Veggies, Fruits and Grains Keep Your Heart Pumping

  

As if you needed any more proof that fruits, vegetables and whole grains are good for you, a new study finds they may cut your chances of heart As if you needed any more proof that fruits, vegetables and whole grains are good for you, a new study finds they may cut your chances of heart failure by 41%.

Conversely, the so-called Southern diet, which focuses on meats, fried and processed foods and lots of sweet tea, was tied to a 72% increased risk of heart failure.

"Eat more plants, limit red and processed meat," said lead researcher Dr. Kyla Lara, a cardiology fellow at the Mayo Clinic in Rochester, Minn.

Lara cautioned that this study cannot prove different diets cause or prevent heart failure, only that they are linked.

Nearly 6 million American adults suffer from heart failure, and that number is expected to rise with the aging population. The condition occurs when the heart does not pump blood sufficiently to meet the body's needs.

Steps to prevent heart failure include not smoking, keeping blood pressure under control, maintaining a healthy weight and eating healthy foods.

Getting people to eat healthier requires that they be educated about the benefits of plant-based diets and have access to low-cost healthy foods, Lara said.

"Animal meat is not necessary for a nutritious diet, in terms of health promotion and quality of life," she said. "Now is the time to get on board with a plant-based diet -- it's going to be the future of health."

In the study, Lara and her colleagues collected data on more than 16,000 men and women, 45 and older, who took part in a large U.S. stroke study. None of the participants had heart disease at the start of the study. Participants completed a questionnaire that asked them about their diet.

The diets were classified into five types:

Convenience, which was heavy on meats, pasta, Mexican food, pizza and fast food.

Plant-based, which included vegetables, fruits, beans and fish.

Sweets and fats, which was heavy on desserts, bread, sweet breakfast foods, chocolate and other sugars.

Southern, which was heavy on fried foods, processed meats, eggs, added fats, and sugar-sweetened drinks.

Alcohol and salads, which was heavy on wine, liquor, beer, leafy greens and salad dressing.

After nearly nine years of follow-up, 363 participants developed heart failure.

The benefit of the plant-based diet was significant, but after taking into account factors such as weight, waist size, high blood pressure and high cholesterol, the negative effect of the Southern diet was no longer statistically significant, Lara said.

It might be that the increased risk for heart failure in this group was due to obesity and excess belly fat or other factors, she said.

None of the other diets showed a statistically significant association with heart failure, and no association was seen between any diet and the type of heart failure people developed, the researchers noted.

The findings were published April 22 in the Journal of the American College of Cardiology.

"Our lifestyle, such as what we eat, if we are physically active and smoking or vaping, can contribute significantly to a poorly functioning heart, which in turn affects our quality of life and ultimately how soon we die," said Samantha Heller, a senior clinical nutritionist at New York University Medical Center in New York City.

Plant-based diets have been shown to reduce the risk of cardiovascular disease, cognitive [thinking] decline, type 2 diabetes, several cancers, depression and obesity," said Heller, who wasn't involved with the study.

For optimal health, people need to cut back on fried foods, cheese, fast food and junk foods, and processed and red meats, she said.

"It is sad and frustrating when I see patients who could quite literally save their lives by making healthier choices, but instead opt for a burger and fries," Heller said.

A cheeseburger, fries and milkshake meal sounds innocent enough, but it can add up to more than 2,600 calories, 65 grams of saturated fat and 3,400 milligrams of salt, she said.

Heller advises people to include a minimum of one high-fiber food to every meal. "Dietary fiber is only found in plant foods, such as spinach, oranges, quinoa and lentils."

Also try having meatless dinners two or three nights a week, like a grilled vegetable and black bean burrito, pasta primavera or an edamame and fresh vegetable stir fry, she suggested.failure by 41%.

Conversely, the so-called Southern diet, which focuses on meats, fried and processed foods and lots of sweet tea, was tied to a 72% increased risk of heart failure.

