Intravenous nicardipine and labetalol use in hypertensive patients with signs or symptoms suggestive of end-organ damage in the emergency department: a subgroup analysis of the CLUE trial

OBJECTIVE: To compare the efficacy of Food and Drug Administration recommended dosing of nicardipine versus labetalol for the management of hypertensive patients with signs and/or symptoms (S/S) suggestive of end-organ damage (EOD). DESIGN: Secondary analysis of the multicentre prospective, randomised CLUE trial. SETTING: 13 academic emergency departments in the USA. PARTICIPANTS: Eligible patients had two systolic blood pressure (SBP) measures ≥180 mm Hg at least 10 min apart, no contraindications to nicardipine or labetalol and predefined S/S suggestive of EOD on arrival. INTERVENTIONS: Medications were administered by continuous infusion (nicardipine) or repeat intravenous bolus (labetalol) for a study period of 30 min or until a specified target SBP ±20 mm Hg was achieved. PRIMARY OUTCOME MEASURE: Percentage of participants achieving a predefined target SBP range (TR) defined as an SBP within ±20 mm Hg as established by the treating physician. RESULTS: Of the 141 eligible patients, 49.6% received nicardipine, 51.7% were women and 81.6% were black. Mean age was 52.2±13.9 years. Median initial SBP did not differ in the nicardipine (210.5 (IQR 197–226) mm Hg) and labetalol (210 (200–226) mm Hg) groups (p=0.862). Nicardipine patients were more likely to have a history of diabetes (41.4% vs 25.7%, p=0.05) but there were no other historical, demographic or laboratory differences between groups. Within 30 min, nicardipine patients more often reached the target SBP range than those receiving labetalol (91.4% vs 76.1%, difference=15.3% (95% CI 3.5% to 27.3%); p=0.01). On multivariable modelling with adjustment for gender and clinical site, nicardipine patients were more likely to be in TR by 30 min than patients receiving labetalol (OR 3.65, 95% CI 1.31 to 10.18, C statistic=0.72). CONCLUSIONS: In the setting of hypertension with suspected EOD, patients treated with nicardipine are more likely to reach prespecified SBP targets within 30 min than patients receiving labetalol. CLINICAL TRIAL REGISTRATION: NCT00765648, clinicaltrials.gov