Could Heavier Folks Be at Lower Risk for ALS?

 It's not often that anything good is associated with obesity. Yet heavy folks and those who bulk up as they age may have less risk for the deadly disease amyotrophic lateral sclerosis (ALS), a new study

finds.
The Norwegian study found that over several decades, people who packed on the most weight had a 37% lower risk of ALS compared to those who maintained their figure or got thinner.
ALS -- also called Lou Gehrig's disease -- is a rare neurodegenerative disease that kills nerve cells in the brain and spinal cord. You lose control of your muscles, which can lead to paralysis and death two to five years after diagnosis, researchers said.
"This study provides a basis for future research to focus on possibilities to prevent or treat ALS on factors linked to body size and energy expenditure," said lead researcher Dr. Ola Nakken.
Nakken, of the University of Oslo in Norway, cautioned that these findings can't prove that being overweight prevents ALS, as only an association was observed. Nor should you think the findings give you license to fatten up. They don't, he said.
Although the reasons why weight might be protective aren't known, Nakken thinks that increased bulk may add to a person's energy reserve.
"It has become increasingly clear that motor neurons, which are the main cells involved in ALS, are remarkably vulnerable to energy depletion," Nakken said.
It's also possible that genetic factors that lower the risk for ALS may also play a part in weight gain, without one causing the other. In addition, environmental factors may be associated with both weight and the risk of ALS, the researchers said.
"Physical activity and smoking are examples of such factors. However, adjusting for this in our study did not change the results," Nakken said.
According to the ALS Association, about 5,000 Americans are diagnosed with ALS each year. The disease usually strikes people between the ages of 40 and 70, but can occur earlier.
Family history of ALS plays no role in 90% of the cases. The other 10% are caused by an inherited gene mutation.
For the study, Nakken and his team collected data on nearly 1.5 million Norwegians ages 20 to 70 between 1963 and 1975. They tracked cases of ALS until 2017. Nearly 3,000 developed the disease in that time period, with most followed an average of 33 years.
Those who started out at a normal weight but gained pounds over time had a 17% lower risk for ALS for each 5-point increase in body mass index (BMI), the study found. BMI is a measurement of body fat based on height and weight.
Over the length of the study, those who were obese when it began had 34% lower odds of developing ALS, compared with those with low to normal BMI. Overweight people had an 18% lower risk, the researchers reported.
The study results were published online June 26 in the journal Neurology.
However, some cautions are in order, one neurologist suggested.
The understanding of how ALS and other neurodegenerative diseases develop doesn't include weight as either a cause or a preventative, said Dr. Carmel Armon, from the department of neurology at Tel Aviv University Sackler School of Medicine in Israel.
"We also cannot speculate that elevated BMI directly increases the resistance of the motor neurons to the development of ALS," he said.
Armon is co-author of an accompanying journal editorial. He warned against gaining weight in the hope of preventing ALS.
"The health risks of high BMI outweigh any protective effect it might confer on ALS occurrence," Armon said. "The findings do not allow us to conclude such a protective effect exists."

Just 30 Minutes of Light Exercise a Week May Keep Deadly Stroke at Bay

 Just a little exercise may help protect you against a type of deadly bleeding stroke, a new study suggests.
As many as half of people who suffer a subarachnoid hemorrhage die within three months.
While smoking and high blood pressure have been shown to increase the risk of this deadly stroke, there has been little evidence on whether exercise can help reduce it.
For this study, researchers examined data from about 70,000 people in Finland and concluded that as little as 30 minutes a week of light exercise reduces the risk by about 5%.

The risk falls as the amount of exercise increases, according to the study published June 25 in the journal Scientific Reports.
"Even moderate physical exercise, such as a 30-minute walk or bike ride four days a week reduces the risk... by roughly 20%, regardless of age and gender," principal author Dr. Joni Lindbohm said in a University of Helsinki news release.
"As such, the finding did not really come as a surprise, as exercise is known to work well in preventing many other cardiovascular diseases. However, the extent and comprehensive nature of the benefit among various groups of people was a positive surprise," she added.
The study also found that exercise can reduce the risk caused by smoking and high blood pressure. For smokers, exercise lowers the odds up to two times more than in the general population.
"However, what must not be overlooked is the fact that smoking remains the number one risk factor for [this stroke] and that quitting smoking is the principal way of preventing the appearance of the disorder," Lindbohm said.
Study co-author Dr. Miikka Korja, head of neurosurgery at Helsinki University Central Hospital, reflected on the reduced risk.
"Even with no accurate scientific evidence of the biological mechanism of action produced by exercise... the reduced risk is most likely connected with a reduction in a systemic inflammatory state, which also affects the walls of cerebral arteries," he said.

