Key result
The cyclodextrin formulation of intravenous amiodarone resulted in a statistically significant difference in mean arterial pressure compared to the polysorbate 80/benzyl alcohol formulation (P<0.001).
Why the study?
Does intravenous amiodarone containing cyclodextrin reduce hypotensive effects compared to the polysorbate 80/benzyl alcohol formulation in patients requiring IV amiodarone?
Cohort (n=160)
No
Does intravenous amiodarone containing cyclodextrin reduce hypotensive effects compared to the polysorbate 80/benzyl alcohol formulation in patients requiring IV amiodarone?
p-value: p=< 0.001
The cyclodextrin formulation of intravenous amiodarone is associated with less hypotension and a reduced need for fluid boluses compared to the older polysorbate 80/benzyl alcohol formulation during maintenance infusion.
Cyclodextrin formulation was associated with less hypotension; hypothesis-generating and requires randomized confirmation.
BACKGROUND: Two of the excipients in intravenous formulations of amiodarone, polysorbate 80 and benzyl alcohol, have been shown to cause hypotension. A newer formulation of amiodarone, which contains cyclodextrin, is devoid of these excipients. OBJECTIVE: To evaluate the change in mean arterial pressure when utilizing 2 intravenous amiodarone formulations. METHODS: This was a retrospective cohort analysis conducted at an academic medical center. Patients received intravenous amiodarone containing either polysorbate 80/benzyl alcohol (control) or cyclodextrin (cyclodextrin). Patients received these formulations based on a standard institutional protocol of 1 mg/min for 6 hours, followed by 0.5 mg/min for at least 18 hours or until discontinued by the provider. All data were collected from the medical record and included changes in blood pressures, time to lowest systolic blood pressure, concurrent antihypertensive use, and number of patients requiring treatment for hypotension. RESULTS: A total of 160 patients (120 control, 40 cyclodextrin) were included. There was a statistically significant difference in mean arterial pressure between the groups receiving the control formulation of amiodarone compared with the cyclodextrin formulation across the 24-hour maintenance phase infusion (P < 0.001). There was a significant difference between formulations with regard to the change in mean arterial pressure during the 0- to 6-hour and 12- to 18-hour time blocks. There was a statistically significant difference in the number of patients receiving fluid boluses for treatment of hypotension (P = 0.001). CONCLUSIONS: The excipients in the formulation of intravenous amiodarone may have a significant role in the hypotensive effects seen throughout the duration the maintenance phase infusion.
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Lindquist et al. (2015) conducted a cohort in Patients requiring intravenous amiodarone (n=160). Intravenous amiodarone containing cyclodextrin vs. Intravenous amiodarone containing polysorbate 80/benzyl alcohol was evaluated on Change in mean arterial pressure across the 24-hour maintenance phase infusion (p=< 0.001). The cyclodextrin formulation of intravenous amiodarone resulted in a statistically significant difference in mean arterial pressure compared to the polysorbate 80/benzyl alcohol formulation (P<0.001).
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