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British Journal of Anaesthesia Aug 2023Approximately 25% of ambulatory surgery patients experience post-discharge nausea and vomiting (PDNV). We aimed to investigate whether palonosetron, a long-acting... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Approximately 25% of ambulatory surgery patients experience post-discharge nausea and vomiting (PDNV). We aimed to investigate whether palonosetron, a long-acting anti-emetic, decreases the incidence of PDNV in high-risk patients.
METHODS
In this prospective, randomised, double-blind, placebo-controlled trial, 170 male and female patients undergoing ambulatory surgery under general anaesthesia, with a high predicted risk for PDNV, were randomised to receive either palonosetron 75 μg i.v. (n=84) or normal saline (n=86) before discharge. During the first 3 postoperative days (PODs), we measured outcomes using a patient questionnaire. The primary outcome was the incidence of a complete response (no nausea, vomiting, or use of rescue medication) until POD 2. Secondary outcomes included the incidence of PDNV each day until POD 3.
RESULTS
The incidence of a complete response until POD 2 was 48% (n=32) in the palonosetron group and 36% (n=25) in the placebo group (odds ratio 1.69 [95% confidence interval: 0.85-3.37]; P=0.131). No significant difference in the incidence of PDNV was observed between the two groups on the day of surgery (47% vs 56%; P=0.31). Significant differences in the incidence of PDNV were found on POD 1 (18% vs 34%; P=0.033) and POD 2 (9% vs 27%; P=0.007). No differences were observed on POD 3 (15% vs 13%; P=0.700).
CONCLUSIONS
Compared with placebo, palonosetron did not reduce the overall incidence of post-discharge nausea and vomiting up to postoperative day 2. The lower incidence of post-discharge nausea and vomiting on poatoperative days 1 and 2 in the palonosetron group requires further investigation.
CLINICAL TRIAL REGISTRATION
EudraCT 2015-003956-32.
Topics: Humans; Male; Female; Palonosetron; Postoperative Nausea and Vomiting; Ambulatory Surgical Procedures; Prospective Studies; Patient Discharge; Aftercare; Antiemetics; Double-Blind Method
PubMed: 37246062
DOI: 10.1016/j.bja.2023.04.034 -
Current Therapeutic Research, Clinical... 2022Spinal surgery is associated with severe pain within the first few days after surgery. Opioids are commonly used to control postoperative pain, but these can lead to... (Review)
Review
BACKGROUND
Spinal surgery is associated with severe pain within the first few days after surgery. Opioids are commonly used to control postoperative pain, but these can lead to postoperative nausea and vomiting (PONV). Therefore, use of more effective and better-tolerated agents would be beneficial for these patients. Serotonin receptor antagonists, such as ramosetron, have been used to reduce PONV in patients receiving anesthesia.
OBJECTIVE
We conducted a meta-analysis of published randomized controlled trials (RCTs) to compare the efficacy and tolerance of ramosetron to prevent PONV after spinal surgery.
METHODS
Medline, Embase, Cochrane Library, and Science Citation Index databases were systematically searched for relevant RCT articles published between January 1979 and November 2020. Full text articles restricted to English language that described RCTs comparing the use of ramosetron with other serotonin antagonists to treat PONV following spinal surgery in adult patients were considered for meta-analysis. Two reviewers independently performed study selection, quality assessment, and data extraction of all articles. Differences were resolved by a third reviewer.
RESULTS
The search identified 88 potentially relevant articles, of which only 3 met our selection criteria. Study drugs were administered at the end of spinal surgery in all 3 included articles. The meta-analysis revealed that ramosetron (0.3 mg) reduced the pain score (mean difference = -0.66; 95% CI -1.02 to -0.30), lowered the risk of PONV (risk ratio = 0.86; 95% CI, 0.76-0.97), and postoperative vomiting (risk ratio = 0.32; 95% CI, 0.17-0.60), and limited the use of rescue antiemetics (risk ratio = 0.66; 95% CI, 0.45-0.96) after spinal surgery. However, there were no significant differences in the incidence of postoperative nausea, the use of rescue pain medications, the number of rescue analgesics required, and the risk of discontinuation of patient-controlled analgesia between ramosetron and palonosetron (0.075 mg) or ondansetron (4 mg). There were no statistically significant differences in the risk of adverse events among the 3 medications.
