CLUE: a randomized Comparative effectiveness trial of IV nicardipine versus Labetalol Use in the Emergency department.
Crit Care. 2011 Jun 27;15(3):R157
Authors: Peacock WF, Varon J, Baumann BM, Borczuk P, Cannon CM, Chandra A, Cline DM, Diercks DB, Hiestand B, Hsu A, Jois-Bilowich P, Kaminski B, Levy P, Nowak RM, Schrock JW
ABSTRACT: : (words 247) BACKGROUND: Our purpose was to compare the safety and efficacy of Food and Drug Administration recommended dosing of IV nicardipine vs. IV labetalol for the management of acute hypertension. METHODS: Multicenter randomized clinical trial. Eligible patients had 2 systolic blood pressure (SBP) measures [greater than or equal to]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. RESULTS: Of 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) CONCLUSION: Patients treated with nicardipine are more likely to reach the physician-specified SBP target range within 30 minutes than those treated with labetalol. Registered at ClinicalTrials.gov, with identifier is NCT00765648.
PMID: 21707983 [PubMed - as supplied by publisher]