NEL Animal Cardiovascular Center Performs World's First Surgical Treatment of Canine Infective Endocarditis
'This case is the first to prove that surgical treatment can be a viable option for canine infective endocarditis, a condition previously considered inoperable. It is a result of our cumulative experience in over 50 successful mitral valve surgeries."
Share
The South Korean veterinarian team led by Chief Veterinarian Dr. Taeheum Um has conducted a complex procedure using cardiopulmonary bypass (CPB) to resect and reconstruct a heart valve damaged by infection, in a case where conventional medical treatment had proven insufficient. This case marks the world's first successful surgical intervention for canine infective endocarditis.
The patient, an 8-year-old, 6.2 kg Spitz, was a high-risk case with a medical history of Protein-Losing Enteropathy (PLE) and prolonged antibiotic use. The first surgery addressed a degenerative mitral valve damaged by myxomatous changes, significantly reducing regurgitation. The patient recovered well without the need for ongoing medication.
However, approximately four weeks post-op, a bacterial infection developed on the valve. Detailed diagnostics confirmed the presence of infective endocarditis caused by the multi-drug resistant bacterium Enterococcus faecium. The infection was likely due to intestinal barrier damage linked to chronic enteritis and long-term antibiotic treatment. Despite six weeks of intravenous antibiotic therapy, severe structural damage to the valve necessitated a second surgery.
In the second operation, the team performed anterior mitral valve leaflet patch augmentation, extending the shortened anterior leaflet using a bovine pericardial patch. This is a highly advanced technique borrowed from human cardiac surgery — and this marks the first time it has ever been applied to a dog.
The nine-hour procedure was successful, and the patient was able to discontinue all cardiac medications and diuretics. Now, over three months post-surgery, the dog is living a normal life without any syncope episodes. Considering the average survival period for dogs with infective endocarditis is around 70 days, this case — with the patient surviving and improving over 10 months post-onset — is a landmark achievement demonstrating the potential of surgical treatment.
Dr. Taeheum Um, lead surgeon of the NEL Animal Heart Surgery Team, stated, 'This case is the first to prove that surgical treatment can be a viable option for canine infective endocarditis, a condition previously considered inoperable. It is a result of our cumulative experience in over 50 successful mitral valve surgeries. We will continue to monitor the case and publish our findings in academic journals.'
Building on this success, the team aims to expand the clinical scope of treatment for complex canine heart diseases and contribute critical data to the global veterinary cardiology community.
About NEL Animal Cardiovascular Center
The NEL Animal Cardiovascular Center is a 24-hour specialty veterinary hospital with expertise in heart surgery and intensive cardiac care. It also offers services in neurology (disc treatment), advanced diagnostics (CT/MRI), stem cell therapy, and orthopedic surgeries such as cruciate ligament and patella luxation repairs. NEL is the only private animal hospital in South Korea capable of performing both mitral valve surgery and open-heart surgery. The center also operates a specialized heart screening program for early detection and management of cardiac diseases.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
5 hours ago
- Yahoo
We've Tested Countless Protein Powders — These Are the 8 Best for Building Muscle in 2025
There are plenty of excellent natural sources of protein, but when it comes to supporting muscle tissue repair and maximising muscle growth, it's pretty much universally agreed that protein supplements are the most convenient way of topping up your daily protein intake. Choosing the best protein powder to match your goals? That takes some careful consideration. Which is why we've enlisted the help of professional sports nutritionists to share the essential information you need when choosing a protein powder for muscle growth and recovery, before referring to our annual Sports Nutrition Awards to recommend a selection of the best protein powders worth buying in 2025. Best Protein Powder Before we get into our top recommendations, let's go back to basics. Protein powder is essentially powdered and concentrated food. Typically (but not exclusively) derived from either dairy or plant protein, the main benefit of powdered protein is that it's a convenient means of increasing the amount of the essential muscle-building macronutrient present in your diet. The most common types of protein powder are whey protein, the liquid by-product of milk separated from curd during cheese production, soy protein, a concentrated form of plant-based protein originating from soybeans, and casein protein, a slow-digesting dairy protein that like whey protein is also derived from milk. Other types of powdered protein supplements include beef, rice, hemp, egg and pea. From a muscle-building perspective, protein powder has a number of benefits. 