The association between antenatal indomethacin exposure and persistent pulmonary hypertension of the newborn in extremely preterm infants
Winrevair For Pulmonary Arterial Hypertension: What You Need To Know
Winrevair, also known as sotatercept-csrk, is a medicine used to treat pulmonary arterial hypertension (PAH), which causes high blood pressure in the arteries that go from your heart to your lungs.
Winrevair is available as an injection given by a health care provider or by you or your caregiver after getting trained on the injection technique.
Below you'll find common questions and answers about Winrevair.
Pulmonary arterial hypertension is categorized into groups by the World Health Organization based on the cause of the symptoms. Winrevair is approved for the treatment of people who have Group 1 pulmonary arterial hypertension, which is caused by narrowness, thickening, or stiffness in the arteries in the lungs.
Pulmonary arterial hypertension is also categorized by functional class based on the types of physical activity people are able to perform. These are known as functional classes and they include I, II, III, and IV.
In people with pulmonary arterial hypertension, there is high blood pressure in the arteries that go from your heart to your lungs. This can cause your heart to work harder to pump blood through the arteries, which can cause your heart to become weaker over time. Over time, this may cause heart failure. Winrevair is the first medicine in a new class of medicines used in people with pulmonary arterial hypertension. It can open up narrowed blood vessels, which can help blood flow through more easily. As a result, you may be able to exercise more or perform ordinary activities with less symptoms.
Winrevair is an injection given subcutaneously, meaning just below the skin. It comes in a kit that contains the medicine in the form of a powder, a prefilled syringe that contains sterile water for injection, and supplies needed to mix and give the injection.
Your health care provider may give this medicine to you, or it can be given by yourself or a caregiver. Your health care provider will determine which option is best. If you or a caregiver will be giving the medicine, you will be trained on the proper way to mix and give the medicine. Follow all instructions that your health care provider gives you.
You will need to have blood taken for some lab tests before you receive your first five doses, and occasionally after that. Your health care provider will decide when you need to have your blood tested.
You will receive or give yourself this medicine every three weeks. The dose is based on your weight and may also be based on the results of laboratory tests. It can be given in the stomach (at least 2 inches from your belly button), the upper thigh, or the upper arm. Your health care provider will decide how often you will get treatment and what the dose will be.
Winrevair was studied in a trial that included over 300 people who had pulmonary arterial hypertension that was classified as Group 1, functional class II or III, by the World Health Organization. All people were receiving treatment for their pulmonary arterial hypertension for at least 90 days before starting the trial. They were allowed to continue this treatment during the trial. About half of the people in this trial received Winrevair and about half received a placebo injection, which did not contain any medicine.
The people who received Winrevair in this trial received 0.3 milligrams per kilogram of their weight for the first dose. Starting with the second dose, people received 0.7 milligrams per kilogram, which was continued unless the dose needed to be reduced.
The six-minute walk distance was used to determine the effects of Winrevair. This test measures how far you can walk in six minutes. This distance was measured for each person at the beginning of the trial and after 24 weeks to see if there was any improvement.
Here are some characteristics of people who participated in these studies.
People who were treated with Winrevair were able to walk about 34.4 more meters at the end of the 24-week trial compared to only 1 more meter for those who received the placebo injection.
The number of people who died or had a clinical worsening event was compared in this study. Clinical worsening event meant any symptom that led to patients becoming sicker, such as the need for a lung or heart transplant, the need for other medicines, the need for higher doses of medicine, hospitalization, surgery, or worsening of pulmonary arterial hypertension, for example.
The total number of people in this study who died or had at least one clinical worsening event was lower for people who received Winrevair than those who received the placebo injections. A total of nine people who received Winrevair died or experienced a clinical worsening event compared to 42 who received a placebo injection.
Two people died who were receiving Winrevair compared to seven who were receiving the placebo injections.
More people who received placebo injections had to add a new medicine or increase their dose compared to those who received Winrevair.
Placebo
Winrevair
10.6%
1.2%
More people who received a placebo had a hospital stay of at least a day for their pulmonary arterial hypertension compared to those who received Winrevair.
More people who received placebo had their pulmonary arterial hypertension get worse compared to those who received Winrevair.
