were roughly equipotent with respect to systemic
arterial pressure, and there were only minor differences
in the use of open-label norepinephrine,
most of which were related to early termination
of the study drug and a shift to open-label norepinephrine
because of the occurrence of arrhythmias
that were difficult to control. Doses of openlabel
norepinephrine and the use of open-label
epinephrine and vasopressin were similar between
the two groups. Second, we used a sequential design,
which potentially allowed us to stop the
study early if an effect larger than that expected
from observational trials occurred; however, the
trial was eventually stopped after inclusion of more
patients than we had expected to be included on
the basis of our estimates of the sample size.
Accordingly, all conclusions related to the primary
outcome reached the predefined power.
In summary, although the rate of death did
not differ significantly between the group of patients
treated with dopamine and the group treated
with norepinephrine, this study raises serious concerns
about the safety of dopamine therapy, since
dopamine, as compared with norepinephrine, was
associated with more arrhythmias and with an
increased rate of death in the subgroup of patients
with cardiogenic shock.
were roughly equipotent with respect to systemicarterial pressure, and there were only minor differencesin the use of open-label norepinephrine,most of which were related to early terminationof the study drug and a shift to open-label norepinephrinebecause of the occurrence of arrhythmiasthat were difficult to control. Doses of openlabelnorepinephrine and the use of open-labelepinephrine and vasopressin were similar betweenthe two groups. Second, we used a sequential design,which potentially allowed us to stop thestudy early if an effect larger than that expectedfrom observational trials occurred; however, thetrial was eventually stopped after inclusion of morepatients than we had expected to be included onthe basis of our estimates of the sample size.Accordingly, all conclusions related to the primaryoutcome reached the predefined power.In summary, although the rate of death didnot differ significantly between the group of patientstreated with dopamine and the group treatedwith norepinephrine, this study raises serious concernsabout the safety of dopamine therapy, sincedopamine, as compared with norepinephrine, wasassociated with more arrhythmias and with anincreased rate of death in the subgroup of patientswith cardiogenic shock.
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