'The protein we consume helps augment recovery and new muscle tissue from our resistance training,' says Yiannis Fleming, a sports performance coach and qualified nutritionist. 'As we train and put the muscles under stress, micro-tears occur and it's the protein that helps to repair and develop new tissue.' Heaps of peer-reviewed studies back this. For example, according to one study published in the journal Nutrients, 'protein intake was shown to promote additional gains in lean body mass beyond those observed with resistance exercise alone'. What to Consider From types of protein to dietary requirements, consider the following when choosing the best protein powder for your diet and end goals. Type According to Fleming, it can be helpful to break down protein powder into the following four categories. Also known as mass gainers or muscle gainers, 'these powders are comprised of protein with added carbs and fats to increase your calories', says Fleming. 'If you struggle to consume enough calories each day then a powder like this will assist in increasing your bodyweight and muscle stores.' 'Examples of these powders are whey, casein and those labelled as 'diet" options,' he continues. 'They are mostly comprised of protein with very little added carbs or fats, meaning you can consume around 30g of protein for under 150 calories, which is very low when compared to higher-calorie shakes which can be around 600 calories. Keep in mind that whey is best taken after training as it elicits muscle protein synthesis and will support muscle repairs. Casein, on the other hand, is a slower-absorbing powder and best taken pre-bed to help reduce total body protein breakdown, which occurs when we go long periods without eating, e.g. sleeping.' These are similar to the muscle gainers mentioned before. 'These powders contain additional calories from carbs and fats to help you consume more energy,' says Fleming. 'The only main difference is that these shakes do not contain dairy and thus will have a slightly lower leucine content. For eliciting muscle protein synthesis, a dairy-based powder will likely be the best, but if you can't have dairy, then a shake from this section will be more than fine.' If you're shopping in this category, look for pea, soy, hemp and those labelled as 'dairy-free' options, says Fleming. 'They are mostly comprised of protein, but as they originate from plants they will have slightly less protein and a little bit more carbohydrates,' he says. 'These shakes are not thought to be as effective in eliciting muscle protein synthetic because of their lower leucine content, but they are more advantageous if you are avoiding dairy. You could always combine this shake with a lactose-free milk to further increase the protein content.' Protein Intake Before taking protein powder, consider how much protein you already typically get in your diet. As Fleming puts it: 'Many people are able to consume enough protein from their overall diet that a specific powder may not be required. If you're familiar with tracking on apps like MyFitnessPal and can see that you're consuming within the range of 1.5-2g of protein per kg of bodyweight each day – so for example, if you weigh 80kg then this would be 120-160g – then it may not be essential to add a protein supplement to your routine.' Dietary Requirements Consider your dietary requirements when choosing a protein powder. 'Are you lactose intolerant or experiencing discomfort from taking protein powders like whey or casein?' says Fleming. 'If so, opting for a dairy-free or plant-based alternative is best. Options like pea, soy and hemp are great for those with lactose intolerance and will reduce the likelihood of cramps, pains or IBS symptoms.' Reputable Brands Once you've settled on a type of protein powder, head to a trustworthy retailer. 'For the majority of people, a cost-effective protein powder from a reliable distributor like MyProtein, PhD or The Protein Works will be more than sufficient,' says Fleming. 'These sites offer a wide range and will cover the four main groups I mentioned before. Remember to opt for a dairy-free or plant-based alternative if you are avoiding dairy.' All the retailers on this list meet this criteria. Testing and Certification If you're an athlete who competes professionally, Fleming recommends opting for supplements with an Informed Choice or Informed Sport label. 