Results show Cleviprex (clevidipine butyrate) injectable emulsion is safe and effective for managing blood pressure in patients undergoing cardiac surgery and provides more precise blood pressure control than three commonly used IV antihypertensives.
The Eclipse program enrolled 1,964 cardiac surgery patients in one of three randomized, open-label trials comparing Cleviprex to either nitroglycerin or sodium nitroprusside perioperatively, or nicardipine postoperatively. Regarding the primary safety outcome of death, myocardial infarction, stroke, or renal dysfunction at 30 days, there was equivalence among all drugs evaluated with the suggestion that Cleviprex was superior to sodium nitroprusside in mortality.
In addition, and potentially most importantly, the precision of BP control was also calculated for each patient – how much and for how long systolic BP went above or below predefined, acceptable perioperative BP ranges.
Cleviprex was more effective than both nitroglycerin (P =0.0006) and sodium nitroprusside (P =0.003) in maintaining BP within a pre-specified acceptable range. Cleviprex was equivalent to nicardipine in maintaining BP within the initial broad range, however, when the BP range was narrowed, Cleviprex was also significantly better than nicardipine in reducing excursions outside the more narrow range, the company said.
John Kelley, president and COO of The Medicines Company, said: “These important data from the Eclipse program clearly demonstrate the significant benefits of Cleviprex in cardiac surgery patients. With the recent nationwide launch of Cleviprex, hospitals now have access to therapy that should advance the management of blood pressure in surgical and critical care settings.”