Clevidipine

Clevidipine emulsion injection is an ultra-short-acting, intravenous calcium-channel blocker that produces a rapid and transient antihypertensive effect.

This is a multicenter, randomized, single-blind, parallel, positive-controlled, noninferiority phase III clinical trial comparing the efficacy and safety of clevidipine and nicardipine in hypertensive emergencies. Participants were randomly assigned in a 1 : 1 ratio to the experimental group (clevidipine emulsion injection) or the positive-control group (nicardipine), and standard safety data were collected.

In the per-protocol set (PPS), the primary endpoint showed that 100.0% of patients in the clevidipine group achieved a 15–25% reduction in systolic blood pressure from baseline within 30 min after dosing, compared with 95.9% in the nicardipine group. The absolute difference between the two proportions was 4.1% [95% confidence interval (CI): 0.58, 7.62], with the lower bound exceeding the noninferiority margin of –10%. Secondary endpoints revealed that the median time to reach the target systolic blood pressure (defined as a 15–25% reduction from baseline) was 9.0 (9.0, 12.0) minutes for clevidipine versus 12.0 (12.0, 15.0) minutes for nicardipine, and the between-group difference was statistically significant ( P  < 0.0001). The proportions of patients who successfully transitioned to oral antihypertensive therapy within 6 h after study drug discontinuation were 96.83% for clevidipine and 95.90% for nicardipine, with no statistically significant difference ( P  = 0.7459). In the safety set (SS), the safety endpoint showed that the proportion of patients whose systolic blood pressure fell by >25% from baseline within 3 min after dosing was 0.00% for clevidipine and 0.79% for nicardipine, with no statistically significant difference ( P  = 0.4980). The overall incidence of adverse events was similar between clevidipine and nicardipine.

Clevidipine has similar therapeutic effects and safety compared with the nicardipine.

URL: https://www.clinicaltrials.gov; Unique identifier: NCT04670809.

Severe preeclampsia is a hypertensive disorder of pregnancy that poses significant risks to both maternal and fetal health. First-line antihypertensives such as labetalol, hydralazine, and nifedipine are widely used; however, alternative agents may be considered in refractory cases. Clevidipine, an ultrashort-acting intravenous dihydropyridine calcium channel blocker, offers rapid titratability and is used in critical care settings, although its use in pregnancy remains understudied. We present a case of successful clevidipine use in a patient with severe preeclampsia refractory to standard therapy, highlighting its potential role in obstetric hypertensive emergencies. Clevidipine was selected due to its rapid onset, short half-life, and capacity for precise, titratable blood pressure control. Additionally, its metabolism by blood and tissue esterases, independent of hepatic or renal function, makes clevidipine advantageous in preeclampsia, where hepatic and renal dysfunction are often part of the disease process. Its rapid titratability also allows prompt discontinuation following spinal anesthesia, preventing prolonged hypotension that may result from non-titratable agents.