How atrial fibrillation can be related to dementia

University of Minnesota Medical School researchers have determined that atrial fibrillation (Afib) is independently associated with changes that occur with aging and dementia.

“Atrial Fibrillation and Brain Magnetic Resonance Imaging Abnormalities” published in Stroke advances researchers’ understanding of the mechanisms underlying atrial fibrillation-related dementia. Jeremy Berman, a University of Minnesota cardiology fellow is the first author of this paper. It had already been determined that Afib is associated with dementia independent of clinical stroke but the mechanisms surrounding the association were still unclear.

“Until this point, most studies which looked into this association were cross-sectional, which have limitations,” said Lin Yee Chen, MD, MS, Associate Professor with tenure, Cardiovascular Division, in the Department of Medicine with the University of Minnesota Medical School. “In our study, brain MRI scans were performed at two different times within ten years.”

The longitudinal analysis included 963 participants without prevalent stroke. They underwent a brain MRI in 1993-95 and a second in 2004-06. Researchers took note of finding such as subclinical cerebral infarctions, sulcal size, ventricular size, and white matter hyperintensity volume and total brain volume.

“We found that people with Afib did have an increase in subclinical cerebral infarction and worsening of sulcal and ventricular grade, which are changes associated with aging and dementia,” said Chen.

“We need to find out why people with atrial fibrillation experience worsening of sulcal grade,” said Chen. “This may involve collaborating with other scientists to understand other pathways we have not yet uncovered. Clearly, Afib is a public health problem which touches on the important theme of heart and brain connections.”

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Story Source:

Materials provided by University of Minnesota Medical School. Note: Content may be edited for style and length.

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Journal Reference:

1. Jeremy P. Berman, Faye L. Norby, Thomas Mosley, Elsayed Z. Soliman, Rebecca F. Gottesman, Pamela L. Lutsey, Alvaro Alonso, Lin Y. Chen. Atrial Fibrillation and Brain Magnetic Resonance Imaging Abnormalities. Stroke, 2019; 50 (4): 783 DOI: 10.1161/STROKEAHA.118.024143

https://www.sciencedaily.com/releases/2019/05/190506093613.htm

Soy protein lowers cholesterol, study suggests

Soy protein has the ability to lower cholesterol by a small but significant amount, suggests a new study led by St. Michael’s Hospital in Toronto.

With the U.S. Food and Drug Administration (FDA) planning to remove soy from its list of heart healthy foods, researchers at St. Michael’s set out to provide a meta-analysis of 46 existing trials that evaluated soy and determine whether the proposed move aligns with existing literature.

Of the 46 trials, 43 provided sufficient data for meta-analysis. Forty-one trials examined the protein’s effects on low-density lipoprotein (LDL) cholesterol, which is often referred to as the “bad cholesterol” because a high amount of it leads to a build-up of cholesterol in arteries. All 43 studies provided data about “total cholesterol,” which reflects the overall amount of cholesterol in the blood.

Researchers found that soy protein reduced LDL cholesterol by three to four percent in adults—a small but significant amount, noted Dr. David Jenkins, the lead author of the study, who is also the director of the Clinical Nutrition and Risk Factor Modification Centre, and a scientist in the Li Ka Shing Knowledge Institute of St. Michael’s Hospital.

“When one adds the displacement of high saturated fat and cholesterol-rich meats to a diet that includes soy, the reduction of cholesterol could be greater,” Dr. Jenkins said. “The existing data and our analysis of it suggest soy protein contributes to heart health.”

A limitation of this study was that it exclusively analyzed the 46 trials the FDA had referred to previously, as opposed to casting a wider net.

Dr. Jenkins and his team hope that this work is taken into account in the FDA’s current evaluation of soy protein as it pertains to heart health.

“We hope the public will continue to consider plant-based diets as a healthy option,” Dr. Jenkins said. “It is in line with Health Canada’s recently released Food Guide, which emphasizes plant protein food consumption by Canadians.”

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More information: Sonia Blanco Mejia et al, A Meta-Analysis of 46 Studies Identified by the FDA Demonstrates that Soy Protein Decreases Circulating LDL and Total Cholesterol Concentrations in Adults, The Journal of Nutrition (2019). DOI: 10.1093/jn/nxz020

https://medicalxpress.com/news/2019-05-soy-protein-lowers-cholesterol.html

GW Pharma scores another Phase 3 win for cannabinoid in rare form of epilepsy

GW Pharmaceuticals can now boast about its fifth straight successful Phase III trial for its cannabinoid drug Epidiolex.

Researchers for the biotech said Monday evening that the drug hit the primary endpoint on both doses tested, with seizure reductions of 48.6% and 47.5% from baseline for patients suffering from tuberous sclerosis complex — another rare form of childhood epilepsy — compared to 26.5% for placebo.
Shares of the biotech $GWPH popped about 6% after the news hit following the closing bell.

“With these data, we look forward to submitting an sNDA to the FDA in the fourth quarter with the goal of expanding the product label in 2020 to help the lives of patients suffering with TSC,” noted GW CEO Justin Gover in a prepared statement.

Already approved for Lennox-Gastaut syndrome and Dravet syndrome, GW Pharma has enjoyed considerable success fielding a drug that many analysts believe is a blockbuster in the making.

It still has a long way to go, though. Q1 sales hit $33.5 million.

