Program (NHBPEP) working group for children and adolescents. Cutoffs of high blood pressure accounted simultaneously for variations in age, sex, and height.
Pooled prevalence estimates in each category were:
- Hypertension: 4.00% (95% CI 3.29%-4.78%)
- Pre-hypertension: 9.67% (95% CI 7.26%-12.38%)
- Stage 1 hypertension: 4.00% (95% CI 2.10%-6.48%)
- Stage 2 hypertension: 0.95% (95% CI 0.48%-1.57%)
Obese (15.27%, 95% CI 7.31%-25.38%) and overweight (4.99%, 95% CI 2.18%-8.81%) children had substantially higher prevalence than children with normal weight (1.90%, 95% CI 1.06%-2.97%), the authors noted.
A look at 2015 data showed hypertension prevalence was 4.32% (95% CI 2.79%-6.63%) at age 6, 7.89% (95% CI 5.75%-10.75%) at age 14, and 3.28% (95% CI 2.25%-4.77%) at age 19. “This finding is consistent with the clinical observation of adolescents with persistently high blood pressure, especially during periods of rapid growth in height, who can then have normal blood pressure later in adolescence and young adulthood,” Daniels wrote. “It is important for adolescents with hypertension to be followed up over time to determine which adolescents will become healthier and which will develop persistent hypertension.”
The analysis had several limitations, the researchers noted. Underlying studies had substantial heterogeneity, and the limited number of studies about pre-hypertension and stage 1 and stage 2 hypertension increased the uncertainty of pooled prevalence estimates.
Last Updated October 07, 2019
Zhu disclosed no relevant relationships with industry. A co-author
disclosed relationships with the National Institute for Health Research
Oxford Biomedical Research Centre, British Heart Foundation, Economic
and Social Research Council, Research Councils UK, Oxford Martin School,
and relevant relationships with PLOS Medicine, and BMJ Heart.
Daniels disclosed no relevant relationships with industry.
Daniels disclosed no relevant relationships with industry.
Primary Source
JAMA Pediatrics
Kroger, Walgreens to stop sales of e-cigarettes
Kroger Co and Walgreens Boots Alliance Inc said on Monday they would stop selling e-cigarettes at their stores, amid heightened regulatory scrutiny of the product and reports of lung disease and some deaths linked to vaping.
Their move comes weeks after Walmart Inc said it was pulling the plug
on e-cigarette sales, citing growing federal, state and local
regulatory complexity and uncertainty.
E-cigarettes and other vaping products have been linked to a mysterious lung illness that is reported to have led to 18 deaths as of last week, with the number of confirmed and probable cases of the condition exceeding 1,000, according to the U.S. Centers for Disease Control and Prevention (CDC).
Kroger said it would discontinue sales of e-cigarettes at its stores and fuel centers after selling through its current inventory.
Walgreens said it had decided to stop selling e-cigarette products at its U.S. stores as the CDC, the U.S. Food and Drug Administration (FDA) and other health officials continue to examine the issue.
The drugstore chain, which earlier this year set a minimum age to sell tobacco products at 21 years, said the decision was also reflective of developing regulations in a growing number of states and municipalities.
New York and Michigan have already banned the sales of flavored vaping products, while the Trump administration has announced plans to remove all flavored e-cigarettes from store shelves as officials warned that sweet flavors had drawn millions of children into nicotine addiction.
Kroger operates more than 2,700 stores, including over 1,500 fuel stations, while Walgreens runs nearly 10,000 drugstores in the United States.
E-cigarettes and other vaping products have been linked to a mysterious lung illness that is reported to have led to 18 deaths as of last week, with the number of confirmed and probable cases of the condition exceeding 1,000, according to the U.S. Centers for Disease Control and Prevention (CDC).
Kroger said it would discontinue sales of e-cigarettes at its stores and fuel centers after selling through its current inventory.
Walgreens said it had decided to stop selling e-cigarette products at its U.S. stores as the CDC, the U.S. Food and Drug Administration (FDA) and other health officials continue to examine the issue.
The drugstore chain, which earlier this year set a minimum age to sell tobacco products at 21 years, said the decision was also reflective of developing regulations in a growing number of states and municipalities.
New York and Michigan have already banned the sales of flavored vaping products, while the Trump administration has announced plans to remove all flavored e-cigarettes from store shelves as officials warned that sweet flavors had drawn millions of children into nicotine addiction.
Kroger operates more than 2,700 stores, including over 1,500 fuel stations, while Walgreens runs nearly 10,000 drugstores in the United States.
https://www.marketscreener.com/news/Kroger-Walgreens-to-stop-sales-of-e-cigarettes-amid-U-S-vaping-crackdown–29345304/
3 newborns die, 5 ill amid waterborne bacterial infection in Pa. hospital
A Pennsylvania hospital says it is transferring some infants
following a bacterial infection in its neonatal intensive care unit that
affected eight newborns, three of whom have died.
Geisinger Medical Center in Danville said Monday that four of the babies have recovered and one is still being treated with antibiotics.
The hospital said all of the babies had been born prematurely, and
the three deaths “may have been a result of the infection complicating
their already vulnerable state due to extreme prematurity.”
Officials say they are working with state and federal health authorities to make sure the pseudomonas waterborne bacterial infection has been eradicated.
As a precaution, the hospital is transferring babies born at less than 32 weeks to other hospitals and diverting other expected premature deliveries to other hospitals.
https://www.fox2detroit.com/news/3-newborns-die-5-others-sickened-amid-outbreak-of-waterborne-bacterial-infection-in-hospital
Geisinger Medical Center in Danville said Monday that four of the babies have recovered and one is still being treated with antibiotics.
Officials say they are working with state and federal health authorities to make sure the pseudomonas waterborne bacterial infection has been eradicated.
As a precaution, the hospital is transferring babies born at less than 32 weeks to other hospitals and diverting other expected premature deliveries to other hospitals.
https://www.fox2detroit.com/news/3-newborns-die-5-others-sickened-amid-outbreak-of-waterborne-bacterial-infection-in-hospital
Cel-Sci -2.4% amid report it’s misleading on therapy
Cel-Sci (NYSEMKT:CVM) is down 2.4% postmarket after Stat News’ Adam Feuerstein posts a critical piece on the company’s disclosures about its immunotherapy Multikine.
The company has “misled investors repeatedly” about the treatment, which is “still destined to fail. (In fact, it already has.)”
Last January Feuerstein said a Phase 3 clinical
trial was doomed to a negative outcome, but says his error was not
appreciating the extent to which the company would issue “a steady flow
of misleading and erroneous information.”
https://seekingalpha.com/news/3504349-cel-sci-minus-2_4-percent-amid-report-misleading-therapy
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