The Medicines Company reported that data from two post-hoc analyses of the ECLIPSE trial showed that use of Cleviprex, an 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, according to the Vancouver, British Columbia-based company.
In the first analysis, the company said investigators examined the relationship between perioperative blood pressure (BP) control and postoperative MI in the 30-day postoperative period. In the second analysis, investigators evaluated 30-day mortality in patients who received IV antihypertensive therapy for BP control before cardiac surgery (282 patients).
ECLIPSE is a safety trial, comparing three IV 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, the Medicines Company said.
“Perioperative hypertension is recognized as a risk factor in cardiac surgery patients; however, its contribution to cardiac complications such as postoperative MI is unclear,” said lead investigator Edwin Avery, MD, Massachusetts General Hospital in Boston. “These new data suggest the critical importance of controlling blood pressure in this setting.”
Of the 282 patients in the first analysis, overall 30-day mortality was 5 percent, with a significant difference between groups: 3/137 (2 percent) of Cleviprex patients and 11/145 (8 percent) of nitroglycerin or sodium nitroprusside patients, the company said. The researchers concluded that in patients requiring pre-incision treatment for BP that Cleviprex was associated with significantly reduced risk of 30-day mortality after surgery compared to either sodium nitroprusside or nitroglycerin.
For the second analysis investigating the relationship between perioperative hypertension and 30-day postoperative MI, researchers calculated BP excursions in cardiac surgery patients during the first 24 hours after the perioperative use of either Cleviprex, or controlled therapy with sodium nitroprusside, nicardipine or nitroglycerin, Medicines Company said. BP control was quantified using the area under the curve method, capturing magnitude and duration of BP excursions outside predefined, systolic ranges.
Cleviprex was more effective at keeping patients’ BP within acceptable ranges than nitroglycerin and sodium nitroprusside. Cleviprex was equally as effective as nicardipine, according to the company. The researchers concluded that less precise BP control was an independent and significant predictor of an increased rate of MI within the 30-day postoperative period.