"Eat more plants, limit red and processed meat," said lead researcher Dr. Kyla Lara, a cardiology fellow at the Mayo Clinic in Rochester, Minn.

Lara cautioned that this study cannot prove different diets cause or prevent heart failure, only that they are linked.

Nearly 6 million American adults suffer from heart failure, and that number is expected to rise with the aging population. The condition occurs when the heart does not pump blood sufficiently to meet the body's needs.

Steps to prevent heart failure include not smoking, keeping blood pressure under control, maintaining a healthy weight and eating healthy foods.

Getting people to eat healthier requires that they be educated about the benefits of plant-based diets and have access to low-cost healthy foods, Lara said.

"Animal meat is not necessary for a nutritious diet, in terms of health promotion and quality of life," she said. "Now is the time to get on board with a plant-based diet -- it's going to be the future of health."

In the study, Lara and her colleagues collected data on more than 16,000 men and women, 45 and older, who took part in a large U.S. stroke study. None of the participants had heart disease at the start of the study. Participants completed a questionnaire that asked them about their diet.

The diets were classified into five types:

• Convenience, which was heavy on meats, pasta, Mexican food, pizza and fast food.

• Plant-based, which included vegetables, fruits, beans and fish.

• Sweets and fats, which was heavy on desserts, bread, sweet breakfast foods, chocolate and other sugars.

• Southern, which was heavy on fried foods, processed meats, eggs, added fats, and sugar-sweetened drinks.

• Alcohol and salads, which was heavy on wine, liquor, beer, leafy greens and salad dressing.

After nearly nine years of follow-up, 363 participants developed heart failure.

The benefit of the plant-based diet was significant, but after taking into account factors such as weight, waist size, high blood pressure and high cholesterol, the negative effect of the Southern diet was no longer statistically significant, Lara said.

It might be that the increased risk for heart failure in this group was due to obesity and excess belly fat or other factors, she said.

None of the other diets showed a statistically significant association with heart failure, and no association was seen between any diet and the type of heart failure people developed, the researchers noted.

The findings were published April 22 in the Journal of the American College of Cardiology.

"Our lifestyle, such as what we eat, if we are physically active and smoking or vaping, can contribute significantly to a poorly functioning heart, which in turn affects our quality of life and ultimately how soon we die," said Samantha Heller, a senior clinical nutritionist at New York University Medical Center in New York City.

Plant-based diets have been shown to reduce the risk of cardiovascular disease, cognitive [thinking] decline, type 2 diabetes, several cancers, depression and obesity," said Heller, who wasn't involved with the study.

For optimal health, people need to cut back on fried foods, cheese, fast food and junk foods, and processed and red meats, she said.

"It is sad and frustrating when I see patients who could quite literally save their lives by making healthier choices, but instead opt for a burger and fries," Heller said.

A cheeseburger, fries and milkshake meal sounds innocent enough, but it can add up to more than 2,600 calories, 65 grams of saturated fat and 3,400 milligrams of salt, she said.

Heller advises people to include a minimum of one high-fiber food to every meal. "Dietary fiber is only found in plant foods, such as spinach, oranges, quinoa and lentils."

Also try having meatless dinners two or three nights a week, like a grilled vegetable and black bean burrito, pasta primavera or an edamame and fresh vegetable stir fry, she suggested.

Veggies, Fruits and Grains Keep Your Heart Pumping 

FDA Approves Zulresso (brexanolone) for the Treatment of Postpartum Depression

U.S. Food and Drug Administration   approved Zulresso (brexanolone) injection for intravenous (IV) use for the treatment of postpartum depression (PPD) in adult women. This is the first drug approved by the FDA specifically for PPD.

