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Epoprostenol Suitable For Treatment Of Severe Pulmonary Hypertension In Children
Cite this articleEpoprostenol suitable for treatment of severe pulmonary hypertension in children. Nat Rev Cardiol 4, 522 (2007). Https://doi.Org/10.1038/ncpcardio0955
Share this article Get shareable linkSotatercept's FDA Approval A New Chapter For Pulmonary Arterial Hypertension
The FDA approved sotatercept (Winrevair) for treating pulmonary arterial hypertension (PAH) in adults, Merck announced on Tuesday.
A novel activin signaling inhibitor, sotatercept is indicated to increase exercise capacity, improve World Health Organization (WHO) functional class, and reduce the risk of clinical worsening events for people with WHO group 1 pulmonary hypertension.
"Sotatercept added to background therapy has the potential to become a new standard of care option for patients with pulmonary arterial hypertension," said Aaron Waxman, MD, PhD, of Brigham and Women's Hospital in Boston, in the company's press release.
The activin signaling inhibitor works by targeting the pro-proliferative and anti-proliferative signaling associated with pulmonary arterial wall and right ventricular remodeling in PAH. The biologic is labeled for subcutaneous injection every 3 weeks.
"This approval is an important milestone, as it offers healthcare providers a novel therapeutic option that targets a new PAH treatment pathway," said Marc Humbert, MD, PhD, of the Université Paris-Saclay, who, along with Waxman, was an investigator on the randomized STELLAR trial that supported sotatercept's approval.
PAH is a rare progressive disorder characterized by the narrowing or blockage of small pulmonary arteries, causing elevated blood pressure in pulmonary circulation and extra effort for the heart to pump. PAH is associated with high morbidity and mortality despite existing endothelin receptor antagonist and phosphodiesterase-5 inhibitor therapies.
In the STELLAR trial, sotatercept improved exercise capacity for PAH patients on background therapy. Patients showed a placebo-adjusted 41-m improvement in 6-minute walk distance (6MWD) from baseline to week 24, as well as better odds of improvement in 6MWD, N-terminal pro-B-type natriuretic peptide, and WHO functional class (38.9% vs 10.1%, P<0.001).
Notably, patients in the sotatercept arm of the trial were much less likely to die or experience a clinical worsening event over a median 32.7 weeks (5.5% vs 26.3%, HR 0.16, 95% CI 0.08-0.35).
Merck said that due to the risks of erythrocytosis and severe thrombocytopenia, patients should have their hemoglobin and platelets monitored before each of their first five doses of sotatercept (monitoring for longer if values are unstable). Treatment should not be initiated if platelet count is <50,000/mm3. Other warnings and precautions in the labeling include serious bleeding, embryo-fetal toxicity, and impaired fertility.
According to the prescribing information, common adverse events associated with the drug in trials included nose bleeds, dizziness, headache, telangiectasia, diarrhea, rash, and erythema.
Merck said that sotatercept will be made available to specialty pharmacies by the end of April.
Nicole Lou is a reporter for MedPage Today, where she covers cardiology news and other developments in medicine. Follow
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How To Reverse Pulmonary Hypertension Naturally
Adopting healthy lifestyle behaviors may help lower blood pressure in your lungs and ease your symptoms. For example, you can try adjusting your diet, exercising more, and avoiding stimulants.
Pulmonary hypertension happens when blood pressure in the arteries supplying blood to your lungs is abnormally high. Over time, this can weaken your heart and lungs, leading to complications like trouble breathing and tiredness.
While there isn't a cure for the condition, medications, treatments, and lifestyle changes can help.
Read on to learn more about healthy lifestyle behaviors that can assist in managing your pulmonary hypertension.
Regular aerobic exercise can help you keep your heart healthy. This is especially important because keeping your heart and lungs functioning at their best can be difficult with pulmonary hypertension.
A 2021 study suggests that a supervised exercise-based rehabilitation program is generally safe for most people with pulmonary hypertension who are otherwise medically stable. It found that the program could increase their capacity to do more exercise.
The Pulmonary Hypertension Association recommends the following strategies when starting a new physical activity program:
Sodium is an electrolyte that your body needs to function properly. Consuming too much can make you retain large amounts of fluid, which can increase your blood pressure.
By reducing the sodium in your diet, you can help prevent your pulmonary hypertension from getting worse.
A 2018 study suggests that managing fluid retention is a key part of keeping pulmonary hypertension under control. If your fluid levels are too high, your doctor might recommend medications such as diuretics.
In addition to limiting your sodium intake, you should also make some careful dietary choices.
For example, you might want to make sure you're getting enough vitamin D and iron. A 2020 report found that people with pulmonary hypertension were more likely to be deficient in these nutrients. However, only a blood test can tell you actually have an iron or vitamin D deficiency.
Generally, a heart-healthy eating plan — such as the Mediterranean diet or the Dietary Approaches to Stop Hypertension (DASH) diet — will provide you with a range of healthy vitamins and minerals. Both diets emphasize fruits, vegetables, whole grains, healthy fats, and lean proteins.
If you have pulmonary hypertension, you might be taking medications that take extra stress off of your heart and lungs. However, it's important to be aware that not all over-the-counter medications are safe for you to take.
Decongestants and cold medicines can contain stimulants such as pseudoephedrine or ephedrine. You should either avoid these entirely or only take them if a doctor says it's OK.
Smoking is not only a major risk factor for developing pulmonary hypertension, but it's also a behavior that can make existing symptoms even worse. Second-hand smoke exposure is also dangerous.
If you need help quitting smoking, talk with your healthcare team about the latest in products and programs that may be helpful.
Even if you've tried to quit before but been unsuccessful, it's even more important to give it a try again if you have been diagnosed with pulmonary hypertension. You can also contact the tobacco quit line at 1-800-QUIT-NOW.
Poor sleep is associated with health problems like high blood pressure and obesity. You can improve your health by prioritizing sleep quality and quantity. Aim for 7–9 hours of sleep each night.
Some people with pulmonary hypertension also have a breathing condition called obstructive sleep apnea (OSA), which means you stop breathing during your sleep. If you have OSA, it's especially important to be aggressive and consistent in managing your pulmonary hypertension.
A 2021 study suggests that about 1 in 5 people with OSA have or develop pulmonary hypertension. Their outcomes tend to be worse than people with OSA and no pulmonary hypertension.
Certain external conditions can exacerbate pulmonary hypertension symptoms because they put strain on the heart and lungs. Therefore, you may need to avoid taking very hot baths or showers and steer clear of saunas and hot tubs.
In addition, spending time in high altitudes can tax the lungs and worsen pulmonary hypertension.
While natural treatments and healthy lifestyle changes may help improve your symptoms, they should not be viewed as replacements for evidence-based treatments.
If you have been diagnosed with pulmonary hypertension, be sure to discuss all treatment options and lifestyle adjustments you can make to reverse or at least better manage your symptoms.
It often takes a combination of approaches to control this serious cardiovascular condition.
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