A 48-hour infusion of CARDENE I.V. at 4 mg/hr produced decreases of 26 mmHg (17%) in systolic blood pressure and 20.7 mmHg (20%) in diastolic blood pressure in patients with mild to moderate hypertension.
RCT (n=244)
Double-blind
Yes
Does high-concentration intravenous nicardipine infusion (0.5 mg/mL) cause concentration-related adverse drug events in adult patients?
High-concentration intravenous nicardipine (0.5 mg/mL) appears safe for short-term treatment of hypertension in adults, with no infusion-related adverse events observed.
Purpose The purpose of this study was to evaluate the safety of high-concentration nicardipine, defined as a concentration of 0.5 mg/mL, in adult patients. Methods This was a retrospective, observational, single-center study conducted at a 576-bed academic medical center. Adult patients who received 0.5 mg/mL nicardipine between January 2014, and September 2024, were evaluated, excluding those on nicardipine for less than two hours. Data on demographics, clinical parameters, treatment details, and infusion specifications were extracted from the electronic medical record. Concentration-related adverse drug events (ADEs), including infusion site pain or reaction, erythema, extravasation, phlebitis, and irritation, were captured using chart search and incident reporting databases. Results Eighty-one patients were assessed and fifty-one were included. The median age was 55 41-64.5 years old and 70.6% were male. Primary indications for nicardipine included hypertension without organ damage (47.1%) and hypertensive emergency with evidence of new onset or worsening end-organ dysfunction (43.1%). Most patients were in the ICU (98%) at initiation, primarily in the neuroscience ICU (56.9%). The median initial infusion duration was 27.4 10.3-58.9 hours . No ADEs were observed in the study population. Conclusion The administration of nicardipine at a concentration of 0.5 mg/mL appears to be safe in adult patients, with no ADEs observed during the study period. Establishing the safety of high-concentration nicardipine in adults can have significant implications for the short-term treatment of hypertension, offering a low volume and cost-effective alternative. Further large-scale investigations are warranted to substantiate these results.
Lam et al. (Tue,) conducted a rct in Hypertension (n=244). CARDENE I.V. (nicardipine hydrochloride) vs. Placebo was evaluated on Decrease in systolic blood pressure. A 48-hour infusion of CARDENE I.V. at 4 mg/hr produced decreases of 26 mmHg (17%) in systolic blood pressure and 20.7 mmHg (20%) in diastolic blood pressure in patients with mild to moderate hypertension.
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