From the 56th Annual Scientific Session of the American College of Cardiology: ECLIPSE: Clevidipine offers promising perioperative blood pressure control in phase 3 trial

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In a phase 3 trial, the investigational dihydropyridine calcium antagonist clevidipine demonstrated less pronounced perioperative blood pressure excursions compared with other intravenous antihypertensive agents in patients undergoing cardiac surgery.

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In a phase 3 trial, the investigational dihydropyridine calcium antagonist clevidipine demonstrated less pronounced perioperative blood pressure excursions compared with other intravenous antihypertensive agents in patients undergoing cardiac surgery.

The results of the trial were presented at the 56th Annual Scientific Session of the American College of Cardiology (ACC).

The Evaluation of Clevidipine in the Postoperative Treatment of Hypertension Assessing Safety Events (ECLIPSE) study consisted of 3 open-label trials involving 1,964 cardiac surgery patients. In the studies, patients were randomized to clevidipine, nitroglycerin, sodium nitroprusside, or nicardipine. Patients' blood pressures were monitored beginning just before surgery, and the assigned antihypertensive drug was administered if blood pressure increases were deemed excessive.

For the widest predefined acceptable perioperative systolic blood pressure range (75–145 mmHg pre and postoperatively and 65–135 mmHg during surgery), clevidipine was associated with approximately half the blood pressure excursion associated with nitroglycerin (4.14 vs 8.87 mmHg•min/h, respectively; P=.0006); clevidipine also resulted in significantly less blood pressure excursion versus sodium nitroprusside (4.37 vs 10.50 mmHg•min/h, respectively; P=.0027); there was no significant difference in blood pressure excursions between clevidipine and nicardipine (1.76 vs 1.79 mmHg•min/h, respectively; P=.086), although this comparison was restricted to only the postoperative period.

For the narrowest predefined acceptable perioperative systolic blood pressure range (105–145 mmHg pre and postoperatively and 95–135 mmHg during surgery), clevidipine was superior to sodium nitroprusside in blood pressure excursion (100.17 vs 127.87 mmHg•min/h, respectively; P=.045); clevidipine resulted in a trend towards less excursion compared with nitroglycerin (83.74 vs 108.57 mmHg•min/h, respectively; P=.056).

The rates of the primary clinical end point (a composite of death, stroke, myocardial infarction [MI], and kidney dysfunction) were not significantly different with clevidipine versus its 3 comparators, although the rate of death was significantly lower with clevidipine compared with sodium nitroprusside (1.7% vs 4.7%, respectively; P=.045).

The researchers noted that another important finding from the ECLIPSE study was that tight blood pressure control during the 24-hour perioperative period was associated with lower 30-day mortality compared with wide blood pressure excursions. Thirty-day mortality was increased by 20% with blood pressure excursions >1 mmHg over a 60-minute time period, with the risk increasing with each additional 1-mmHg/min excursion outside the prespecified range. Mortality at 30 days was increased by 43% with a 2-mmHg/min variation from the target range over 60 minutes, 71% with a 3-mmHg/min variation, 105% with a 4-mmHg/min variation, and 146% with a 5-mmHg/min variation.

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