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Monday, September 14, 2020

‘Startling’ Decline in BP Control Among American Adults

After years of improvement, the number of Americans whose blood pressure (BP) is under control is declining, suggest two new analyses of data from the National Health and Nutrition Examination Survey (NHANES).

One analysis, presented at the American Heart Association’s (AHA’s) virtual Hypertension 2020 meeting, found that Americans with adequate BP control (defined as <140/90 mmHg) dropped by 11% between 2013–2014 and 2017–2018.

“We cannot assume improvement in blood pressure management will continue, even after 35 years of success,” lead author Brent M. Egan, MD, professor, University of South Carolina School of Medicine, Greenville, South Carolina, said in a news release.

A similar pattern was observed in a separate report that was based on data from more than 18,000 NHANES participants with hypertension. That analysis showed a substantial decline in BP control from about 54% in 2013–2014 to roughly 44% in 2017–2018, despite encouraging increases in BP control from 1999–2000 to 2013–2014.

People who had visited a healthcare provider within the past year were six times as likely to have controlled BP compared to those who had not.

“What we found was startling and concerning,” lead author Paul Muntner, PhD, professor of epidemiology and associate dean for research, School of Public Health, University of Alabama at Birmingham, told Medscape Medical News.

“We found that the strongest predictor of uncontrolled BP was not going to the doctor, which is especially relevant during this time of COVID-19, when so many people are not going to the doctor for their follow-up visits because they are afraid of being exposed to people who might be infected,” he said.

This study was published online September 9 in JAMA.

After years of improvement, the number of Americans whose blood pressure (BP) is under control is declining, suggest two new analyses of data from the National Health and Nutrition Examination Survey (NHANES).

One analysis, presented at the American Heart Association’s (AHA’s) virtual Hypertension 2020 meeting, found that Americans with adequate BP control (defined as <140/90 mmHg) dropped by 11% between 2013–2014 and 2017–2018.

“We cannot assume improvement in blood pressure management will continue, even after 35 years of success,” lead author Brent M. Egan, MD, professor, University of South Carolina School of Medicine, Greenville, South Carolina, said in a news release.

A similar pattern was observed in a separate report that was based on data from more than 18,000 NHANES participants with hypertension. That analysis showed a substantial decline in BP control from about 54% in 2013–2014 to roughly 44% in 2017–2018, despite encouraging increases in BP control from 1999–2000 to 2013–2014.

People who had visited a healthcare provider within the past year were six times as likely to have controlled BP compared to those who had not.

“What we found was startling and concerning,” lead author Paul Muntner, PhD, professor of epidemiology and associate dean for research, School of Public Health, University of Alabama at Birmingham, told Medscape Medical News.

“We found that the strongest predictor of uncontrolled BP was not going to the doctor, which is especially relevant during this time of COVID-19, when so many people are not going to the doctor for their follow-up visits because they are afraid of being exposed to people who might be infected,” he said.

This study was published online September 9 in JAMA.

Reversing Years of Progress

In 2014, the eighth Joint National Committee hypertension guideline (JNC8) raised the BP goal to <150/90 mmHg for adults aged ≥60 years who did not have diabetes; but in 2017, the American College of Cardiology and American Heart Association (AHA/ACC) released a guideline that lowered the BP target to <130/90 mmHg for all adults.

Egan and colleagues found that, prior to the JNC8 guideline, BP control among NHANES participants rose from 32.2% in 1999–2000, peaked at 54.5% in 2013–2014, then fell to 48.0% in 2015–2016. It declined further to 43.4% in 2017–2018.

“Despite the 2017 BP goal of <130/<90 in all adults, control of <140/<90 continued to fall in 2017–2018,” the authors report. There was an 11.1% decline from 2013–2014 (P < .001).

The number of adults aged 40 to 59 years with successfully treated BP declined by almost 10% between 2009–2012 and 2015–2018 (56.3% vs 46.6%). Among adults aged ≥60 years, it declined by 6% (from 53.6% to 47.9%).

Systolic blood pressure (SBP) rose 3–4 mmHg in all age groups (P < .01).

The decline in BP control seen in adults aged ≥60 years reflected lower treatment efficiency, whereas the decline in BP control in adults aged 40–59 years reflected less awareness and treatment, the authors note.

“Thus, declining control was not fully explained by BP targets for adults ≥60 years and subsequent controversy,” they state.

“Worrisome” Findings

In a separate report by Muntner and colleagues that was published in JAMA, researchers analyzed cross-sectional NHANES data beginning in 1999–2000 and ending in 2017–2018.

In particular, they analyzed data on 18,262 participants (aged ≥18 years) who had hypertension (defined as BP ≥140/90 mmHg or use of antihypertensive medication) from among the total number of participants included in the NHANES analysis (N = 51,761 participants; mean age, 48 years; 50.1% female).