Vyndaqel

US FDA Accepts Regulatory Submissions for Review of Tafamidis to Treat Transthyretin Amyloid Cardiomyopathy

January 14, 2019 - Pfizer Inc. (NYSE: PFE) announced today that the US Food and Drug

Administration (FDA) accepted for filing the company’s New Drug Applications (NDAs) for tafamidis for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). Pfizer has submitted two NDAs based on two forms of tafamidis: meglumine salt and free acid. Tafamidis is the only product to complete a Phase 3 trial evaluating its efficacy, safety, and tolerability in patients with ATTR-CM, a rare, fatal, and underdiagnosed condition.1,2
The tafamidis meglumine form (20 mg capsule) has been granted Priority Review. The FDA grants Priority Review to medicines that may offer significant advances in treatment or may provide a treatment where no adequate therapy exists. The target Prescription Drug User Fee Act (PDUFA) action date for a decision by the FDA is in July 2019.
The tafamidis free acid form (61 mg capsule) will be under Standard Review. This form is bioequivalent to the 80 mg tafamidis meglumine dose, which was administered as four 20 mg capsules in the pivotal trial; it was developed for patient convenience to enable a single capsule for daily administration. The target PDUFA action date for a decision by the FDA is in November 2019.
“The diagnosis of ATTR-CM is often delayed, primarily because disease awareness is low and patients often present with symptoms similar to more common causes of heart failure. In fact, we believe less than one percent of patients living with this disease are currently diagnosed,” said Brenda Cooperstone MD, Senior Vice President and Chief Development Officer, Rare Disease, Pfizer Global Product Development. “The FDA’s filing acceptance is an encouraging step toward our goal of further raising awareness and providing a treatment option for ATTR-CM patients who are in desperate need of an approved pharmacologic therapy. We look forward to working with the FDA to bring the first treatment for this deadly disease to patients.”
The submission is based on findings from the pivotal Phase 3 Transthyretin Amyloid Cardiomyopathy (ATTR-ACT) study, which evaluated the efficacy, safety, and tolerability of tafamidis meglumine compared to placebo for the treatment of patients with ATTR-CM. In the primary analysis of the study, tafamidis met the primary endpoint, demonstrating a significant reduction in the hierarchical combination of all-cause mortality and frequency of cardiovascular-related hospitalizations compared to placebo over a 30-month period in patients with wild-type or hereditary ATTR-CM (P=0.0006). Tafamidis was well tolerated, with an observed safety profile comparable to placebo.3 The primary results were presented in a Hot Line session at the ESC Congress 2018 in Munich, Germany, and simultaneously published online in the New England Journal of Medicine (NEJM) in August 2018. Results from additional sub-group analyses were presented during the Late Breaking Clinical Trials session at the Heart Failure Society of America 22nd Annual Scientific Meeting in Nashville, TN, in September 2018. For 

Upadacitinib

AbbVie Announces New Drug Application Accepted for Priority Review by FDA for Upadacitinib for Treatment of Moderate to Severe Rheumatoid Arthritis

NORTH CHICAGO, Ill., Feb. 19, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review its New Drug Application (NDA) for upadacitinib for the treatment of adult patients with moderate to severe rheumatoid arthritis. Upadacitinib is an investigational once-daily oral JAK1-selective inhibitor being studied for multiple immune-mediated diseases.1-13 AbbVie anticipates a regulatory decision in Q3 2019.
The NDA is supported by data from the global upadacitinib SELECT Phase 3 rheumatoid arthritis program evaluating more than 4,000 patients with moderate to severe rheumatoid arthritis across five of six Phase 3 studies.3-7 In all SELECT Phase 3 studies, upadacitinib met all primary and ranked secondary endpoints. The most frequent serious adverse events were infections.3-7 Top-line results from these clinical studies were previously announced.
Upadacitinib is also under review by the European Medicines Agency for the treatment of adult patients with moderate to severe rheumatoid arthritis.
About the SELECT Study Program3-8

