CLUE: a randomized comparative effectiveness trial of IV nicardipine versus labetalol use in the emergency department

Abstract

IntroductionOur purpose was to compare the safety and efficacy of food and drug administration (FDA) recommended dosing of IV nicardipine versus IV labetalol for the management of acute hypertension.MethodsMulticenter randomized clinical trial. Eligible patients had 2 systolic blood pressure (SBP) measures ≥180 mmHg and no contraindications to nicardipine or labetalol. Before randomization, the physician specified a target SBP ± 20 mmHg (the target range: TR). The primary endpoint was the percent of subjects meeting TR during the initial 30 minutes of treatment.ResultsOf 226 randomized patients, 110 received nicardipine and 116 labetalol. End organ damage preceded treatment in 143 (63.3%); 71 nicardipine and 72 labetalol patients. Median initial SBP was 212.5 (IQR 197, 230) and 212 mmHg (IQR 200,225) for nicardipine and labetalol patients (P = 0.68), respectively. Within 30 minutes, nicardipine patients more often reached TR than labetalol (91.7 vs. 82.5%, P = 0.039). Of 6 BP measures (taken every 5 minutes) during the study period, nicardipine patients had higher rates of five and six instances within TR than labetalol (47.3% vs. 32.8%, P = 0.026). Rescue medication need did not differ between nicardipine and labetalol (15.5 vs. 22.4%, P = 0.183). Labetalol patients had slower heart rates at all time points (P < 0.01). Multivariable modeling showed nicardipine patients were more likely in TR than labetalol patients at 30 minutes (OR 2.73, P = 0.028; C stat for model = 0.72)ConclusionsPatients treated with nicardipine are more likely to reach the physician-specified SBP target range within 30 minutes than those treated with labetalol.Trial registrationClinicalTrials.gov: NCT00765648

The Management of Acute Hypertension in Patients With Renal Dysfunction: Labetalol or Nicardipine?

“…All significant risk factors from the main CLUE manuscript were considered. 18 Nonetheless, because this is a subset of the CLUE study, all baseline variables with no more than 10% missing data points were evaluated for inclusion into an adjusted model. A P value of , 0.05 was considered as a significant risk factor and was included in the final model.…”

“…18 Informed consent was obtained from patients prior to initiation of any study-related activities. The trial was registered at ClinicalTrials.gov, with the identifier NCT00765648.…”

Cardiovascular Hypertensive Emergencies

“…However, drugs that increase cardiac work (i.e., hydralazine) or acutely decrease cardiac contractility (i.e., labetalol) should be avoided [33].…”

Control of hypertension in the critically ill: a pathophysiological approach

“…Its dosage is weight-independent, easily titrated, and it promotes cerebral and coronary vasodilation [41]. Nicardipine has been used for the treatment of severe hypertension, particularly in the perioperative period [42,43], and has recently been shown to be superior to labetalol in treating acute severe hypertension in emergency department patients [44], including those with end-organ damage [45], and also in critically ill patients [46]. …”