'These are batch tested to ensure the ingredient list is accurate and to cover you if you're being tested for performance-enhancing drugs.' Both certifications indicate when a sports supplement has been tested for prohibited substances and manufactured to high-quality standards. The difference between the two is the frequency of testing. Informed Sport tests every batch before a product is sold, whereas Informed Choice regularly tests products on a monthly blind testing schedule. How We Selected As part of our 2024 Sports Nutrition Awards and 2025 Sports Nutrition Awards, we recruited a panel of industry experts and fitness enthusiasts, alongside our team of health and fitness journalists and nutritionists, and asked them to put 152 products to the test. Our winning protein powders have our Sports Nutrition Awards badges displayed proudly above their picture below. The remaining entries on our list have been carefully chosen by our editors in line with our experts' recommendations. For each protein powder on this list, we consulted nutrition experts who provided in-depth feedback on each product's nutritional value and impact on exercise performance in order to eliminate supplements with substandard ingredients or inadequate macros. Our team also personally rated each protein powder, ranking their taste, texture and Standard Whey Protein Powder Awarded 'Best Milk Shake' in 2024: 'Many people like to stick to the classics. Chocolate is a busy flavour category, but our ON winner stands out from the crowd for its natural-tasting cocoa flavour and creamy consistency. It scored highly for mixability and, unlike many of the chocolate powders we tried, it wasn't overly sweet. It offers 24g of protein per serving, including 5.5g of BCAAs.' Check out our full list of MH-approved whey protein. £29.95 at Performance Protein Powder Awarded 'Best All-Rounder' in 2024 and 2025: Even when blended with water alone, Form's consistency was ultra- creamy with no unwanted aftertaste. Testers described it as sweet and nutty. The organic blend includes pea, brown rice and pumpkin protein, along with turmeric to support recovery and digestive enzymes. It scored extra points for its eco packaging, which is both plastic-free and compostable. A regular MH award-winner, Form remains the undisputed champ of plant-based protein.] Check out our full list of MH-approved vegan protein. £25.99 at Protein - Chocolate Awarded 'Best New Protein Powder' in 2025: 'We'd expect nothing less than a podium finish from athlete, gym owner and former MH cover star Ollie Marchon's brand. With 24g of protein, a solid amino acid profile and minimal carbs and fats, this mixed well with both water and milk. We're fans of the Salted Caramel.' £33.49 at Whey Protein Awarded Best Clear Whey in 2025: 'With 20g of protein in every serving, minimal sugar and under 90 calories, this easy-drinker is perfectly palatable any time of day. We like Peach Tea but there are more than 15 fruity flavours to choose from, including Blood Orange and Strawberry Kiwi. The powder mixed well and is a fresh alternative to milky blends.' Check out our full list of MH-approved whey protein. £27.99 at MyproteinClear Protein Awarded Best Clear Vegan Protein in 2025: 'The texture of this one won us over; the powder blends easily with water for a drink that packs in 20g of protein and 3.6g of BCAAs – a winner for vegans and dairy-drinkers alike. Blend with ice cubes for a zero-sugar slushy to start your post-gym recovery.' Check out our full list of MH-approved vegan protein. £29.00 at Drink Shake Awarded 'Best for On-The-Go' in 2024: No time for a post-gym meal? Available in many supermarkets, these shakes provide a healthy balance of carbs, protein and fat, along with all 26 essential vitamins and minerals, plus omega 3. Our panel couldn't fault the flavour and said the creamy consistency was bang on. Check out our full list of MH-approved vegan protein. £22.75 at Whey Awarded 'Best for an Energy Boost' in 2024: 'This whey and soya-based blend offers a good mix of protein and fat-burning ingredients, with 17g of protein, 91 calories and 1.4g of fat per serving. It also features L-carnitine – a chemical that helps the body turn fat into energy – and green tea extract, an antioxidant that can aid weight loss.' Check out our full list of MH-approved whey protein. £43.65 at Protein Awarded 'Best for Natural Ingredients' in 2024: 'Made with a blend of pea, sunflower and rice protein, plus organic coconut sugar, raw cacao and banana, 33Fuel's Premium Protein avoids the artificial ingredients often found in protein powders. Flavour-wise, it's rich in cacao with hints of malt and dried fruit.' Check out our full list of MH-approved vegan protein. £31.19 at 33Fuel Isolate vs Concentrate vs Casein: Which Should You Choose? According to nutritionist James Aikten, who manages product development for Crazy Nutrition, it depends on the person's goals, dietary preferences, and nutritional needs or restrictions. 'Whey protein isolate is more heavily processed and has more fats and lactose removed, so it has a higher protein percentage by weight. It is faster absorbed by the body, making it ideal post-workout, but it is also more expensive.' While whey protein concentrate is less processed, 'it still has some of its fats and lactose', he says. 