CONCLUSIONS
This meta-analysis of 3 RCTs showed that ramosetron reduced the risk of PONV and POV, limited the use of rescue antiemetics, reduced the postoperative pain score, and did not increase the risk of discontinuing patient-controlled analgesia compared with palonosetron or ondansetron after spinal surgery in 3 RCTs. Therefore, this meta-analysis indicates that ramosetron is an effective and well tolerated antiemetic that can be used to prevent PONV following spinal surgery in adult patients. PROSPERO identifier: CRD42020223596 (. 2022; 83:XXX-XXX)© 2022 Elsevier HS Journals, Inc.
PubMed: 35464291
DOI: 10.1016/j.curtheres.2022.100666 -
Journal of Personalized Medicine Dec 2022This updated systematic review and meta-analysis with trial sequential analysis aimed to compare the efficacy of the perioperative administration of palonosetron with... (Review)
Review
Comparison of the Effectiveness of Palonosetron and Ramosetron in Preventing Postoperative Nausea and Vomiting: Updated Systematic Review and Meta-Analysis with Trial Sequential Analysis.
This updated systematic review and meta-analysis with trial sequential analysis aimed to compare the efficacy of the perioperative administration of palonosetron with that of ramosetron in preventing postoperative nausea and vomiting (PONV). A total of 17 randomized controlled trials comparing the efficacy of the perioperative administration of palonosetron to that of ramosetron for preventing PONV were included. The primary outcomes were the incidences of postoperative nausea (PON), postoperative vomiting (POV), and PONV, which were measured in early, late, and overall phases. Subgroup analysis was performed on the basis of the administration time of the 5-HT3 receptor antagonist and divided into two phases: early phase and the end of surgery. A total of 17 studies with 1823 patients were included in the final analysis. The incidence of retching (relative risk [RR] = 0.525; 95% confidence interval [CI] = 0.390 to 0.707) and late POV (RR = 0.604; 95% CI = 0.404 to 0.903) was significantly lower in the palonosetron group than in the ramosetron group. No significant differences were demonstrated in the incidence of PON, PONV, complete response, use of antiemetics, and adverse effects. Subgroup analysis showed that palonosetron was superior to ramosetron in terms of early PON, late PON, overall POV, and use of rescue antiemetics when they were administered early; in terms of retching, regardless of the timing of administration. Ramosetron was superior to palonosetron in terms of early PON when they were administered late. The prophylactic administration of palonosetron was more effective than that of ramosetron in preventing the development of retching and late POV. In this meta-analysis, no significant differences in PONV prevention between the two drugs were demonstrated. Further studies are required to validate the outcomes of our study.
PubMed: 36675743
DOI: 10.3390/jpm13010082 -
Journal of Pharmaceutical Health Care... Aug 2022Cisplatin (CDDP)-induced nephrotoxicity is the most important complication of CDDP treatment. 5-Hydroxytryptamine type 3 receptor antagonists (5-HTRAs) are widely used...
BACKGROUND
Cisplatin (CDDP)-induced nephrotoxicity is the most important complication of CDDP treatment. 5-Hydroxytryptamine type 3 receptor antagonists (5-HTRAs) are widely used to prevent chemotherapy-induced nausea and vomiting (CINV). However, in patients with the triple antiemetic (neurokinin-1 receptor antagonist, 5-HTRA, and dexamethasone) therapy, the advantage of palonosetron in comparison with other 5-HTRAs on CDDP-induced nephrotoxicity and CINV remains unclear. In the present study, we investigated the effect of palonosetron on CDDP-induced nephrotoxicity and CINV in patients with the triple antiemetic therapy by a retrospective cohort study and a pharmacovigilance analysis.
METHODS
We retrospectively analyzed the effect of 5-HTRAs on the development of nephrotoxicity and CINV in 110 patients who received CDDP, fluorouracil, and triple antiemetic therapy for the treatment of esophageal cancer. Moreover, the effect of 5-HTRAs on CDDP-induced nephrotoxicity was validated in patients with the triple antiemetic therapy using the Japanese Adverse Drug Event Report (JADER) database.
