Discussion
In this study, the postoperative administration of vestipitant
wasno different fromondansetron 4mgi.v. in surgical patients
with PONV after failed ondansetron prophylaxis. This was observed
at all doses of i.v. vestipitant, ranging from 6 to 36 mg.
The primary endpoint for efficacy was the rate of patients exhibiting
complete response, defined as no emesis and no further
rescue medication from10 min post-infusion up to 24 h or hospital
discharge. The complete response rate for all doses of vestipitant
combined was 56% compared with ondansetron at
42%. However, vestipitant was superior to ondansetron in decreasing
the episodes of postoperative emesis and retching.
It should be noted that the patient population for this trial
was predominantly women. However, this limitation is a
logical consequence to the eligibility based on the Apfel risk
score15 reflecting the population most at risk for PONV.
However, there is no convincing evidence that the response
inmenwould be different with respect to antiemetic response.
The difference in response would most likely be due to the differences
in the control event rate in prevention studies.
The NNRS scores and the times to PONV or discharge were
similar between the vestipitant and ondansetron treatment
groups. In addition, administration of vestipitant andondansetron
in these surgical patients was safe and well tolerated with
a low number of adverse events.
Although several strategies are available for the prevention
of PONV, there are fewer effective treatment options after the
onset of PONV.16 17 This is primarily because of the difficulty
of conducting interventional trials for PONV. Owing to the
difficulty in predicting PONV after failed prophylaxis, these
studies require screening a large number of patients, of
which a small proportion may subsequently experience PONV
and become eligible for enrolment into an interventional
trial.16 17 Furthermore, the pharmacodynamic features of the
available preventive agents are different and some (such as the study by Kovac and colleagues, there is good reason to
assume that ondansetron in the study by Diemunsch and colleagues,
18 Candiotti and colleagues,10 and in the current study
had some effect and could have been better than placebo had
placebo been tested.4
DiscussionIn this study, the postoperative administration of vestipitantwasno different fromondansetron 4mgi.v. in surgical patientswith PONV after failed ondansetron prophylaxis. This was observedat all doses of i.v. vestipitant, ranging from 6 to 36 mg.The primary endpoint for efficacy was the rate of patients exhibitingcomplete response, defined as no emesis and no furtherrescue medication from10 min post-infusion up to 24 h or hospitaldischarge. The complete response rate for all doses of vestipitantcombined was 56% compared with ondansetron at42%. However, vestipitant was superior to ondansetron in decreasingthe episodes of postoperative emesis and retching.It should be noted that the patient population for this trialwas predominantly women. However, this limitation is alogical consequence to the eligibility based on the Apfel riskscore15 reflecting the population most at risk for PONV.However, there is no convincing evidence that the responseinmenwould be different with respect to antiemetic response.The difference in response would most likely be due to the differencesin the control event rate in prevention studies.The NNRS scores and the times to PONV or discharge weresimilar between the vestipitant and ondansetron treatmentgroups. In addition, administration of vestipitant andondansetronin these surgical patients was safe and well tolerated witha low number of adverse events.Although several strategies are available for the preventionof PONV, there are fewer effective treatment options after theonset of PONV.16 17 This is primarily because of the difficultyof conducting interventional trials for PONV. Owing to thedifficulty in predicting PONV after failed prophylaxis, thesestudies require screening a large number of patients, ofwhich a small proportion may subsequently experience PONVand become eligible for enrolment into an interventionaltrial.16 17 Furthermore, the pharmacodynamic features of theavailable preventive agents are different and some (such as the study by Kovac and colleagues, there is good reason toassume that ondansetron in the study by Diemunsch and colleagues,18 Candiotti and colleagues,10 and in the current studyhad some effect and could have been better than placebo hadplacebo been tested.4
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