'It's cheaper and slower release but ideal for general use, especially if cost is a concern and you can factor the extra fat and calories into your macros.' Casein protein, on the other hand, 'is slower to digest, so it is often used before bed or during other extended periods without food to allow a steady absorption of protein'. For general use, Aitken recommends whey protein concentrate due to its low price point and 'steady' release of protein. 'Pea protein is a good option if you require a plant-based protein,' he adds, 'as it contains all nine essential amino acids. Despite not being considered a complete protein due to lower levels of lysine, some might also opt for rice protein. Mixing pea and rice protein can yield a fuller amino acid profile.' How Much Protein Do You Need? This is one of the most commonly asked questions about protein powder. Fleming stresses the importance of having a consistent daily intake of protein. 'Before relying solely on a supplement, try to ensure you're consuming 1.5-2g per kg of bodyweight regularly,' he says. 'This is going to help you much more than just consuming one shake a day, for example.' From there you can decide how much to consume. 'If you're slightly under this then a protein powder will be a perfect addition to help,' he adds.' Most powders will come with a scoop providing around 20-30g of protein. For smaller individuals, one scoop with water or milk will be more than sufficient. For larger individuals, 1-2 scoops with water or milk will do fine. Remember that you can lean on milk such as semi-skimmed or soya (plant-based) to help add additional protein to your shake, if it's necessary.' So what happens if you consume too much? 'Whilst protein is essential for muscle repair, growth, and various bodily functions, excessive protein intake can cause kidney strain, especially in those with pre-existing kidney conditions,' says Aitken. 'You may also experience bloating and constipation.' When is the Best Time to Take Protein Powder? This can depend on the type of protein you're taking, but most, like whey, soy, pea and hemp 'will be best taken after training to elicit muscle protein synthesis', says Fleming. 'But that doesn't mean you have to rush to get them in.' There's no need for a mad rush, essentially. 'You can finish training, have a shower, then create your shake, if you prefer. In fact, if you wanted to sip your protein shake during training, this will be equally as beneficial in starting the recovery process as the amino acids will already be in your system.' Whatever works for you. Where you should be more particular about timings is with slower absorbing protein powders, such as casein, which are 'best taken before going a long period without eating as these assist more with reducing the amount of total body protein breakdown', says Fleming. 'This may be useful if optimising the amount of muscle you're carrying around is the priority.' 'Hard Gainers' Do you need a protein powder to provide your diet with more calories, or solely for protein content? 'Some powders are higher in calories and more suitable for 'hard gainers' or individuals with a higher energy expenditure,' says Fleming. 'For example, if you're a lean individual who burns a lot of calories but insists on building muscle, then a higher-calorie powder is likely the one for you.'Likewise, if you're just trying to top up your protein or are going for body recomposition (reduce fat & increase muscle simultaneously), then just a standard protein powder will be fine as you will want to eat the majority of your calories from your diet, since this will assist in keeping you satiated.' Who Should Avoid Protein Shakes? Protein powder is generally considered safe for most people, however, the following people should exercise caution or avoid its use altogether, says Aitken. 'Individuals with pre-existing kidney problems or a history of kidney disease should consult their doctor before using protein powder, as excessive protein intake may strain the kidneys more. 'Those with allergies or sensitivities to specific protein sources (e.g. milk or lactose, soy, peas, rice, etc.) should avoid protein powders containing those ingredients. 'Pregnant or breastfeeding women should consult their doctor before using any supplements, including protein powder.' Why Trust Us? At Men's Health, we're dedicated to discovering and recommending the best sports supplements and products for men via hands-on testing and in-depth research. Aside from constantly updating and adding to our ever-growing nutrition section, Men's Health also dedicates an annual Sports Nutrition Awards package where we break down the best products for men — ranging everywhere from protein powder to energy drinks. More Of Our Favourite Sports Supplements Best Whey Protein Powder | Best Vegan Protein Powder | Best Mass Gainers | Best Meal Replacement Shakes | Best Creatine Supplements | Best Protein Bars | Best Vegan Protein Bars | Best Pre-workout You Might Also Like The 23 Best Foods to Build Muscle 10 of the Best Waterproof Boots to Buy in 2019 6 Ways to Improve Your Mental Health
