Frequency of "on-label" use of intravenous diltiazem for rate control in patients with acute-onset atrial fibrillation or atrial flutter.

ABSTRACT

PURPOSE: The study was designed to characterize "on-label" use of i.v. diltiazem in patients with acute atrial fibrillation or flutter (AFF). METHODS: An IRB-approved, single-center, retrospective, observational design was used. Eligible patients had acute AFF with heart rate >120 bpm and received i.v. diltiazem from June 1, 2012, to June 30, 2014. The primary outcome was frequency of on-label use of i.v. diltiazem, defined as use of at least one FDA-approved weight-based bolus dose followed by an infusion, if appropriate, in the absence of contraindications. RESULTS: A total of 300 patients were screened; 97 patients were included for analysis. I.V. diltiazem was used on-label in only 14 patients (14%). Of the 96 patients who received an initial diltiazem bolus injection, the median dose was significantly higher in patients for whom the diltiazem dose was on-label, as follows 17.5 mg (interquartile range [IQR]), 10-20 mg vs. 10.0 mg (IQR, 10-20 mg), p < 0.02). Twenty-nine patients (35%) in the off-label group had a therapeutic response to diltiazem alone compared with 8 patients (57%) in the on-label group (p = 0.11). More patients treated with off-label diltiazem bolus injection required additional rate control medications (41% vs. 7%, p < 0.04). CONCLUSION: In most patients, i.v. diltiazem was not used in accordance with FDA labeling. For most, i.v. diltiazem doses were lower than recommended and many of these patients required additional rate control medications to achieve a therapeutic response.