The FDA has approved Rapiblyk, a new drug to treat irregular heartbeats in critically ill hospitalized patients with severe supraventricular tachycardia (SVT), including atrial fibrillation and atrial flutter. Rapiblyk is designed as a fast-acting drug that rapidly lowers the heart rate during emergencies and in critical care settings, such as in the intensive care unit, the cardiac critical care unit, and in the operating room.
SVT causes abnormally fast heart rhythms in the upper chambers (atria), with or without heart disease. Atrial fibrillation (an irregular, rapid heartbeat) and atrial flutter (a fast, regular heartbeat) are similar but have unique risks. These conditions can last from days to years, impact heart function, and may need urgent care to prevent complications like heart failure or stroke.
Rapiblyk, the brand name for landiolol, is an injectable drug that slows the heart rate by blocking adrenaline's action on beta-1 receptors in the heart. Its precise, short-term effect makes it good for quickly lowering heart rate with minimal impact on blood pressure and other body functions.
In five clinical trials involving 317 patients with SVT, Rapiblyk reduced heart rate in 40% to 90% of them within about 10 minutes, compared to a placebo that reduced heart rate in 0%-11% of them. The most common side effect was low blood pressure, which occurred in about 10% of patients treated with Rapiblyk, versus 1% of those given the placebo.
Patients with certain health conditions such as heart block, high blood pressure in the lungs, and heart failure or allergic conditions should not use Rapiblyk, according to a statement from AOP Health, the drug’s maker. Patients or their caregivers should tell doctors about patients’ medical history, particularly related to heart, diabetes, or thyroid issues. As Rapiblyk is designed to provide short-term relief in emergencies and in critical care, it cannot be used for treating long-standing heart rhythm problems.