Yahoo
2 days ago
- Yahoo
5-Day High-Protein Meal Plan for Beginners, Created by a Dietitian
Reviewed by Dietitian Jessica Ball, M.S., RDAbout This Plan This 5-day plan is set at 1,800 calories, with modifications for 1,500 and 2,000 calories. Each day provides at least 80 grams of protein and 30 grams of fiber to support a well-balanced diet. This plan focuses on balanced meals with beginner-friendly recipes using quality protein- and fiber-rich enough protein each day is one of the best ways to feel full, energized and satisfied, and it doesn't have to be complicated. This five-day high-protein meal plan for beginners will help you enjoy balanced, nourishing meals without spending hours in the kitchen. Each day is set at 1,800 calories, with easy tweaks to make it 1,500 or 2,000 calories to fit your needs. You'll get at least 80 grams of protein and 30 grams of fiber daily to help you stay on track and feel your best. With super-simple recipes like one-skillet dinners, sheet-pan meals and quick microwaveable veggies and grains, this plan is perfect if you're just getting started or want more no-fuss, satisfying weeknight meal ideas. Let's get started! Meal Plan at a Glance Chia pudding/ Yogurt bowl Grain bowl Skillet pasta/ Ice cream Chia pudding/ Hard-boiled egg & nuts Skillet pasta & green beans One-pot shrimp & quinoa/ Ice cream Chia pudding/ Peppers & hummus Grain bowl/ Hard-boiled egg & nuts Edamame sauté/ Yogurt bowl Chia pudding/ Hard-boiled egg & nuts White bean salad/ Snack jar Stuffed peppers/ Dark chocolate Breakfast sandwich/ Snack jar White bean salad Salmon & vegetables/ Yogurt bowl Day 1 Breakfast (428 Calories) 1 serving High-Protein Blueberry & Peanut Butter Chia Pudding Morning Snack (196 Calories) 1 serving Yogurt with Blueberries and Honey Lunch (381 Calories) 1 serving Vegan Superfood Grain Bowls Dinner (437 Calories) 1 serving One-Skillet Cheesy Ground Chicken Pasta 1 serving Microwaved Fresh Green Beans Evening Snack (315 Calories) 1 serving 2-Ingredient Peanut Butter Banana Ice Cream Daily totals: 1,807 calories, 80 g fat, 97 g protein, 190 g carbohydrates, 46 g fiber, 1,125 mg sodium To make it 1,500 calories: Omit evening snack. To make it 2,000 calories: Add 1 cup steamed frozen edamame for an afternoon snack. Day 2 Breakfast (428 Calories) 1 serving High-Protein Blueberry & Peanut Butter Chia Pudding Morning Snack (181 Calories) 1 serving Hard-Boiled Egg & Almonds Lunch (437 Calories) 1 serving One-Skillet Cheesy Ground Chicken Pasta 1 serving Microwaved Fresh Green Beans Dinner (381 Calories) 1 serving One-Pot Garlicky Shrimp & Broccoli ¾ cup cooked quinoa Evening Snack (315 Calories) 1 serving 2-Ingredient Peanut Butter Banana Ice Cream Daily totals: 1,804 calories, 89 g fat, 100 g protein, 163 g carbohydrates, 40g fiber, 1,517 mg sodium To make it 1,500 calories: Omit evening snack. To make it 2,000 calories: Add 1 cup steamed frozen edamame for an afternoon snack. Day 3 Breakfast (428 Calories) 1 serving High-Protein Blueberry & Peanut Butter Chia Pudding Morning Snack (98 Calories) 1 cup sliced red bell pepper 2 tablespoons hummus Lunch (381 Calories) 1 serving Vegan Superfood Grain Bowls Afternoon Snack (181 Calories) 1 serving Hard-Boiled Egg & Almonds Dinner (471 Calories) 1 serving 3-Ingredient Teriyaki Edamame Sauté 1 cup cooked quinoa Evening Snack (196 Calories) 1 serving Yogurt with Blueberries and Honey Daily totals: 1,805 calories, 88 g fat, 102 g protein, 188 g carbohydrates, 50 g fiber, 1,684 mg sodium To make it 1,500 calories: Omit morning snack and afternoon snack. To make it 2,000 calories: Add 2 Tbsp. hummus (for a total of 4 Tbsp.) to morning snack and add 1 oz. dark chocolate (70%-85%) to evening snack. Day 4 Breakfast (428 Calories) 1 serving High-Protein Blueberry & Peanut Butter Chia Pudding Morning Snack (181 Calories) 1 serving Hard-Boiled Egg & Almonds Lunch (416 Calories) 1 serving High-Protein White Bean Salad with Feta & Lemon-Garlic Vinaigrette Afternoon Snack (168 Calories) 1 serving High-Fiber Guacamole Snack Jar Dinner (551 Calories) 1 serving Fajita-Inspired Chicken-Stuffed Peppers 1 serving Fresh Sweet Corn Salad Evening Snack (170 Calories) 1 oz. dark chocolate (70%-85%) Daily totals: 1,845 calories, 98 g fat, 85 g protein, 152 g carbohydrates, 46 g fiber, 1,237 mg sodium To make it 1,500 calories: Omit afternoon snack and evening snack. To make it 2,000 calories: Add 1 oz. whole-wheat crackers to afternoon snack and add 1 small banana to evening snack. Day 5 Breakfast (344 Calories) 1 serving Egg Salad English Muffin Sandwich Morning Snack (168 Calories) 1 serving High-Fiber Guacamole Snack Jar Lunch (416 Calories) 1 serving High-Protein White Bean Salad with Feta & Lemon-Garlic Vinaigrette Dinner (522 Calories) 1 serving Garlic Butter–Roasted Salmon with