"Postpartum depression is a serious condition that, when severe, can be life-threatening. Women may experience thoughts about harming themselves or harming their child. Postpartum depression can also interfere with the maternal-infant bond. This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option," said Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. "Because of concerns about serious risks, including excessive sedation or sudden loss of consciousness during administration, Zulresso has been approved with a Risk Evaluation and Mitigation Strategy (REMS) and is only available to patients through a restricted distribution program at certified health care facilities where the health care provider can carefully monitor the patient."

PPD is a major depressive episode that occurs following childbirth, although symptoms can start during pregnancy. As with other forms of depression, it is characterized by sadness and/or loss of interest in activities that one used to enjoy and a decreased ability to feel pleasure (anhedonia) and may present with symptoms such as cognitive impairment, feelings of worthlessness or guilt, or suicidal ideation.

Zulresso will be available only through a restricted program called the Zulresso REMS Program that requires the drug be administered by a health care provider in a certified health care facility. The REMS requires that patients be enrolled in the program prior to administration of the drug. Zulresso is administered as a continuous IV infusion over a total of 60 hours (2.5 days). Because of the risk of serious harm due to the sudden loss of consciousness, patients must be monitored for excessive sedation and sudden loss of consciousness and have continuous pulse oximetry monitoring (monitors oxygen levels in the blood). While receiving the infusion, patients must be accompanied during interactions with their child(ren). The need for these steps is addressed in a Boxed Warning in the drug’s prescribing information. Patients will be counseled on the risks of Zulresso treatment and instructed that they must be monitored for these effects at a health care facility for the entire 60 hours of infusion. Patients should not drive, operate machinery, or do other dangerous activities until feelings of sleepiness from the treatment have completely gone away.

The efficacy of Zulresso was shown in two clinical studies in participants who received a 60-hour continuous intravenous infusion of Zulresso or placebo and were then followed for four weeks. One study included patients with severe PPD and the other included patients with moderate PPD. The primary measure in the study was the mean change from baseline in depressive symptoms as measured by a depression rating scale. In both placebo controlled studies, Zulresso demonstrated superiority to placebo in improvement of depressive symptoms at the end of the first infusion. The improvement in depression was also observed at the end of the 30-day follow-up period.

The most common adverse reactions reported by patients treated with Zulresso in clinical trials include sleepiness, dry mouth, loss of consciousness and flushing. Health care providers should consider changing the therapeutic regimen, including discontinuing Zulresso in patients whose PPD becomes worse or who experience emergent suicidal thoughts and behaviors.

FDA Approves Zulresso (brexanolone) for the Treatment of Postpartum Depression

https://en.wikipedia.org/wiki/Allopregnanolone

FDA Approves Spravato (esketamine) Nasal Spray for Treatment-Resistant Depression

  In continuation of my update on esketamine

The U.S. Food and Drug Administration   approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression). Because of the risk of serious adverse outcomes resulting from sedation and dissociation caused by Spravato administration, and the potential for abuse and misuse of the drug, it is only available through a restricted distribution system, under a Risk Evaluation and Mitigation Strategy (REMS).

"There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition," said Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. "Controlled clinical trials that studied the safety and efficacy of this drug, along with careful review through the FDA’s drug approval process including a robust discussion with our external advisory committees, were important to our decision to approve this treatment. Because of safey concerns, the drug will only be available through a restricted distribution system and it must be administered in a certified medical office where the health care provider can monitor the patient."

Patients with major depressive disorder who, despite trying at least two antidepressant treatments given at adequate doses for an adequate duration in the current episode, have not responded to treatment are considered to have treatment-resistant depression.

The Spravato labeling contains a Boxed Warning that cautions that patients are at risk for sedation and difficulty with attention, judgment and thinking (dissociation), abuse and misuse, and suicidal thoughts and behaviors after administration of the drug. Because of the risk of sedation and dissociation, patients must be monitored by a health care provider for at least two hours after receiving their Spravato dose. The REMS requires the prescriber and the patient to both sign a Patient Enrollment Form that clearly states that the patient understands they should make arrangements to safely leave the health care setting to get home and that the patient should not drive or use heavy machinery for the rest of the day on which they receved the drug. Additionally, Spravato must be dispensed with a patient Medication Guide that outlines the drug’s uses and risks.

