J Med Assoc Thai 2019; 102 (12):1289-95

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Comparing the Efficacy of Nidepine and Cardepine in Lowering Blood Pressure after Cardio-Aortic Surgery: A Randomized, Double-Blinded Controlled Trial
Ekkarat P , Sangkhathat S , Namchaisiri J Mail

Background: Parenteral nicardipine is an effective calcium channel blocker for blood pressure control during the post-cardioaortic surgical period.

Objective: To compare two preparations of nicardipine hydrochloride, Nidepine, and Cardepine, as a single treatment for acute hypertension after cardioaortic surgery in adult patients.

Materials and Methods: The study was a prospective randomized double-blinded controlled trial of 50 post-cardioaortic surgery patients with a systolic pressure greater than 140 mmHg that were divided into two groups. The first group received Nidepine at the initial dose of 1 mg per hour and titrated every 15 minutes until reaching the target blood pressure, while the other group received Cardepine at the same dose. The primary outcome was blood pressure reduction at 15 and 30 minutes of treatment.

Results: The blood pressures in both groups were significantly reduced within 15 minutes with 40% of the cases reaching the target of systolic pressure lower than 140 mmHg at 30 minutes. Systolic pressure reduction at 15 minutes in the Nidepine group (7.45% of baseline) was not significantly different from that of the Cardepine (5.04% of baseline) group. The mean arterial pressure reductions in both groups (6.42% and 6.99% of baseline in the Nidepine group and Cardepine groups, respectively) were comparable. There were no significant differences in total drug use in 24 hours (16.3 and 23.8 mg, respectively). The average duration of therapy was 22.8 hours in the Nidepine group, and 25.3 hours in the Cardepine group. Resumption of medication after cessation of treatment was required in two cases (8%) in the Nidepine group and three cases (12%) in the Cardepine group. There were no statistically significant differences between the groups in overall complication rates.

Conclusion: Nidepine is therapeutically equivalent to Cardepine in lowering blood pressure in acute hypertension following cardioaortic surgery. Trial registration: Thai Clinical Trials Registry, TCTR20190206003

Keywords: Hypertension, Cardiac surgery, Calcium channel blocker, Nicardepine

Received 20 Mar 2019 | Revised 13 Aug 2019 | Accepted 16 Aug 2019

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