RESULTS
In a retrospective study, the incidence of nephrotoxicity (≥ grade 1) in patients receiving palonosetron (18%) was significantly lower than that in patients receiving ramosetron (another 5-HTRA) (36%, p = 0.044). Moreover, severe nephrotoxicity ≥ grade 3 was observed in one patient treated with ramosetron, whereas hematological toxicity was comparable between the two groups (p = 0.553). Furthermore, the incidence rate of CINV within 120 h following CDDP administration in patients treated with palonosetron (18%) was significantly lower than that in patients receiving ramosetron (39%, p = 0.026). JADER database analyses revealed that the reporting odds ratio of palonosetron for CDDP-induced acute kidney injury was 0.282 (95% confidence interval: 0.169-0.472).
CONCLUSIONS
The findings of the present study suggested a greater potential of palonosetron against CDDP-induced nephrotoxicity and CINV than other 5-HTRAs in patients with the triple antiemetic therapy.
PubMed: 35909131
DOI: 10.1186/s40780-022-00252-z -
Anesthesia, Essays and Researches 2022Postoperative nausea and vomiting (PONV) are one of the common distressing conditions after anesthesia. The PONV are related to several potential risk factors are...
Comparison of Palonosetron Versus Palonosetron and Dexamethasone for Prevention of Postoperative Nausea and Vomiting After Middle Ear Surgeries: A Randomized Controlled Study.
BACKGROUND
Postoperative nausea and vomiting (PONV) are one of the common distressing conditions after anesthesia. The PONV are related to several potential risk factors are patient related, anesthesia related, and surgery related. In surgery-related risk, middle ear surgery is associated with a high incidence of PONV.
AIMS
This study aimed to compare the efficiency of palonosetron versus palonosetron with dexamethasone in the prevention of PONV in middle ear surgeries.
SETTINGS AND DESIGN
This was a prospective, randomized, double-blind study.
STATISTICAL ANALYSIS
The data were presented as descriptive statistics for continuous variables and percentages for categorical variables and were subjected to Z-test/Chi-square test/Fisher's exact test. The value of < 0.05 was considered statistically significant.
RESULTS
Demographic parts in comparison to age, duration of surgery, and duration of anesthesia were similar in both the groups. Our study showed that the incidence of PONV during 0-6 h was 38% ( = 19) in Group A and 12% ( = 6) in Group B and the incidence during 6-12 h postoperatively was 14% ( = 7) in Group A and 8% ( = 4) in Group B. During 12-24 h, the incidence was 8% ( = 4) and 6% ( = 3) in Group A and B, respectively. Hence, the difference of total early PONV in Group A was 60% ( = 30) and in Group B, it was 26% ( = 13) which was statistically significant ( < 0.03).
CONCLUSIONS
The above result proves that palonosetron and dexamethasone group is superior in the prevention of PONV in middle ear surgery.
PubMed: 36249139
DOI: 10.4103/aer.aer_131_21 -
Core Evidence 2015The second-generation 5-hydroxytryptamine-3 (5-HT3) receptor antagonist palonosetron is effective in the prevention of chemotherapy-induced nausea and vomiting (CINV)... (Review)
Review
INTRODUCTION
The second-generation 5-hydroxytryptamine-3 (5-HT3) receptor antagonist palonosetron is effective in the prevention of chemotherapy-induced nausea and vomiting (CINV) associated with highly and moderately emetogenic chemotherapy (HEC and MEC, respectively). In addition, palonosetron has been the first and, at present, the only 5-HT3 receptor antagonist to have a specific indication for the prevention of delayed CINV associated with MEC. The unique pharmacology of this antagonist is thought to partly explain its improved efficacy against delayed symptoms.
AIMS
To review the evidence underlying the use of palonosetron in preventing CINV.