Placebo
Winrevair
9.4%
2.5%
The most common side effects seen with Winrevair were headache, nosebleeds, rash, spider veins, diarrhea, dizziness, or skin redness.
To help prevent headaches, be sure to get enough sleep at night, exercise regularly, eat regular meals, drink plenty of water, and limit stress.
If you get a nosebleed, stay calm. Try not to lie down but lean a little forward to help keep the blood from draining down your throat. Pinch your nostrils to close them and hold for 5 to 10 minutes. You will need to breathe through your mouth. After the bleeding has stopped, gently blow your nose to remove any clots.
Compression stockings and physical exercise may help with spider veins. In addition, try not to stand or wear high heels for long periods of time. Elevate your legs when possible, and try not to cross them.
If you get diarrhea, you can try the BRAT diet – bananas, rice, applesauce and toast. Try to avoid foods that are spicy, fried, fatty, citrus, or vegetables that can cause gas (beans, cabbage, Brussels sprouts). Also avoid dairy and foods and drinks that are high in sugar or caffeine.
Contact your pharmacist or health care provider if you are experiencing dizziness. Be sure you are getting enough fluids and eating enough. Do not drive while you are feeling dizzy.
Winrevair may increase your hemoglobin levels or decrease your platelet levels. You may have to have your blood taken before your dose to measure your hemoglobin and platelets.
Winrevair may cause serious bleeding. Call your health care provider right away if you have any of the following signs of severe bleeding while taking Winrevair:
Do not take Winrevir if you are pregnant, as it can cause harm to a fetus. Talk to your health care provider if you are pregnant, planning to get pregnant, or become pregnant while using Winrevair. You should use effective birth control while taking Winrevair and for at least four months after your last dose.
Winrevair may affect your ability to get pregnant. Talk to your health care provider if this is an important concern for you.
These are not all of the possible side effects of Winrevair. Talk with your health care provider if you are having symptoms that bother you. If you experience anything that you think may be caused by Winrevair, you can also report side effects to the FDA at 800-FDA-1088 (800-332-1088).
Winrevair can be obtained from specialty pharmacies that will ship the medicine directly to you. The specialty pharmacy will work directly with you and your health care team. It is important to answer all calls that you receive from your specialty pharmacy.
There may be cost assistance to help you afford Winrevair. You may have options even if you do not have health insurance. The Merck Access Program provides insurance support during treatment and helps eligible people with financial assistance, if eligible. Your health care provider will help you get started. Call 888-637-2502 for more information.
Temple Health's Heart And Vascular Institute Reaches Specialty Milestone
Philadelphia-based Temple University Hospital has achieved twin milestones in the treatment of chronic thromboembolic pulmonary hypertension. Care teams from the Advanced Pulmonary Hypertension, Right Heart Failure and CTEPH program at Temple's Heart and Vascular Institute have completed their 500th pulmonary thromboendarterectomy and 500th balloon pulmonary angioplasty.
Temple University Hospital is home to the largest CTEPH center in the eastern U.S., with pulmonary thromboendarterectomies only performed at a handful of hospitals across the nation, according to an Aug. 21 news release from the health system.
CTEPH is a potentially fatal form of high blood pressure "in the circulation of the lungs resulting from a blood vessel that has been blocked by a prior pulmonary embolism," the release said.
Pulmonary thromboendarterectomy involves placing the patient on a heart-lung machine and cooling their body to 65 degrees to periodically pause circulation. Pulmonary angioplasty remains an option for patients who are not eligible for a pulmonary thromboendarterectomy.
Temple University Hospital's pulmonary thromboendarterectomy survival rate is 95%, according to the release.
Anjali Vaidya, MD, director of the Advanced Pulmonary Hypertension, Right Heart Failure and CTEPH program at Temple University Hospital shared more about the dual achievement with Becker's.
Editor's note: Responses have been lightly edited for clarity and length.
Question: What do these twin milestones reveal about Temple's efforts to build a nationally recognized center of excellence?
Dr. Anjali Vaidya: Temple Heart and Vascular has been committed to our goal of providing exceptional care to each individual patient. Our nationally recognized pulmonary hypertension center of excellence is a testament to years of specialized pulmonary hypertension careers with emphasis on advanced clinical care, scholarly innovation and vast educational outreach.
