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Monday, October 7, 2019

More 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:
  • 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%)
Hypertension had a higher prevalence when measured by aneroid (7.23%) than by mercury (4.59%) or oscillometric sphygmomanometer (2.94%). Systolic hypertension was most common in children and adolescents.
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.

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.

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

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

Pfenex Gets FDA Seal of Approval For Amgen’s Forteo Biosimilar

Shares of the micro-cap biotech Pfenex Inc PFNX 15.7%, which pulled back ahead of the PDUFA date for its Forteo biosimilar PF708, were advancing Monday amid a positive outcome for the binary event.

FDA Hurdle Crossed

The FDA has approved its NDA for PF708 under the 505(b)(2) regulatory pathway, with Amgen, Inc. AMGN 0.81%‘s Forteo as the reference drug.
PF708 has been indicated to treat osteoporosis in certain patients at high risk for fracture.

“The FDA’s approval of PF708 marks a major milestone in Pfenex’s history as our first approved commercial product and further validates our PfÄ“nex Expression Technology platform,” CEO Eef Schimmelpennink said in a statement.
The company said it now looks ahead to continue working with its commercialization partner Alvogen to launch the drug in the U.S.

Cost-Effective Alternative To Forteo

Amgen’s Forteo had global sales of $1.6 billion in 2018.
PF708 has the potential to significantly enhance patient access to a therapy as a cost-efficient alternative to Forteo, according to Pfenex.
Pfenex is seeking a therapeutically equivalent designation to Forteo that would permit automatic substitution of PF708 for Forteo in many states.
For this purpose, the company is conducting a comparative human factor study between the two drugs based on a mandate from the FDA. The company expects to submit the final study report to the FDA as early as the second half of October.

Milestone Payment Kicks In

The FDA approval has made Pfenex eligible to receive a $2.5-million milestone payment from Alvogen.
The company expressed confidence in partner Alvogen’s plans for a commercial launch.
“To optimize patient and payer impact, we currently expect our commercial partner Alvogen to launch PF708 upon an FDA decision on the therapeutic equivalence rating,” according to Pfenex.
https://www.benzinga.com/general/biotech/19/10/14553298/pfenex-gets-fda-seal-of-approval-for-amgens-forteo-biosimilar

Zimmer upped to Buy from Neutral by BTIG

Target $158
https://www.benzinga.com/stock/ZBH/ratings

10X Genomics started at Buy by B of A

https://www.benzinga.com/stock/TXG/ratings