Potatoes & Asparagus Evening Snack (196 Calories) 1 serving Yogurt with Blueberries and Honey Daily totals: 1,794 calories, 96 g fat, 100 g protein, 142 g carbohydrates, 30 g fiber, 1,541 mg sodium To make it 1,500 calories: Swap breakfast sandwich for 1 serving Egg, Spinach & Cheddar Breakfast Sandwich and omit evening snack. To make it 2,000 calories: Add 1 cup edamame to morning snack and add ½ cup fresh raspberries to evening Ahead Tips Make a batch of High-Protein Blueberry & Peanut Butter Chia Pudding to have for breakfast on Days 1 through 4. Save a serving of One-Skillet Cheesy Ground Chicken Pasta and Microwaved Fresh Green Beans to enjoy for lunch on Day 2. Cook 2 cups quinoa to have for Days 2 and 3. Prep the Vegan Superfood Grain Bowls for lunch on Days 1 and 3. Prep the High-Protein White Bean Salad with Feta & Lemon-Garlic Vinaigrette for lunch on Days 4 and asked Questions Is it OK to mix and match meals if there's one I don't like? Yes! This meal plan is meant to serve as inspiration. It doesn't need to be followed exactly to reap the benefits. When choosing recipes, we made sure to check the calories, fiber, protein and sodium to align with the parameters of this plan and be within our sodium limits. If you're making a recipe swap, it may be helpful to choose a recipe with similar calories, fiber, protein and sodium levels. For more inspiration, check out some of our other delicious high-protein dinner recipes. Can I eat the same breakfast or lunch every day? Definitely, it's fine to eat the same breakfast or lunch every day. The breakfasts range from 368 to 428 calories while the lunches span 381 to 437 calories. These ranges are fairly close, though if you're closely monitoring your calories or other nutrients, like protein, you may want to adjust a snack or two. Why is there not a 1,200-calorie modification? We no longer provide modifications for 1,200-calorie days in our meal plans. The 2020-2025 Dietary Guidelines for Americans suggests that limiting calories to 1,200 per day is too low for most people to meet their nutritional needs, plus it's unsustainable for long-term health and well-being. Health Benefits of a High-Protein Diet Eating enough protein is one of the best ways to feel full and satisfied. When your meals are low in protein, you'll likely find yourself feeling hungry soon after eating and reaching for extra snacks throughout the day. Research shows that eating enough protein can help your body release appetite-regulating hormones, which keeps you feeling fuller for longer. Unfortunately, many people fall short. Studies suggest about 40% of Americans aren't meeting their daily protein needs. Adding more high-protein foods to your diet doesn't have to be complicated or high-cost. This plan makes it easy, with beginner-friendly ideas like canned beans, edamame, eggs, yogurt and other budget-friendly proteins that require little to no prep. Since they're packed with plenty of fiber-rich ingredients, the meals in this plan can help slow down digestion and support healthy blood sugar levels. Together, this protein-and-fiber combo will help you feel your best while keeping meals simple and We Create Meal Plans Registered dietitians thoughtfully create EatingWell's meal plans to be easy-to-follow and delicious. Each meal plan meets specific parameters depending on the health condition and/or lifestyle goal it is targeting and is analyzed for accuracy using the nutrition database, ESHA Food Processor. As nutritional needs differ from person to person, we encourage you to use these plans as inspiration and adjust as you see the original article on EATINGWELL
Business Wire
2 days ago
- Business Wire
Sarepta Therapeutics Provides Statement on ELEVIDYS
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today issued the following statement: Shortly after 2:30 p.m. ET today, Sarepta received an informal request from the U.S. Food and Drug Administration (FDA) to voluntarily halt shipment of ELEVIDYS (delandistrogene moxeparvovec), our gene therapy for Duchenne muscular dystrophy (Duchenne), in the U.S. We first heard of this potential request earlier in the day at the same time the public and our patient communities did, through media reports. At Sarepta, patient safety and well-being are always our top priority. We are committed to upholding the highest safety standards for all of our therapies. This guides every decision we make, as evidenced by our conservative decision to pause shipments of ELEVIDYS for non-ambulant patients while we work with the FDA to update the label and evaluate the use of an enhanced immunosuppression regimen to mitigate the risk of acute liver failure. Based on our comprehensive scientific interpretation of the data, which shows no new or changed safety signals in the ambulant patient population, we will continue to ship ELEVIDYS to the ambulant population. We look forward to continued discussions and sharing of information with FDA in order to advance