Q: What were the most critical decisions or investments that enabled Temple to become the largest CTEPH center in the Eastern U.S.?
AV: Our team's commitment to meticulous clinical care with exceptional outcomes, with interdisciplinary collaborations between cardiology and Dr. Yoshiya Toyoda's [MD, PhD] cardiovascular surgery team.
Q: What has been most important to sustaining the interdisciplinary model at Temple's pulmonary hypertension program?
AV: Our team works extremely well together across departments, all with a patient-centered approach. We learn from each other and grow our experiences in partnership across cardiology, cardiac surgery, interventional cardiology, anesthesiology, radiology and more. The collaborative model at Temple allows for the best patient experiences and outcomes.
Q: Looking ahead, what innovations or research directions will shape the next phase of the program?
AV: Our team is continuously innovating on the scholarly front, inspired by and building on our clinical experiences and incorporating novel therapeutic techniques. The integration of multimodality treatments for an individual patient's CTEPH management continues to evolve, and being at the forefront of this with colleagues around the world has been exceptionally rewarding and beneficial for our patients.
What Is Hypertension? How To Stay Healthy And Manage Your Blood Pressure
New guidelines from the American Heart Association and the American College of Cardiology emphasize the importance of staying active, reducing salt intake and managing stress to maintain a healthy blood pressure.
Heart disease remains the leading cause of death for people in the United States as well as Shelby County. High blood pressure increases the risk of heart disease.
"It's a huge problem in Shelby County," said Dr. Jeff Mullins, a physician with Methodist Le Bonheur Healthcare. "A southern diet tends to be high in saturated fats and salt, and those two substances in your diet can cause you to have high blood pressure."
Additionally, African Amercians are more prone to high blood pressure and kidney damage associated with the condition, Mullins said, although it's unclear why that is.
What is high blood pressure?High blood pressure, or hypertension, is defined as a persistent elevation of blood pressure caused when the muscle wall of an artery constricts, or hypertenses, increasing the pressure of "the fluid going through the pipes, so to speak, of the vessel," Mullins said.
Sources differ on what qualifies as high blood pressure. Mullins said anything beyond 140/90 is considered hypertensive, but The American Heart Association considers 130-139 over 80-89 as stage one hypertension.
High blood pressure can sometimes be genetic, but it often comes from a person's lifestyle, Mullins said. Obesity, diabeties, smoking, a high-salt diet and a sedentary lifestyle can all contribute to high blood pressure.
How to prevent or reduce high blood pressureThe key to reducing your blood pressure through your lifestyle is by exercising, Mullins said. A 30-minute walk a day is considered regular exercise by The American Heart Association, he said. Losing weight can also be an effective way to drop blood pressure.
Mullins said he reccomends hypertensive patients avoid exercising through weightlifting until their blood pressure is under control, because lifting can actually increase pressure and lead to complications like a ruptured artery for those with hypertension and a weak spot in an artery.
The updated guidelines from the AHA suggest Americans limit the amount of alcohol they consume to no more than two drinks a day for men and one drink a day for women. Guidelines also urge Americans to reduce their sodium intake to 2,300 mg or 2.3 grams per day with an ideal target of 1,500 mg or 1.5 grams per day. The majority of Americans' sodium intake comes from eating packaged and restaurant foods rather than adding salt to food they cook at home.
The AHA also suggests managing and reducing stress with exercise, meditation, breathing control or yoga, as well as following a heart-healthy eating pattern. For example, the DASH eating plan, which emphasizes reduced sodium intake and a diet high in vegetables, fruits, whole grains, legumes, nuts and seeds, and low-fat or nonfat dairy, and includes lean meats and poultry, fish and non-tropical oils.
In some cases, hypertension is genetic and can't be prevented, Mullins said.
Jack Armstrong covers breaking news and the environment for The Commercial Appeal. He can be reached at jack.Armstrong@commercialappeal.Com and followed on X @jca2902.
This article originally appeared on Memphis Commercial Appeal: High blood pressure treatments: Reduce sodium, alcohol intake
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