The robust SELECT Phase 3 rheumatoid arthritis program evaluates more than 4,900 patients with moderate to severe rheumatoid arthritis in six studies, five of which support regulatory submission for upadacitinib. The studies include assessments of efficacy, safety and tolerability across a broad range of rheumatoid arthritis patients. Key measures of efficacy evaluated include ACR responses, Disease Activity Score (DAS28-CRP) and inhibition of radiographic progression.

Cabotegravir and rilpivirine

Janssen Announces Submission of New Drug Application to U.S. FDA For the First Monthly, Injectable, Two-Drug Regimen of Rilpivirine and Cabotegravir for Treatment of HIV

Cork,Ireland, April 29, 2019 – The Janssen Pharmaceutical Companies of Johnson & Johnson have announced that a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA)

has been submitted by ViiV Healthcare for the investigational once-monthly, injectable, two-drug regimen of Janssen’s rilpivirine and ViiV’s cabotegravir for the treatment of HIV in adults whose viral load is suppressed and who are not resistant to cabotegravir or rilpivirine.
The submission is based on the ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) pivotal Phase 3 studies that included more than 1,100 patients from 16 countries. These studies demonstrated that the combination of rilpivirine and cabotegravir, injected monthly, was as effective as a standard of care, daily, oral three-drug regimen in maintaining viral suppression throughout the 48-week study period. These results were presented in March at the 2019 Conference on Retroviruses and Opportunistic Infections.
“We believe this once-monthly injectable regimen has the potential to offer many people living with HIV a treatment option that does not require taking pills every day,” said Brian Woodfall, M.D., Global Head, Development, Infectious Diseases, Janssen Biopharma, Inc. “In our quest to change the trajectory of health for humanity, we will continue to innovate in the field of HIV. We look forward to working with ViiV and the FDA on the steps needed to get the first long-acting injectable HIV treatment to patients.”
This novel regimen is being co-developed as part of a collaboration between Janssen and ViiV Healthcare. The two companies plan to submit regulatory applications for the two-drug regimen of rilpivirine and cabotegravir to the European Medicines Agency, Health Canada and other global agencies in the coming months.
As part of the regulatory submission package to the FDA, a second NDA was submitted for an oral tablet formulation of cabotegravir that would be taken once-daily as an oral lead-in with the already-approved oral tablet formulation of rilpivirine (marketed by Janssen as EDURANT®).
About ATLAS (NCT02951052)
ATLAS is a Phase 3, open-label, active-controlled, multicenter, parallel-group, non-inferiority study designed to assess the antiviral activity and safety of a two-drug regimen of long-acting, injectable rilpivirine and cabotegravir dosed every four weeks compared to continuation of current oral anti-retroviral therapy (ART) of two nucleoside reverse transcriptase inhibitors (NRTIs) plus an integrase strand transfer inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or protease inhibitor (PI) among virally suppressed individuals. The primary endpoint for ATLAS is the proportion of participants with plasma HIV-1 RNA ≥50 c/mL per the FDA Snapshot algorithm at Week 48 (Missing, Switch, or Discontinuation = Failure, Intent-to-Treat Exposed [ITT-E] population). Subjects were required to be virally suppressed for six months or longer, on a first or second regimen, with no prior failure.
About FLAIR (NCT02938520)
FLAIR is a Phase 3, randomized, open-label, multicenter, parallel-group, non-inferiority study designed to assess the antiviral activity and safety of a two-drug regimen of intramuscular, long-acting, injectable rilpivirine and cabotegravir in virologically suppressed adults living with HIV, following 20 weeks of induction therapy with Triumeq® compared to continuation of the oral dolutegravir-based treatment regimen. The primary endpoint for FLAIR is the proportion of participants with plasma HIV-1 RNA ≥50 c/mL per the FDA Snapshot algorithm at Week 48 (Missing, Switch, or Discontinuation = Failure, Intent-to-Treat Exposed [ITT-E] population).
About rilpivirine long-acting

