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Ready-to-use CARDENE® I.V. (nicardipine hydrochloride) in severe hypertension

CARDENE I.V. vs sodium nitroprusside for severe hypertension

An open-label, randomized, multicenter, parallel group study compared the efficacy and safety of CARDENE I.V. with that of intravenous sodium nitroprusside in patients with severe hypertension (SBP >200 mm Hg or DBP >120 mm Hg) (N=121).1

The study showed that CARDENE I.V. may be an alternative to sodium nitroprusside in severe hypertension.1

Percentages of Patients With Severe Hypertension Achieving Therapeutic Response*

98% of clinical study participants with severe hypertension achieved therapeutic response

Adapted from Neutel, 1994.
*Therapeutic response was defined as SBP ≤160 mm Hg or a decrease in SBP ≥50 mm Hg, or DBP ≤95 mm Hg or a decrease in DBP ≥25 mm Hg.

The study also showed that treatment with CARDENE I.V. was associated with fewer dose adjustments and low rates of hypotension.1

Dose Adjustments and Adverse Events1

P Value CARDENE I.V. (n=61) Sodium Nitroprusside (n=60)
Dose adjustments during titration (mean ± SD) <0.02 1.7 ± 0.3 3.3 ± 0.4
Dose adjustments per hour during maintenance (mean ± SD) <0.01 0.54 ± 0.06 1.49 ± 0.21
Adverse events >5% Patients Patients
(BP <100/50 mm Hg)
2 10
Dizziness (supine) 2 10
Nausea 4 8
Vomiting 1 7
Headache 11 20
Central nervous system 4 8
Cardiovascular 4 9

Adapted from Neutel, 1994
Adverse events occurring in >5% of patients in either group; a patient may have had more than 1 adverse event.

See Study Design2

  • Trial Title: A comparison of intravenous nicardipine and sodium nitroprusside in the immediate treatment of severe hypertension
  • Design: A phase IV, open-label, 4-center, randomized, parallel assignment safety and efficacy study that enrolled patients who presented to the emergency department with SBP ≥200 mm Hg or DBP ≥120 mm Hg on 3 readings (5 min apart)
  • Methods: The trial was conducted in 4 emergency departments. Sixty-one (61) patients were randomized to CARDENE I.V. and 60 patients to sodium nitroprusside
  • Primary Outcome Measure: The percentage of subjects who achieved a therapeutic response—either SBP of ≤160 mm Hg or decrease in SBP of ≥50 mm Hg, or DBP of ≤95 mm Hg or decrease in DBP of ≥25 mm Hg
  • Interventions: (A) CARDENE I.V.—5 mg/hr for 15 min, 7.5 mg/hr for 15 min, 10 mg/hr for 15 min, and 12.5 mg/hr for 15 min or (B) sodium nitroprusside—<0.5 µg/kg/min for 15 min, then increased by 0.5 to 1.5 µg/kg/min every 5 min to maximum dose of 10 µg/kg/min for 10 min
  • Patients: Mean age 52 years; 70% male; 65% African American; initial SBP 215 mm Hg and initial DBP 126 mm Hg (means)
  • Results: Ninety-eight percent (98%) of patients treated with CARDENE I.V. achieved the therapeutic response compared with 93% of patients receiving sodium nitroprusside. The effects of the 2 drugs on SBP and DBP were not significantly different from each other. The mean number of dose adjustments was significantly lower for CARDENE I.V. treatment vs sodium nitroprusside treatment
  • Safety: Compared with the CARDENE I.V. group, patients receiving sodium nitroprusside experienced significantly more hypotension, dizziness, nausea, and vomiting. Adverse events were reported by 38% of patients receiving CARDENE I.V. and 56% of patients treated with sodium nitroprusside
  • Limitations: This study was not blinded and was not adequately powered to detect either superiority or noninferiority of CARDENE I.V. when compared with sodium nitroprusside

CARDENE I.V. vs placebo in severe hypertension

CARDENE I.V. effectively and safely controlled blood pressure in patients with severe hypertension (SBP >200 mm Hg or DBP >120 mm Hg) in a double-blind, placebo-controlled, multicenter trial (N=123).2

Rapid postoperative BP control in 11.5 minutesIn this study, which included patients with and without end-organ damage, 92% (67/73) of patients who received CARDENE I.V. achieved a therapeutic response (SBP ≤160 mm Hg or DBP ≤95 mm Hg). The mean time to therapeutic response was 77 ± 5.2 minutes. The mean dose required was 8.7 ± 0.3 mg/hr. There were no therapeutic responders in the placebo group (n=50). The difference between groups was statistically significant (P<0.0001).2



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