Clevidipine

Hypertensive crises require rapid blood pressure control to prevent stroke and myocardial injury. Despite Cleviprex's efficacy, its high cost limits accessibility in China. This Phase III, multicenter, randomized, double‐blind study evaluated the efficacy and safety of a generic clevidipine (China's first injectable generic clevidipine emulsion) versus the branded drug Cleviprex in managing hypertensive emergencies and urgencies among Chinese patients. A total of 377 patients of 33 medical centers from December 2021 to December 2022 were randomized, with 189 in the generic clevidipine group and 188 in the control. As a result, 95.6% of patients in the generic clevidipine group and 93.6% in the control achieved the target systolic blood pressure (SBP) reduction within 30 min (rate difference 0.020, 90% CI: −0.019 to 0.060). The mean area under the curve (AUC) of SBP outside the target range within the first hour was comparable between groups (329.8 ± 238.16 in generic clevidipine vs. 347.9 ± 302.79 in control). The median time to first achieve the target range within 30 min was 12.0 min in both groups. The proportion of patients successfully transitioning to oral therapy within 6 h was 93.4% in the generic clevidipine group and 93.6% in the control group. The incidence of drug‐related adverse events (AEs) was reported in 50 patients (27.3%) in the generic clevidipine group and in 48 (27.9%) in the control, with no unexpected safety signals. The generic clevidipine demonstrated comparable efficacy and safety to the branded drug, supporting its potential as an effective and accessible therapeutic alternative for acute hypertension management.Trial Registration : chinadrugtrials.org.cn identifier: ChiCTR20212877.

An 11-year-old, 8 kg, castrated male dog was presented for adrenalectomy, after being diagnosed with pheochromocytoma by identification of elevated urine metanephrines. Phenoxybenzamine was started 1 month before surgery (2 mg kg^-1, twice daily, orally). Anesthetic premedication was performed with methadone (0.5 mg kg^-1) intramuscularly and maropitant (1 mg kg^-1) subcutaneously. General anesthesia was induced with intravenous (IV) alfaxalone (1 mg kg^-1) and midazolam (0.3 mg kg^-1) and maintained with isoflurane in oxygen delivered through a circle breathing system. Dexmedetomidine (0.5 μg kg^-1 bolus over 5 minutes, followed by 0.5 μg kg^-1 hour^-1), magnesium sulfate (50 mg kg^-1 hour^-1 for the first hour, followed by 15 mg kg^-1 hour^-1) and lactated Ringer's solution (5 mL kg^-1 hour^-1) were given IV. Arterial blood pressures were measured invasively. During manipulation of the adrenal gland, systolic and mean arterial blood pressures increased to 240 and 150 mmHg, respectively, and heart rate decreased to 30 beats minute^-1. Clevidipine, a calcium channel blocker, was infused IV at 1-2 μg kg^-1 minute^-1, achieving a reduction in mean arterial blood pressure to between approximately 80 and 85 mmHg, with heart rate between 100 and 120 beats minute^-1. Recovery from anesthesia and surgery was uneventful. The dog was discharged from the hospital 3 days after surgery and its clinical status has been stable for 2 years after the procedure. This case report describes the successful treatment of hypertension using clevidipine, a specific arterial vasodilator with fast onset and offset of action and a low incidence of adverse effects.