Palonosetron versus ondansetron as rescue medication for postoperative nausea and vomiting: a randomized, multicenter, open-label study

BMC Clinical Pharmacology

Tong J Gan¹  David Cox³  Syed Raza Ahmed²  Keith A Candiotti⁴ 

[1] Duke University Medical Center, 2100 Erwin Road, 27710 Durham, NC, USA;Becton, Dickinson and Company, 1 Becton Drive, 07417 Franklin Lakes, NJ, USA;Eisai Inc., 100 Tice Boulevard, 07677 Woodcliff Lake, NJ, USA;University of Miami–Jackson Memorial Hospital, 1611 NW 12th Avenue, Room 300, 33136 Miami, FL, USA

关键词: Ondansetron;    Palonosetron;    Antiemetics;    Postoperative nausea and vomiting;   

Others  :  1084846
DOI  :  10.1186/2050-6511-15-45

 received in 2013-12-18, accepted in 2014-08-06,  发布年份 2014

【 摘 要 】

Background

This study compared palonosetron and ondansetron as rescue medications for postoperative nausea and vomiting (PONV) in patients who received prophylactic ondansetron. Although guidelines recommend use of an agent from a different class when prophylaxis has failed, palonosetron has unique properties relative to other serotonin 5-HT₃ receptor antagonists. Prior trials assessing its use for rescue have had conflicting results. Although palonosetron has compared favorably with ondansetron for PONV prevention, the drugs have not been compared in the rescue setting of failure of 5-HT₃ receptor antagonist prophylaxis.

Methods

This was a randomized, open-label, multicenter trial comparing the efficacy and safety of intravenous palonosetron 0.075 mg and intravenous ondansetron 4 mg in patients experiencing PONV following laparoscopic abdominal or gynecological surgery despite prophylactic ondansetron.

Results

Of 239 patients screened, 220 were enrolled and 98 were treated for PONV: 48 and 50 in the palonosetron and ondansetron arms, respectively. Complete control during 72 hours after study drug administration was achieved in 25.0% of palonosetron recipients and 18.0% of ondansetron recipients (95% confidence interval [CI], -9.2, 23.3; p = 0.40). Corresponding incidences of vomiting were 29.2% for palonosetron and 48.0% for ondansetron (95% CI, -0.06, 37.7; p = 0.057), and 62.5% and 56.0% required additional rescue treatment, respectively (95% CI, -25.9, 12.9; p = 0.52). Other than a similar incidence of procedural pain in the 2 groups, the most common treatment-emergent adverse events, which were generally mild, were headache (14.6% vs 12.0%), constipation (8.3% vs 10.0%), and dizziness (6.3% vs 8.0%), for the palonosetron and ondansetron groups, respectively.

Conclusions

Palonosetron and ondansetron did not show differences in the primary efficacy endpoint of CC during the 72 hours after study drug administration. There was a trend toward less emesis in the 0–72 h time period favoring palonosetron. While larger studies are needed to fully assess any clinical benefits of palonosetron to rescue patients who have failed ondansetron prophylaxis for PONV, the benefit, if any, would be limited based on this study.

Trial registration

ClinicalTrials.gov, NCT00967499 (Registered August 27, 2009)

【 授权许可】

   
2014 Candiotti et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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