our shared purpose of protecting patient safety and informed access to care. We recognize that the death of any patient is heartbreaking, including the recent death of a 51-year-old non-ambulant Limb-Girdle Muscular Dystrophy (LGMD) patient. We also want to clarify that this tragic event occurred in a Phase 1 clinical trial for an investigational gene therapy called SRP-9004. SRP-9004 is a clinical stage therapy that is intended to treat a different disease (LGMD Type 2D), is administered using a different dose, and is manufactured using a different process. The LGMD study participant who passed away was not treated with ELEVIDYS, and the dosing for the SRP-9004 trial had concluded at the time of his death. Additionally, in a timely manner, Sarepta reported this ALF event as a life-threatening case to FDA on June 20, 2025, and further followed up with notification to FDA of the death on July 3, 2025, in accordance with applicable law and our commitment to full regulatory transparency. ELEVIDYS is the only approved gene therapy for individuals devastated by Duchenne, a rare, progressive and ultimately fatal disease. We are committed to working closely with the FDA to ensure that all decisions are grounded in science and the best interests of patients, considering the compelling need of these families to access disease-modifying therapy. About ELEVIDYS (delandistrogene moxeparvovec-rokl) ELEVIDYS (delandistrogene moxeparvovec-rokl) is a single-dose, adeno-associated virus (AAV)-based gene transfer therapy for intravenous infusion designed to address the underlying genetic cause of Duchenne muscular dystrophy – mutations or changes in the DMD gene that result in the lack of dystrophin protein – through the delivery of a transgene that codes for the targeted production of ELEVIDYS micro-dystrophin in skeletal muscle. ELEVIDYS is indicated for the treatment of Duchenne muscular dystrophy (DMD) in individuals at least 4 years of age. For patients who are ambulatory and have a confirmed mutation in the DMD gene For patients who are non-ambulatory and have a confirmed mutation in the DMD gene. The DMD indication in non-ambulatory patients is approved under accelerated approval based on expression of ELEVIDYS micro-dystrophin in skeletal muscle. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). IMPORTANT SAFETY INFORMATION CONTRAINDICATION: ELEVIDYS is contraindicated in patients with any deletion in exon 8 and/or exon 9 in the DMD gene. WARNINGS AND PRECAUTIONS: Infusion-related Reactions: Infusion-related reactions, including hypersensitivity reactions and anaphylaxis, have occurred during or up to several hours following ELEVIDYS administration. Closely monitor patients during administration and for at least 3 hours after the end of infusion. If symptoms of infusion-related reactions occur, slow, or stop the infusion and give appropriate treatment. Once symptoms resolve, the infusion may be restarted at a lower rate. ELEVIDYS should be administered in a setting where treatment for infusion-related reactions is immediately available. Discontinue infusion for anaphylaxis. Acute Serious Liver Injury: Acute serious liver injury has been observed with ELEVIDYS, and administration may result in elevations of liver enzymes (such as GGT, GLDH, ALT, AST) or total bilirubin, typically seen within 8 weeks. Patients with preexisting liver impairment, chronic hepatic condition, or acute liver disease (e.g., acute hepatic viral infection) may be at higher risk of acute serious liver injury. Postpone ELEVIDYS administration in patients with acute liver disease until resolved or controlled. Prior to ELEVIDYS administration, perform liver enzyme test and monitor liver function (clinical exam, GGT, and total bilirubin) weekly for the first 3 months following ELEVIDYS infusion. Continue monitoring if clinically indicated, until results are unremarkable (normal clinical exam, GGT, and total bilirubin levels return to near baseline levels). Systemic corticosteroid treatment is recommended for patients before and after ELEVIDYS infusion. Adjust corticosteroid regimen when indicated. If acute serious liver injury is suspected, consultation with a specialist is recommended. Immune-mediated Myositis: In clinical trials, immune-mediated myositis has been observed approximately 1 month following ELEVIDYS infusion in patients with deletion mutations involving exon 8 and/or exon 9 in the DMD gene. Symptoms of severe muscle weakness, including dysphagia, dyspnea, and hypophonia, were observed. Limited data are available for ELEVIDYS treatment in patients with mutations in the DMD gene in exons 1 to 17 and/or exons 59 to 71. Patients with deletions in these regions may be at risk for a severe immune-mediated myositis reaction. Advise patients to contact a physician immediately if they experience any unexplained increased muscle pain, tenderness, or weakness, including dysphagia, dyspnea, or hypophonia, as these may be symptoms of