The patient self-administers Spravato nasal spray under the supervision of a health care provider in a certified doctor’s office or clinic, and the spray cannot be taken home. The health care provider will instruct the patient on how to operate the nasal spray device. During and after each use of the nasal spray device, the health care provider will check the patient and determine when the patient is ready to leave.

The efficacy of Spravato was evaluated in three short-term (four-week) clinical trials and one longer-term maintenance-of-effect trial. In the three short-term studies, patients were randomized to receive Spravato or a placebo nasal spray. In light of the serious nature of treatment-resistant depresison and the need for patients to receive some form of treatment, all patients in these studies started a new oral antidepressant at the time of randomization and the new antidepressant was continued throughout the trials. The primary efficacy measure was the change from baseline on a scale used to assess the severity of depressive symptoms. In one of the short-term studies, Spravato nasal spray demonstrated statistically significant effect compared to placebo on the severity of depression, and some effect was seen within two days. The two other short-term trials did not meet the pre-specified statistical tests for demonstrating effectiveness. In the longer-term maintenance-of-effect trial, patients in stable remission or with stable response who continued treatment with Spravato plus an oral antidepressant experienced a statistically significantly longer time to relapse of depressive symptoms than patients on placebo nasal spray plus an oral antidepressant.

The most common side effects experienced by patients treated with Spravato in the clinical trials were disassociation, dizziness, nausea, sedation, vertigo, decreased feeling or sensitivity (hypoesthesia), anxiety, lethargy, increased blood pressure, vomiting and feeling drunk.

Patients with unstable or poorly controlled hypertension or pre-existing aneurysmal vascular disorders may be at increased risk for adverse cardiovascular or cerebrovascular effects. Spravato may impair attention, judgment, thinking, reaction speed and motor skills. Patients should not drive or operate machinery until the next day after a restful sleep. Spravato may cause fetal harm and women of reproductive potential should consider pregnancy planning and prevention; women should not breastfeed while being treated.

Esketamine is the s-enantiomer of ketamine. Ketamine is a mixture of two enantiomers (mirror image molecules). This is the first FDA approval of esketamine for any use. The FDA approved ketamine (Ketalar) in 1970.

Ref  https://en.wikipedia.org/wiki/Esketamine

FDA Approves Spravato (esketamine) Nasal Spray for Treatment-Resistant Depression

FDA Approves Sunosi

 Jazz Pharmaceuticals plc   announced that the U.S. Food and Drug Administration (FDA) approved Sunosi (solriamfetol) to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA). Once-daily Sunosi is approved with doses of 75 mg and 150 mg for patients with narcolepsy and doses of 37.5 mg, 75 mg, and 150 mg for patients with OSA. Sunosi is the first dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) approved to treat excessive daytime sleepiness in adults living with narcolepsy or OSA.

Sunosi is expected to be commercially available in the U.S. following the final scheduling decision by the U.S. Drug Enforcement Administration (DEA), which is typically within 90 days of FDA approval.

"Excessive daytime sleepiness can negatively impact the daily lives of people living with narcolepsy or obstructive sleep apnea at work, at home or in daily activities. With this approval, a new, daytime medicine that can provide sustained wakefulness throughout the day will be available for patients," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. "The FDA approval of Sunosi also represents an important milestone for Jazz as we continue to offer new treatment options that address unmet needs for people living with chronic, and often debilitating, sleep disorders."

At Week 12, 150 mg of Sunosi for narcolepsy patients and all doses for OSA patients demonstrated improvements in wakefulness compared to placebo as assessed in test sessions 1 (approximately one hour post-dose) through 5 (approximately nine hours post-dose) of the maintenance of wakefulness test (MWT).

