Abstract
This study evaluated the efficacy of intravenous (IV) calcium pretreatment for preventing diltiazem-induced hypotension and assessed its safety in adult patients with atrial fibrillation (AF)/atrial flutter (AFL) with rapid ventricular response (RVR). This randomized, double-blind, placebo-controlled trial included 217 adults with AF/AFL and a ventricular rate>120 beats per minute, who were randomized into three groups: those who received an IV NaCl 0.9% placebo pretreatment prior to IV diltiazem (PD; 73 patients) and those who received 90mg (C90D; 71 patients) and 180mg (C180D; 73 patients) IV calcium chloride pretreatment before IV diltiazem. We compared participants' systolic blood pressure (SBP) and heart rate (HR) at baseline and at 5, 10, and 15min post-treatment, as well as the incidence of adverse events (e.g., hypotension, urticaria, nausea) among the groups. The PD and C90D pretreatment groups had significantly lower HR measurements at 10 and 15min compared to the C180D group. In addition, at 5min, the mean SBP in the PD group was significantly lower compared to the C90D and C180D groups. At 10min, the mean SBP was significantly higher in the C180D group than in the other groups. Furthermore, at 15min, the mean SBP was significantly higher in both the C90D and C180D groups than in the PD group. There were no significant differences between the calcium pretreatment and placebo groups in terms of the need for additional diltiazem doses or the incidence of adverse events. IV calcium pretreatment effectively prevents diltiazem-induced hypotension in patients with AF/AFL with RVR without compromising the efficacy of diltiazem in achieving and maintaining ventricular rate control. National Library of Medicine Clinical Trial Registry; No.: NCT06494007; URL: https://clinicaltrials.gov/study/NCT06494007.
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