myositis. Consider additional immunomodulatory treatment (immunosuppressants [e.g., calcineurin-inhibitor] in addition to corticosteroids) based on patient's clinical presentation and medical history if these symptoms occur. Myocarditis: Acute serious myocarditis and troponin-I elevations have been observed following ELEVIDYS infusion in clinical trials. If a patient experiences myocarditis, those with pre-existing left ventricle ejection fraction (LVEF) impairment may be at higher risk of adverse outcomes. Monitor troponin-I before ELEVIDYS infusion and weekly for the first month following infusion and continue monitoring if clinically indicated. More frequent monitoring may be warranted in the presence of cardiac symptoms, such as chest pain or shortness of breath. Advise patients to contact a physician immediately if they experience cardiac symptoms. Preexisting Immunity against AAVrh74: In AAV-vector based gene therapies, preexisting anti-AAV antibodies may impede transgene expression at desired therapeutic levels. Following treatment with ELEVIDYS, all patients developed anti-AAVrh74 antibodies. Perform baseline testing for presence of anti-AAVrh74 total binding antibodies prior to ELEVIDYS administration. ELEVIDYS administration is not recommended in patients with elevated anti-AAVrh74 total binding antibody titers greater than or equal to 1:400. Adverse Reactions: The most common adverse reactions (incidence ≥5%) reported in clinical studies were vomiting, nausea, liver injury, pyrexia, and thrombocytopenia. Report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. You may also report side effects to Sarepta Therapeutics at 1-888-SAREPTA (1-888-727-3782). For further information, please see the full Prescribing Information. About Sarepta Therapeutics Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. For more information, please visit or follow us on LinkedIn, X, Instagram and Facebook. Forward-Looking Statements This statement contains 'forward-looking statements.' Any statements that are not statements of historical fact may be deemed to be forward-looking statements. Words such as 'believe,' 'anticipate,' 'plan,' 'expect,' 'will,' 'may,' 'intend,' 'prepare,' 'look,' 'potential,' 'possible' and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements relating to our future operations, research and development programs, clinical trials, ELEVIDYS, and expected plans, including our plan to continue to ship ELEVIDYS to the ambulant population and continued discussions and sharing of information with FDA in order to advance our shared purpose of protecting patient safety and informed access to care. Actual results could materially differ from those stated or implied by these forward-looking statements as a result of such risks and uncertainties. Known risk factors include the following: our products or product candidates may be perceived as insufficiently effective, unsafe or may result in unforeseen adverse events; our products or product candidates may cause undesirable side effects that result in significant negative consequences following any marketing approval; different methodologies, assumptions and applications we use to assess particular safety or efficacy parameters may yield different statistical results, and even if we believe the data collected from clinical trials are positive, these data may not be sufficient to support approval by the FDA or other global regulatory authorities; success in clinical trials, especially if based on a small patient sample, does not ensure that later clinical trials will be successful, and the results of future research may not be consistent with past positive results or with advisory committee recommendations, or may fail to meet regulatory approval requirements for the safety and efficacy of product candidates; we may not be able to comply with all FDA requests in a timely manner or at all; the possible impact of regulations and regulatory decisions by the FDA and other regulatory agencies on our business; and those risks identified under the heading 'Risk Factors' in our most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company, which you are encouraged to review. Any of the foregoing risks could materially and adversely affect the Company's business, results of operations and the trading price of Sarepta's common stock. For a detailed description of risks and uncertainties Sarepta faces, you are encouraged to review the SEC filings made by Sarepta. We caution investors not to place considerable reliance on the forward-looking statements contained herein. Sarepta does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof, except as required by law. Internet Posting of Information We routinely post information that may be important to investors in the 'For Investors' section of our website at We encourage investors and potential investors to consult our website regularly for important information about us. Source: Sarepta Therapeutics, Inc.
