April 23, 2024

Cardiovascular Drug Approvals

Within the last month, three new cardiovascular drugs were approved by the FDA.

Tryvio™ (aprocitentan) tablets were approved for the treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in patients who are not adequately controlled on other drugs. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions.

Common adverse reactions for Tryvio included edema/fluid retention and anemia. Tryvio is contraindicated with pregnancy and hypersensitivity. As an endothelin receptor agonist (ERA), Tryvio can cause hepatoxicity and liver failure. Additionally, Tryvio may cause decreases in hemoglobin and sperm count.

Opsynvi® (macitentan and tadalafil) tablets are indicated for the chronic treatment of pulmonary arterial hypertension, reducing the risk of clinical worsening events and hospitalization, while also improving exercise ability.

Common adverse reactions for Opsynvi include edema/fluid retention and anemia. Opsynvi is contraindicated with pregnancy, hypersensitivity, concomitant organic nitrates, and concomitant GC stimulators. As an endothelin receptor agonist (ERA), Opsynvi can cause hepatoxicity and liver failure. Additionally, Opsynvi may cause hearing impairment, decreased sperm count, and sudden visual loss.

Winrevair (sotatercept-csrk) injections are indicated for the treatment of pulmonary arterial hypertension to increase exercise capacity and reduce the risk of clinical worsening events.

Common adverse reactions for Winrevair include headache, epistaxis (nosebleed), rash, telangiectasia (widened blood vessels on the skin), diarrhea, dizziness, and erythema (redness of the skin). Winrevair may also cause serious bleeding and impaired fertility.

While heart medications have seen limited utilization in workers’ comp, they are more common amongst firefighter populations.

According to NCCI, of the 38 jurisdictions they monitor, 19 offer presumptive coverage for heart and vascular conditions among firefighter populations, typically for hypertension and heart disease. However, there was significant complexity across legislation, as proving that these conditions were primarily brought about by occupational factors is difficult.

Regardless, some states have recently proposed expanded coverage for certain cardiovascular conditions among firefighters. For instance, New Jersey Assembly Bill 5909 has gone into effect, creating a workers’ comp presumption for emergency medical service (EMS) workers who suffer a stroke or heart attack if they happen shortly after they were on an emergency call. Maryland House Bill 1145 was also introduced, which would create a hypertension presumption for certain firefighters, fire-fighting instructors, rescue squad members, advance life support unit members, and members of the Office of the State Fire Marshall, if certain requirements are met.

For ongoing coverage of the latest drug approvals and alerts impacting workers’ comp, visit Med Monitor online.

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