Among participants, 43.2% were non-Hispanic White adults, 26.1% were Hispanic adults, 21.6% were non-Hispanic Black adults, and 5.3% were non-Hispanic Asian adults.

From among the 18,262 participants with hypertension, the age-adjusted estimated proportion of patients with controlled BP increased between 1999–2000 and 2007–2008 (P < .001), continuing to increase between 2007–2008 and 2013–2014 (P < .14), but then declined during the period 2017–2018 (P < .003).

PeriodParticipants with BP control (%)
1999 – 200031.8
2007 – 200848.5
2013 – 201453.8
2017 – 201843.6

Compared with adults aged 18 to 44 years, controlled BP was more likely among individuals aged 45 to 64 years (49.7% vs 36.7%) and less likely among those aged ≥75 years (37.3% vs 36.7%).

There was a dramatic difference in BP control between people who had a usual healthcare facility compared to those who did not (48.4% vs 26.5%) and between those who had vs those who had not visited a healthcare provider in the past year (49.1% vs 8.0%).

“This is a little worrisome, and our findings reinforce the message that it is important to go to the doctor and get BP checked, and if it is high, the patient can be started on medication or can have the dose adjusted,” Muntner commented.

Racial Disparities

Non-Hispanic Black adults were less likely to have controlled BP compared to non-Hispanic White adults. Individuals without health insurance were also less likely to have successfully controlled BP.

Similar to the findings of Egan and colleagues, awareness of hypertension increased between 1999–2000 and 2013–2014 (from 69.9% to 84.7%), but then declined to 77.0% in 2017–2018.

In 2017–2018, awareness of having hypertension was greater among non-Hispanic Black participants compared to non-Hispanic White, Asian, and Hispanic participants, but rates of BP control were lower.

“There have been good public health campaigns to raise awareness of hypertension among African Americans, and they are equally likely to be treated, but rates of BP control are a little lower,” Muntner observed.

“I think it comes down to making sure everyone has access [to care], reducing disparities, having pharmacies or mail order pharmacies where everyone can get the right medications that are effective in lowering BP,” he added.

Addressing Disparities

Commenting on both studies for Medscape Medical News, Robert M. Carey, MD, professor of medicine, University of Virginia, Charlottesville, Virginia, said, “Unfortunately, the recent increase in adults with BP out of control likely reflects the 2014 recommendation to relax control. In 2017, however, the importance of tight blood pressure control was reaffirmed and the goal blood pressure reduced by the 2017 ACC/AHA clinical practice guideline.”

Carey was co-chair of the writing committee for the 2017 ACC/AHA guideline and was not involved in either study. He noted that the findings do not “reflect changes in blood pressure control after the 2017 guideline was published and disseminated to the clinical practice community, and we can anticipate improvement in control as a result of the recommendations in this guideline.”

Paul Whelton, MB, MD, Show Chwan Chair in Global Public Health, Department of Epidemiology Tulane University School of Public Health and Tropical Medicine Tulane University of Medicine, New Orleans, Louisiana, agreed. In recommending higher levels of BP control, he said, the JNC8 report perhaps “put some confusion out there that may have said to people, ‘You can back off, you don’t have to be so strict’ ” with BP control, he told Medscape Medical News.

Whelton was chair of the writing committee of the 2017 ACC/AHA guideline and was not involved in either study. He emphasized that lifestyle improvement “should always be the core management strategy for prevention and treatment of high blood pressure, to which drugs should be added in certain settings.”

In an editorial that accompanied the report in JAMA, Gregory Curfman, MD, and colleagues suggest that it “will be crucial to repeat the analyses of Muntner et al in another 5 years to determine whether progress has been achieved, with direction provided by the 2017 US and 2018 European guidelines.”

A second editorial in JAMA, written by Griffin Rodgers, MD, and Gary Gibbons, MD, of the National Institutes of Health, noted that non-Hispanic Black adults had poorer BP control than non-Hispanic White adults.

“If the US is committed to changing the trend line of health disparities in obesity and hypertension, it is critical to acknowledge the important contributions of systemic racism and the social determinants of health in the context of the current COVID-19 crisis,” they write.

In a statement jointly issued by the American Medical Association (AMA) and the AHA, Susan R. Bailey, MD, president of the AMA, and Mitchell S. V. Elkind, MD, president of the AHA, said that the study by Muntner and colleagues “reinforces the need for all healthcare providers and their patients to prioritize blood pressure control, especially now, as cardiovascular disease places people at greater risk for adverse outcomes associated with COVID-19.”

The AMA has developed a framework for improving BP control and provides online resources to make it easier for clinicians to access the latest evidence-based guidance for the management of patients with hypertension. It is part of the AMA’s and the AHA’s joint Target: BP initiative.

