Results from the CLUE study, a head-to-head comparison between Ready-to-Use Cardene® I.V. (nicardipine) and labetalol in the emergency room, showed that Ready-to-Use Cardene I.V. lowers acutely elevated blood pressure more effectively than labetalol. These data were presented at the annual meeting of the American College of Emergency Physicians (ACEP) in Las Vegas, Nevada.

“The CLUE study is important for emergency room physicians because these findings demonstrate that using nicardipine instead of labetalol is more effective at controlling blood pressure in hypertensive patients”

“The CLUE study is important for emergency room physicians because these findings demonstrate that using nicardipine instead of labetalol is more effective at controlling blood pressure in hypertensive patients,” says Frank Peacock, M.D. of the Cleveland Clinic, the study’s lead investigator. “When physicians need to rapidly lower blood pressure, nicardipine is faster than labetalol. In this study, patients treated with nicardipine were approximately three times more likely to reach the target blood pressure range within 30 minutes than those treated with labetalol.”

A sudden, sustained rise in blood pressure is abnormal and may cause irreversible damage to the kidneys, heart, brain, or other organs. The longer the blood pressure remains high, the greater the risk of organ damage. It is believed that a rapid, smooth reduction of the elevated blood pressure to a target range may improve patient outcomes.1-4

A variety of agents may be used to treat high blood pressure in an emergency room setting. However, there have been few randomized studies comparing the relative benefits and risks of different antihypertensives, and there is little standardization of treatment regimens. Consequently, the choice of which agent to use in a particular patient may be determined by convenience alone. Only recently has nicardipine become available in Ready-to-Use bags which can be kept at the point-of-care and immediately available to treat the patient presenting with a hypertensive emergency.

“It is important to provide physicians with evidence-based guidance regarding the safe and effective lowering of blood pressure into a predefined target range,” says Graham May, M.D., Chief Medical Officer for EKR Therapeutics, the company that developed and markets Ready-to-Use Cardene® I.V. “This is especially true in the emergency room where prompt control of high blood pressure may reduce the severity of a heart attack or stroke.”

About the CLUE Study5

Methods: Eligible patients had to have two systolic blood pressure (BP) readings >180 mmHg measured at least 10 minutes apart, and no contraindications to either nicardipine (NIC) or labetalol (LAB). Before randomization, the emergency room physician specified a desired target systolic BP for the patient. This pressure ± 20 mmHg was called the Target Systolic Blood Pressure Range (TSBPR). NIC was started at an infusion rate of 5 mg/hr, and titrated upwards every five minutes by 2.5 mg/hr until the TSBPR was achieved, or a maximum rate of 15 mg/hr was reached; once in the target range, the NIC infusion rate was decreased to 3 mg/hr. LAB was first administered as a 20 mg bolus over two minutes, with 20, 40, or 80 mg boluses repeated every 10 minutes until the TSBPR was achieved, or a maximum of 300 mg had been given. The active treatment phase of the study was 30 minutes.

Results: CLUE enrolled 226 patients, 52.7% female, 76.4% African American, with a mean age of 52.6±14.6 y. On admission, 143 (63.3%) patients (NIC 71, LAB 72) had symptoms or signs suggesting end organ damage. There were no significant between-treatment differences in mean entry systolic BP (213.4±21.8 mmHg), diastolic BP (116.8±17.97 mmHg), demographic characteristics, or laboratory parameters, except that NIC patients were more likely to be diabetic (34.4% vs. 21.7%, p=0.032), or have hyperlipidemia (43.4% vs. 27.9%, p=0.017), and there were more past smokers [67.2% vs. 49.1%, p=0.006] and current smokers [42.2% vs. 27.3%, p=0.018] in the LAB group.

110 patients were randomized to NIC, 116 to LAB. After 30 minutes, more NIC than LAB patients had achieved the TSBPR (91.7 vs. 82.5%, p=0.039). BP was recorded every five minutes during the study period (a total of 6 measures) and more NIC than LAB patients had 5 and 6 readings within the TSBPR (47.3% vs. 32.8%, p=0.026). Adverse events were rare in either treatment group. The mean heart rate in LAB patients was slower than in NIC patients at all time points after the start of treatment (p