Aprepitant plus palonosetron for the prevention of postoperative nausea and vomiting after breast cancer surgery: a double blind, randomized trial

Abstract

To evaluate the addition of a fourth antiemetic intervention in patients at high risk for postoperative nausea and vomiting (PONV). METHODS: High-risk patients (Apfel score 3 or 4) scheduled for unilateral mastectomy were randomly allocated in one of two groups, oral aprepitant (oral aprepitant 80 mg, intravenous dexamethasone 8 mg, and palonosetron 0.075 mg) and oral placebo (oral placebo, intravenous dexamethasone 4 mg, and palonosetron 0.075 mg). Patients and caregivers were blinded to the group assignments. The primary efficacy endpoints included the incidence of nausea and vomiting, and the secondary endpoints included use of rescue antiemetics during a 48-hour postoperative period. ClinicalTrials.gov: NCT02431286. RESULTS: One hundred patients were enrolled in this study and 91 were analyzed, 48 in group A and 43 in group P. No patient presented with nausea or vomiting in the first 2 hours after surgery. From the 2 nd to the 6 th hour, the incidence of PONV was 8.33% in group A and 9.30% in group P. In the first 24 hours, the incidence of PONV was 27.08% in the group A and 20.93% in group P. From the 24 th to the 48 th hour, the incidence of PONV was 8.33% in group A and 13.95% in group P. There were no statistically significant differences in PONV between groups. CONCLUSION: The addition of aprepitant as a third antiemetic resulted in no significant reduction in the incidence of PONV in this population. However, the incidence of PONV was reduced in relation to the general population.

The efficacy of aprepitant for the prevention of postoperative nausea and vomiting: A meta-analysis

“…All operations were performed under general anesthesia (including 5 studies that used fentanyl for postoperative patient-controlled analgesia). The following different doses of aprepitant were used in 17 trials: 40 mg, [22,25,[27][28][29] 80 mg, [9,[12][13][14][15][18][19][20][21]23,26] and 125 mg. [20,21,23,[27][28][29] In the intervention group, a precipitant was primarily or adjunctively used as an emetic agent. In the control group, ondansetron, dexamethasone, palonosetron, ramosetron, or placebo was administered alone or in combination.…”

“…Six studies reported the incidence of nausea and vomiting. [9,[12][13][14]23,24] Findings showed that administration of…”

“…Use of a rescue antiemetic. An assessment of 12 studies that assessed the use of a rescue antiemetic [9,[12][13][14]18,20,21,[24][25][26][27][28][29] showed no significant inter-group differences (OR: 0.86; 95% CI: 0.68,1. 09; P = .21) (Figure S1E, Supplemental Digital Content, http://links.lww.com/MD/J322).…”

“…Although an increasing number of studies on the use of aprepitant in clinical practice have been reported in recent years, its effectiveness in preventing PONV remains unclear. [4,[12][13][14][15] We conducted a meta-analysis of randomized controlled trials (RCTs) to understand better how aprepitant use affects current PONV management strategies with a view to improving patient postoperative comfort.…”

Effect of Palonosetron on Physical Symptoms of Surgical Patients: A Systematic Review and Meta-Analysis

“…In recent research, it has been shown that antiemetic 5-HT3 antagonists may be beneficial in the prevention of postoperative nausea and vomiting (PONV) [ 6 ]. As a result, these drugs are now routinely used to prevent PONV in a variety of conditions [ 7 ]. Among the most often prescribed drugs in today's medical world are the 5-HT3 receptor antagonist pharmaceuticals ondansetron, ramosetron, tropisetron, and granisetron.…”