Evenity (romosozumab) is a medication prescribed for individuals with osteoporosis, a condition characterized by weakened bones and an increased risk of fractures. It aims to improve bone strength and reduce fracture incidence in postmenopausal women at high risk of breaks. It works through a unique mechanism, rapidly increasing bone density. However, it also carries specific cardiovascular safety concerns, highlighted by a boxed warning from regulatory bodies. Understanding these potential risks is important before initiating treatment.
Understanding Evenity
Evenity is an anabolic agent, promoting new bone formation. It is a humanized monoclonal antibody that targets and inhibits sclerostin, a protein naturally produced by bone cells that typically slows down bone building. By blocking sclerostin, Evenity enhances the activity of cells responsible for bone creation while also, to a lesser extent, reducing bone breakdown. The medication is administered as two subcutaneous injections once a month for a duration of 12 months.
Cardiovascular Considerations
Clinical trials have shown an increased risk of major adverse cardiovascular events (MACE) in patients treated with Evenity. MACE is a composite endpoint that includes myocardial infarction (heart attack), stroke, and cardiovascular death. The ARCH study, comparing Evenity to alendronate, showed a higher rate of MACE in the Evenity group. Specifically, 2.0% of women in the Evenity group experienced a MACE, compared to 1.1% in the alendronate group, over a 12-month period, including 16 heart attacks (0.8%) with Evenity versus 5 (0.2%) with alendronate, and 13 strokes (0.6%) versus 7 (0.3%). These events occurred in patients regardless of their prior history of heart attack or stroke.
Conversely, the FRAME trial, which compared Evenity to a placebo, found no similar MACE imbalance, with 0.8% of patients in both groups experiencing a MACE. This trial disparity has been a focus for regulators assessing the safety of this medication. Due to the ARCH study findings, the U.S. Food and Drug Administration (FDA) issued a boxed warning for Evenity, indicating an increased risk of heart attack, stroke, and cardiovascular death. It advises against initiating the medication in patients who have experienced a heart attack or stroke within the preceding year. Other regulatory bodies have also updated their product information to reflect these risks.
Risk Factors and Monitoring
Individuals considering Evenity require careful evaluation for pre-existing cardiovascular conditions. Healthcare providers must assess a patient’s overall cardiovascular risk profile, including factors like established cardiovascular disease, high blood pressure, high cholesterol, diabetes, smoking, severe kidney impairment, and age. The decision to use Evenity should weigh the potential benefits of fracture reduction against individual cardiovascular risks.
During treatment with Evenity, healthcare providers should remain vigilant for signs or symptoms of heart attack or stroke. Patients should seek immediate medical attention for symptoms like chest pain, shortness of breath, headache, vision changes, or difficulty speaking. If a patient develops a heart attack or stroke while on Evenity, the treatment should be discontinued. Ongoing cardiovascular monitoring, including blood pressure, may be implemented.
Patient-Provider Discussions
Open discussions with a healthcare provider are important before starting Evenity. Patients should provide a complete medical history, including any past or present cardiovascular conditions and all medications they are currently taking. This history allows accurate assessment of individual risks.
Patients should feel comfortable asking questions about the benefits of Evenity for their specific bone health needs versus the identified cardiovascular risks. Understanding how these factors apply to their personal situation is important for informed decision-making. Promptly reporting any new or worsening cardiovascular symptoms to the healthcare provider is also important during the course of treatment.