The Medicines Company announced that data from two post-hoc analyses of the ECLIPSE trial showed that use of Cleviprex (clevidipine butyrate) injectable emulsion to control blood pressure during cardiac surgery may be associated with a reduced risk of heart attack compared to two of three currently used IV antihypertensive agents.
In a separate sub-analysis, Cleviprex was associated with a lower 30-day mortality compared to two nitrovasodilators.
The two sub-analyses from Eclipse were presented during a poster session held at the annual meeting of the Society of Cardiovascular Anaesthesiologists (SCA). In the first analysis, investigators examined the relationship between perioperative blood pressure control and postoperative myocardial infarction (MI) in the 30-day postoperative period. In the second analysis, investigators evaluated 30-day mortality in patients who received IV antihypertensive therapy for blood pressure control before cardiac surgery. Eclipse is a large safety trial which compared three intravenous antihypertensive therapies involving 1,964 cardiac surgery patients, each enrolled in one of three randomized, open-label trials which compared Cleviprex to nitroglycerin, sodium nitroprusside or nicardipine. Overall results were presented in March at the American College of Cardiology meeting.
"Perioperative hypertension is recognized as a risk factor in cardiac surgery patients; however, its contribution to cardiac complications such as postoperative myocardial infarction (MI) is unclear," said lead investigator Edwin Avery, MD, Massachusetts General Hospital, Boston, MA. "These new data suggest the critical importance of controlling blood pressure in this setting".
Researchers examined 30-day mortality among a subset of Eclipse patients who received an IV hypertensive for blood pressure control prior to surgery. Patients were randomized to receive Cleviprex, sodium nitroprusside or nitroglycerin. No patients received nicardipine prior to cardiac surgery; therefore, they were excluded from this analysis.
"This analysis points to potential difference in antihypertensive treatments options to manage hypertension before and during cardiac surgery, which needs to be confirmed with future studies," says lead investigator Solomon Aronson, MD, Duke University Medical Centre, Durham, North Carolina.
Cleviprex is a novel investigational IV antihypertensive for the treatment of acutely elevated blood pressure, when the use of oral therapy is not feasible or desirable.