Rilpivirine long-acting is an investigational, injectable, prolonged-release suspension for intramuscular injection being developed by Janssen Sciences Ireland UC and is not approved by regulatory authorities anywhere in the world.
About cabotegravir

Cabotegravir is an investigational integrase inhibitor (INI) and is not approved by regulatory authorities anywhere in the world. Cabotegravir is being developed by ViiV Healthcare for the treatment and prevention of HIV and is currently being evaluated as a long-acting, prolonged-release formulation for intramuscular injection and also as a once-daily oral tablet for short-term use prior to long-acting injection.
About the Janssen Pharmaceutical Companies of Johnson & Johnson

At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
Learn more at www.janssen.com and follow us at www.twitter.com/JanssenGlobal. Janssen Biopharma Inc., and Janssen Sciences Ireland UC are members of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Notice to Investors Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding rilpivirine and development of potential preventive and treatment regimens for HIV. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Sciences Ireland UC, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 30, 2018, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
Source: Janssen Pharmaceutical Companies of Johnson & Johnson

Cooking With Whole Grains

 When it comes to getting the best taste and the greatest nutritional value from grains, keep it whole grain.
Quinoa, oats, short-grain brown rice and wild rice, polenta (which is made from corn) and barley are most nutritious in their whole, unprocessed form. That's because the bran is still intact, and the bran is where most of the minerals, vitamins and plenty of fiber reside.
Processed and packaged foods are rarely made from 100 percent whole grains. Think of them as empty carbs with lots of preservatives, so switch to these flavorful grains to load up on nutrition, including essential minerals and even some protein.
Tip: Don't be fooled by the word "multi-grain" on packages -- this does not mean that a variety of or even any whole grains were used.
Brown rice is high in magnesium and tryptophan, barley is high in selenium and tryptophan, and steel cut oats are high in manganese and zinc. These grains are simple to prepare. Bring water to a boil, add your grains and cook on low heat for about 45 minutes until tender. Remove from the heat and keep covered for 5 minutes to allow the grains to fluff, then stir with a fork.
Quinoa is another excellent choice, high in iron and manganese, plus it's quicker to cook than the other grains. Rinse a cup of dry quinoa under cold running water, then add it to 2 cups of boiling water. Cover and simmer for about 20 minutes.
Use cooked grains in any dish that calls for white rice or pasta. If you're eating them plain, you can still get creative with tasty "add-ins" like dried cranberries on breakfast oatmeal or barley, a drizzle of balsamic on brown rice and a sprinkle of Parmesan on quinoa.
More Great Grains
Amaranth
Bulgur
Buckwheat
Kasha (toasted buckwheat)
Spelt
Farro
Millet

Exercise Secrets to a Better Bottom

 If you're bored with doing squats for a better bottom, it's time to vary your workout.
For a study sponsored by the American Council on Exercise (ACE), scientists at the University of Wisconsin-La Crosse evaluated popular exercises for the glutes to find the ones that are most effective.
Popular Glutes Strength-Training Exercises
Four-way hip extensions
Horizontal leg press
Lunges
Quadruped hip extensions
Single leg squats
Step-ups
Traditional squats
Vertical leg press
The traditional squat is still a great choice, but not the only one. In fact, if you want to target the hamstrings along with the glutes, quadruped hip extensions and step-ups are very effective. So are lunges, single-leg squats and four-way hip extensions.
To get started, the experts at ACE recommend a super set of quadruped hip extensions followed by the step-ups. First, you do both exercises with one leg, and then you repeat them with the other leg, without any rest in between.
For the hip extensions, get on hands and knees and contract your abs a bit to stabilize your core. Next, keeping the right knee bent at a 90-degree angle, lift your right leg until your thigh and the sole of your foot are parallel with the floor. With control, return to the starting position. Do eight to 12 reps.
Immediately move to the step-ups. Stand behind a 15-inch-high step with a dumbbell in each hand. Place your right foot on the step and transfer all your weight to that leg. Push down with your right foot to straighten the leg, bringing yourself up on the step. (Only the right leg is engaged -- the left leg is passive.) Now step down, leading with your right foot. Do eight to 12 reps.
Immediately repeat both exercises with the left leg.
Build up to three full sets of the entire sequence.