The FDA's approval of Sunosi is based on data from the Treatment of Obstructive sleep apnea and Narcolepsy Excessive Sleepiness (TONES) Phase 3 clinical program, which included four randomized placebo-controlled studies that demonstrated the superiority of Sunosi relative to placebo. The most common adverse reactions (incidence ≥5% and higher than placebo) reported in both the narcolepsy and OSA study populations were headache, nausea, decreased appetite, and anxiety. Sunosi was evaluated in more than 900 adults with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea and was shown to maintain its effect relative to placebo after six months of use.

"We're excited about this new therapeutic option for patients, and we are pleased with the information included in the Sunosi label as we believe it will give physicians the information needed to appropriately manage the vast majority of obstructive sleep apnea and narcolepsy patients with excessive daytime sleepiness," said Daniel Swisher, president and chief operating officer of Jazz Pharmaceuticals.

In 12 week clinical studies, approximately 68-74% of people taking Sunosi at the 75 mg dose and 78-90% of people taking Sunosi at the 150 mg dose reported improvement in their overall clinical condition, as assessed by the Patient Global Impression of Change (PGIc) scale.

Although the exact mechanism of action is unknown, the effects of Sunosi are thought to be mediated through its activity as a DNRI.

"Sunosi is an effective treatment option with a novel mechanism of action as a dual-acting dopamine and norepinephrine reuptake inhibitor," said Richard K. Bogan, MD, FCCP, FAASM, Associate Clinical Professor at the University of South Carolina School of Medicine and Chief Medical Officer at SleepMed in Columbia, SC. "Excessive daytime sleepiness is the most common symptom for people with narcolepsy and a major complaint of people with obstructive sleep apnea. In some people with obstructive sleep apnea, excessive daytime sleepiness may persist despite using CPAP."

Sunosi is not indicated to treat the underlying airway obstruction in OSA. Ensure that the underlying airway obstruction is treated (e.g., with continuous positive airway pressure (CPAP)) for at least one month prior to initiating Sunosi for excessive daytime sleepiness in OSA. Modalities to treat the underlying airway obstruction should be continued during treatment with Sunosi. Sunosi is not a substitute for these modalities.

About Sunosi (solriamfetol)

Sunosi is a dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) indicated to improve wakefulness in adults living with excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea (OSA). In 2014, Jazz Pharmaceuticals acquired a license to develop and commercialize Sunosi from Aerial Biopharma. Jazz Pharmaceuticals has worldwide development, manufacturing, and commercialization rights to Sunosi, excluding certain jurisdictions in Asia. SK Biopharmaceuticals, the discoverer of the compound, maintains rights in 12 Asian markets, including Korea, China and Japan. Sunosi has orphan drug designation for narcolepsy in the United States. 

Important Safety Information

Sunosi can be a target for people who abuse prescription medicines or street drugs. Keep Sunosi in a safe place to protect it from theft. Never give your Sunosi to anyone else, because it may cause death or harm them. Selling or giving away Sunosi may harm others and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.

Do not take Sunosi if you are taking or have stopped taking within the past 14 days a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).

Before taking Sunosi, tell your doctor about all of your medical conditions, including if you:

• have heart problems, high blood pressure, kidney problems, diabetes, or high cholesterol
• have had a heart attack or a stroke
• have kidney problems or diabetes
• have a history of mental health problems, (including psychosis and bipolar disorders), or of drug or alcohol abuse or addiction
• are pregnant or planning to become pregnant. It is not known if Sunosi will harm your unborn baby.
• Pregnancy Registry: There is a pregnancy registry for women who take Sunosi during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your doctor about how you can take part in this registry.
• are breastfeeding or plan to breastfeed. It is not known if Sunosi passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take Sunosi.

Especially tell your healthcare provider if you take a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).

Ref : https://en.wikipedia.org/wiki/Solriamfetol

FDA Approves Sunosi (solriamfetol) for Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea..

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