The Medicines Company Reports Data on IV Antihypertensive

The Medicines Company presented favorable findings on its investigational drug Cleviprex compared with current intravenous (IV) antihypertensive agents in controlling perioperative hypertension at the 56th Annual Scientific Session of the American College of Cardiology. The findings were from ECLIPSE, the largest safety program to date comparing intravenous antihypertensive therapies, according to the company.

"Given the trial successfully met all of its primary endpoints, this marks the completion of our Phase III efforts for Cleviprex," John Kelley, president and chief operating officer, said. "The Medicines Company remains committed and on track to expeditiously move forward with [a new drug application] submission before the end of June."

The ECLIPSE program included a total of 1,964 cardiac surgery patients enrolled in three randomized, open-label trials comparing Cleviprex (clevidipine) with current intravenous antihypertensive agents: nitroglycerin, sodium nitroprusside or nicardipine. Beginning just before surgery, investigators monitored patients' blood pressure (BP) and administered the assigned antihypertensive agent, at their discretion, if BP became too high. Based on each patient's BP response for 24 hours after initiating the therapy, investigators determined BP excursions -- how much and how long systolic BP went above or below predefined, acceptable perioperative BP ranges.

The ECLIPSE analysis evaluated BP excursions from data pooled from all three studies and from the individual studies. In the pooled analysis, for the widest predefined acceptable perioperative BP range of 75145 mm Hg pre- and post-operatively and 65135 mm Hg during surgery, Cleviprex resulted in approximately half the BP excursion compared with the other agents. Results for the narrowest BP range of 105145 mm Hg pre- and post-operatively and 95135 mm Hg during surgery also favored Cleviprex.

Cleviprex is the first third-generation dihydropyridine calcium-channel blocker that acts rapidly and reliably, according to the company. It is vascular- and arterial-selective, and has an ultrashort half-life.