In addition, the AMA and AHA teamed up with a group of national healthcare organizations and ESSENCE on the Release the Pressure campaign to advocate for improved heart health among Black women.

The study authors have received support from the National Heart, Lung, and Blood Institute. Muntner has received grant funding and consulting fees from Amgen, Inc. The original article lists the other authors’ relevant financial relationships. Carey, Whelton, Curfman and coauthors, Rogers, and Gibbons have disclosed no such financial relationships.

Hypertension Scientific Sessions 2020 Virtual Meeting: Presentation MP33, Session MP07.

JAMA. Published online September 9, 2020. Full text; Curfman et al, Editorial; Rogers et al, Editorial

https://www.medscape.com/viewarticle/937364#vp_1

Ex-Allergan CEO Saunders pops up again in ‘blank cheque’ company

Brent Saunders has been out of the limelight for a few months since departing Allergan after its takeover by AbbVie, but now he is back in a leading role at Vesper Healthcare Acquisition, set up to acquire assets in the healthcare sector.

Delaware-incorporated Vesper has filed a with a $400 million initial public offering (IPO) and plans to list on the Nasdaq under the symbol VSRU, with Goldman Sachs and JP Morgan acting as bookrunners.

The focus of the special purpose acquisition company, or SPAC, is firmly in Saunders’ familiar territory of medical aesthetics, eyecare, longevity and wellness categories, although the IPO prospectus indicates Vesper “may pursue targets in any industry”.

Prior to the $63 billion takeover by AbbVie, Allergan’s biggest product was botulinum toxin product Botox, best known as a wrinkle and migraine treatment, and that headed a sizeable medical aesthetics portfolio at the company which also included dermal filler products like Juvederm.

Meanwhile, Saunders’ earlier stint as CEO of eyecare specialist Bausch + Lomb prior to its takeover by Valeant ticks the ophthalmology box.

Saunders took over as CEO of Allergan in 2014 after the generics company Actavis, which he was heading at the time, took over both the Botox maker and its name.

The Federal Trade Commission (FTC) requested as part of the AbbVie takeover that only one Allergan director stay on to join the AbbVie board, leading to Saunders’ departure from the company.

He has also brought along a former colleague to Vesper: Manisha Narasimhan, who was senior vice president of strategic initiatives, portfolio innovation and investor relations at Allergan – having previously worked at Regeneron and as an analyst at Canaccord and Piper Jaffray. She will serve as Vesper’s chief financial officer.

The IPO is offering 40 million units at $10, with each unit consisting of one share of common stock and one-third of a warrant that is exercisable at $11.50. If fully subscribed, that would give Vesper a market value of around $500 million.

More pooled Covid-19 testing as labs struggle to meet demand

The Covid-19 testing bottlenecks in both the US and the UK have become increasingly pressing. One step the US FDA has taken is allowing pooled testing of samples, and this effort had just been stepped up. Verily, owned by the same parent company as Google, has received emergency use authorisation for its new molecular Covid-19 test to be used with up to 12 pooled upper respiratory specimens. Previously the most samples that could be mixed together for testing was five, with LabCorp’s test. Verily is specifically aiming its testing programme at helping people return to school and work, though it warns that pooling samples is only really useful when the expected rate of positive detection is less than 10%. In areas where this is the case, the technique requires only around a quarter to half as many tests as individual testing would. Verily will have to ensure its Clia-certified lab can keep up with demand: Quest Diagnostics, one of the earlier providers of pooled testing, lost a contract with the state of Florida two weeks ago after major delays to thousands of test results.

Note: “Other” includes four antigen tests, two home sampling kits and one IL-6 test.

https://www.evaluate.com/vantage/articles/news/snippets/more-pooled-covid-19-testing-labs-struggle-meet-demand

Early research from 23andMe strengthens link between blood types, Covid-19

A forthcoming study from genetic testing giant 23andMe shows that a person’s genetic code could be connected to how likely they are to catch Covid-19 — and how severely they could experience the disease if they catch it. It’s an important confirmation of earlier work on the subject.

People whose blood group is O seemed to test positive for Covid-19 less often than expected when compared to people with any other blood group, according to 23andMe’s data; people who tested positive and had a specific variant of another gene also seemed to be more likely to have serious respiratory symptoms.

The study, which was released on a preprint server and which has not yet been peer-reviewed, could extend and confirm earlier work on the subject; 23andMe’s study relied on a larger dataset than earlier work and included a more diverse set of participants, the company said. Experts who aren’t affiliated with 23andMe praised the study design and the work.

“They clarify further what our data could only vaguely hint at,” said Tom Hemming Karlsen, a physician at Oslo University Hospital who published an article in the New England Journal of Medicine on genetic links with Covid-19 severity in June, and who was not associated with 23andMe’s work.