GW Pharma scores another PhIII win for its cannabinoid in rare form of epilepsy

Xoma reports Q1 EPS 22c, consensus (12c)

Reports Q1 revenue $8.13M, consensus $4.22M. We continued to execute on our royalty-aggregator business model in 2019. In early April, we announced we are acquiring the potential royalty rights associated with five hematology assets, three of which are being developed under a collaboration with Bayer, and a percentage of the future milestone payments associated with the assets,” stated Jim Neal, Chief Executive Officer of XOMA. “Milestone payments help fuel XOMA’s model, as they are a means of adding non-dilutive capital that can fund our royalty asset acquisitions. As I have articulated in the past, we maintain a lean infrastructure to allow our milestones and royalties to have a meaningful impact on our financial results. This quarter’s $5.5 million milestone payment had a significant positive impact on XOMA’s financial statements.” Novartis (NVS) announced gevokizumab will enter oncology clinical studies. “There was a great deal of activity on XOMA-partnered assets in the first quarter of 2019, including the posting of Novartis’ first clinical study for gevokizumab in oncology. Given all that has happened with gevokizumab over the years, seeing that study posted on ClinicalTrials.gov was a proud moment for everyone at XOMA,” concluded Mr. Neal. Novartis also continued to expand the iscalimab Phase 2 development program and posted two additional Phase 2 trials on ClinicalTrials.gov during the first quarter. The anti-CD40 antibody is being studied in six separate indications across ten ongoing or completed trials.

https://thefly.com/landingPageNews.php?id=2904269

Premier to exit specialty pharmacy business

Premier (PINC) is exiting its specialty pharmacy business to “enhance the company’s focus on the continuing evolution of its core supply chain, enterprise analytics and performance improvement capabilities.” On May 6, certain of Premier’s consolidated subsidiaries entered into a definitive asset purchase and sale agreement with ProCare Pharmacy, a subsidiary of CVS Health Corporation (CVS), under which Premier will sell certain assets related to its specialty pharmacy business for $22.5M, plus up to an additional $20.0M for inventory, each subject to adjustment. The transaction is expected to close in the current quarter ending June 30. The sale was made in connection with the company’s plans to discontinue its specialty pharmacy operations conducted by both Acro Pharmaceutical Services and Commcare Pharmacy by June 30. Net proceeds from the transaction will be used primarily to fund costs associated with the transaction and wind down and exit from the specialty pharmacy operations, and for general corporate purposes. In connection with Premier’s exit from the specialty pharmacy business, the company expects to record a non-cash impairment charge of approximately $87.0M-$92.0M related to goodwill, purchased intangibles and other assets of the specialty pharmacy business. Including costs incurred to date, it also expects to incur one-time, transaction and exit-related pre-tax charges of approximately $11.0M-$15.0M, primarily related to severance and retention benefits and financial advisor and legal fees. These expenses are expected to be recorded in Q4. These actions are expected to increase Premier’s consolidated non-GAAP adjusted EBITDA margin to approximately 45% for Fy19 compared to approximately 34% for the FY19 six-month period ended December 31, 2018, while reducing annual consolidated net revenue by approximately $470M and increasing annual pre-tax income by approximately $6M.

https://thefly.com/landingPageNews.php?id=2904289

Ensign Group Announces Home Health, Hospice and Senior Living Spin-off

The Ensign Group, Inc. (ENSG), the parent company of the Ensign™ group of skilled nursing, rehabilitative care services, home health care, hospice care and senior living companies, announced today a plan to separate its home health and hospice agencies and substantially all of its senior living businesses into a separate publicly-traded company.  Upon consummation of the spin-off, the two companies will include:

• The Ensign Group, Inc., which will include transitional and skilled services, rehabilitative care services, healthcare campuses, post-acute-related new business ventures and real estate investments; and
• The Pennant Group, Inc., which will include Ensign’s home health and hospice operations, substantially all of Ensign’s senior living operations, and Ensign’s mobile diagnostic and clinical laboratory operations.

Ensign plans to effect the strategic separation through a spin-off in which it will distribute shares of Pennant’s common stock to Ensign’s shareholders on a pro rata basis.  At the time of the spin-off, it is anticipated that Pennant, which is currently a wholly-owned subsidiary of Ensign, will consist of 60 home health and hospice agencies, 51 senior living operations, and mobile diagnostics and lab operations located across 13 states. Pennant anticipates 23 of the senior living assets will remain subject to leases with third-party landlords.  In addition, Pennant will operate 28 senior living communities pursuant to a new, long-term triple-net leases with Ensign subsidiaries.

The spin-off is expected to be tax-free to Ensign’s shareholders, except for any cash paid in lieu of fractional shares. Pennant has applied to list its shares on the NASDAQ stock market under the ticker symbol “PNTG.”

Ensign’s current management team will continue in place.  Mr. Daniel H Walker, President of Ensign’s home health and hospice holding company, Cornerstone Healthcare, Inc., will become the Chairman, Chief Executive Officer and President of Pennant. Ensign’s current President and Chief Executive Officer, Mr. Christopher R. Christensen, will also serve as a director for both companies for the foreseeable future.  In addition, Mr. John Nackel, a current Ensign director, will also serve as a Pennant director, and it is anticipated that he will temporarily continue his service on the Ensign board until his replacement is found or the end of his current term, whichever occurs first.

https://finance.yahoo.com/news/ensign-group-inc-announces-home-210723445.html

Mosaic cuts FY19 adj. EPS view to $1.50-$2.00 from $2.10-$2.50

Consensus $2.19

https://thefly.com/landingPageNews.php?id=2904275