But the outside experts also cautioned that the research won’t change treatment decisions.

“It doesn’t have practical implications. There’s no treatment decisions that will be made from it — it’s just an interesting finding,” said Jennifer Lighter, a pediatrician and epidemiologist at NYU Langone who was not involved in the research.

Unlike the study Karlsen and his colleagues ran, which only included people with severe Covid-19 symptoms, 23andMe included people who had both mild and severe cases — which allowed them to draw stronger conclusions, Karlsen said.

The company’s study participants are also more diverse than Karlsen’s, which only studied people in Spain and Italy. However, the 23andMe study’s demographics still don’t fully reflect the population of the United States. A little more than 11% of the people in 23andMe’s studies said they were Latino; less than 3% said they were Black. (Latinos represent about 16% of the U.S. population, while Black people account for about 13% of the population.)

Both Karlsen and 23andMe’s team found that the genes that code for a person’s blood type seemed to be linked to whether a person would test positive for Covid-19; another section of chromosome 3 — referred to in both papers as chr3p21.31 — seemed to be linked to how severe a person’s response would be to a Covid-19 infection.

Janie Shelton, a senior scientist at 23andMe and a lead author of the paper, and her colleagues noted that genetic associations did not seem to explain all the differences between populations; public health experts have noticed that people of color seem to be particularly at risk for Covid-19 due to some of the direct and indirect health effects of inequality and discrimination.

Both studies suggested one gene found in that area on chromosome three — SLC6A20 — might be particularly related to worse outcomes; however, it’s not yet clear how a particular gene could make a meaningful difference in a person’s response to an infection.

Both 23andMe and Karlsen ran the same kind of genetic analysis — a genome-wide association study. This particular method, which tries to find similar patterns in the genetics of people with a particular condition, has significant limitations. Scientists have suggested that the method is most useful when used to analyze hundreds of thousands of genomes.

For most scientists, getting that many samples would be difficult and expensive. But 23andMe has an obvious advantage — it has already sequenced more than 12 million people, according to the company’s website; over a million people agreed to participate in the company’s Covid-19 study.

“I do think that because of the power of our large sample size, we were able to detect that association pretty strongly,” said Shelton.

Without a clear understanding of which genes matter — and why — the impact of genetic studies on Covid-19 treatment plans will be limited.

“We’d have to find out why it’s significant — is it significant because it’s affecting blood clotting?” Lighter asked. “Unless we find out why there’s a difference, we wouldn’t target therapies or [adjust] a risk category.”

Marinus genetic epilepsy drug meets main goal of late-stage study

Marinus Pharmaceuticals Inc said on Monday its experimental treatment for a rare type of genetic epilepsy called CDKL5 deficiency disorder (CDD) met the main goal of reducing seizure frequency in patients in a late-stage trial.

CDD is characterized by difficult-to-control seizures and severe neuro-developmental impairment.

Patients who received the company’s oral drug, ganaxolone, showed a 32.2% reduction in seizure frequency, compared with a 4% decrease in those who received a placebo, meeting the study’s main goal.

The drug, however, did not meet statistical significance across the secondary goals of the trial, which had enrolled 101 patients.

There are currently no approved therapies for CDD, and most children affected by it cannot walk, talk, or feed themselves, Marinus said.

In addition to CDD, ganaxolone is also being tested for refractory status epilepticus, or RSE, a condition in which people fail to respond to two or more commonly used antiepileptic drugs.

Earlier on Monday, the company announced a five-year cost-sharing contract with the Biomedical Advanced Research and Development Authority (BARDA) to support a late-stage study for the treatment of RSE.

Marinus said it plans on filing a marketing application for ganaxolone for the treatment of CDD with the U.S. health regulator in mid-2021.

The Radnor, Pennsylvania-based company said it would also file for EU approval for the drug by the end of the third quarter of 2021.

https://www.reuters.com/article/us-marinus-pharms-study/marinus-genetic-epilepsy-drug-meets-main-goal-of-late-stage-study-idUSKBN2653B6

Centene sector in the green after guidance reaffirmed

Centene (CNC +3.9%) is leading almost all insurers & managed care firms 2 1/2 hours into the session after it reiterated its 2020 non-GAAP EPS guidance of $4.76 – 4.96 that it released in July that included a modest cut in projected revenue.  Consensus outlook is non-GAAP EPS of $4.88 on revenue of $110.57B.

Selected tickers: CVS Health (CVS +1.1%), eHealth (EHTH +3.9%), UnitedHealth Group (UNH +2.8%), Triple-S Management (GTS +2.2%), Molina Healthcare (MOH +5.0%), Humana (HUM +3.4%), Cigna (CI +1.8%), Anthem (ANTM +3.6%)

https://seekingalpha.com/news/3613746-centene-brethren-in-green-after-guidance-reaffirmed