EVIDENCE REVIEW
A recent meta-analysis consistently showed that palonosetron significantly increases the control of both emesis and nausea during the acute and delayed phases after single-day HEC or MEC. Consistent with these findings from trials that did not include an neurokinin-1 (NK-1) receptor antagonist, randomized controlled trials recently showed that a triple combination with palonosetron achieves significantly better control of delayed CINV, particularly delayed nausea, in patients undergoing HEC or the high-risk combination of an anthracycline and cyclophosphamide (AC). Evidence from randomized studies also supports palonosetron as a valuable option to reduce the total corticosteroid dose administered in patients undergoing multiple cycles of MEC or AC chemotherapy. Additional benefits of palonosetron include the lack of a warning on cardiac safety and no known clinically significant drug-drug interactions. Place in therapy and conclusion: Evidence currently available indicates that palonosetron significantly adds to the clinician's ability to effectively control CINV in patients undergoing HEC or MEC. It is recommended in the international guidelines for the prevention of CINV caused by MEC. The high safety profile and the opportunity to reduce the total corticosteroid dose with no loss in efficacy against delayed CINV should also contribute to a wider use of palonosetron in clinical practice.
PubMed: 26345982
DOI: 10.2147/CE.S65555 -
The Oncologist 2011We performed a systematic review and meta-analysis to compare treatment effectiveness and adverse effects in cancer patients receiving chemotherapy with palonosetron to... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
We performed a systematic review and meta-analysis to compare treatment effectiveness and adverse effects in cancer patients receiving chemotherapy with palonosetron to prevent chemotherapy-induced nausea and vomiting (CINV).
METHODS
We identified randomized controlled clinical trials (RCT) comparing palonosetron with first-generation 5-HT3RA in the prevention of CINV in cancer patients. Meta-analyses were performed on homogeneous studies. Fixed or random-effects models were used to combine data.
RESULTS
Eight eligible trials were identified, reporting outcomes on 3,592 patients. Meta-analyses showed statistically significant differences in favor of palonosetron compared with first-generation 5-HT3RA in prevention of acute CINV (p = .0003), delayed CINV (p < .00001), and overall phase of CINV (p < .00001). Subgroup analyses showed statistically significant differences in favor of both 0.25 mg and 0.75 mg of palonosetron in prevention of all phases of CINV. There were no statistically significant differences between 0.25 and 0.75 mg of palonosetron. Compared with the first-generation 5-HT3RA, 0.75 mg of palonosetron showed a statistically significant difference in the occurrence of constipation (p = .04).
INTERPRETATION
The use of palonosetron should be considered an integral part of adjuvant therapy for prevention of the acute, delayed, and overall phases of CINV. The 0.25 mg intravenous palonosetron dose is as effective as the 0.75 mg intravenous palonosetron dose. However, 0.75 mg intravenous palonosetron causes constipation more frequently than the first-generation 5-HT3RA.
Topics: Adult; Antiemetics; Antineoplastic Agents; Constipation; Dexamethasone; Headache; Humans; Infusions, Intravenous; Isoquinolines; Nausea; Neoplasms; Palonosetron; Quinuclidines; Serotonin 5-HT3 Receptor Antagonists; Treatment Outcome; Vomiting
PubMed: 21282670
DOI: 10.1634/theoncologist.2010-0198 -
Biological & Pharmaceutical Bulletin 2021Patients who undergo multiple-day chemotherapy sessions experience hard-to-treat nausea and vomiting. Currently, there is no effective standard treatment for this...
Patients who undergo multiple-day chemotherapy sessions experience hard-to-treat nausea and vomiting. Currently, there is no effective standard treatment for this condition. This study compared the preventive effect of first-generation 5-hydroxytryptamine 3 receptor antagonists (5-HT RAs) and second-generation 5-HT RAs palonosetron in multiple-day chemotherapy-induced nausea and vomiting. The design of this study was a retrospective case-control study of patients who received a five-day cisplatin-based chemotherapy and were treated with aprepitant, dexamethasone, granisetron, and ramosetron or palonosetron. The patients were divided into two groups: patients given granisetron and ramosetron (the first-generation group), and those given palonosetron (palonosetron group). The percentage of patients with a complete response or total control was assessed. They were divided into three phases: 0-216 h (overall phase), 0-120 h (remedial phase), and 120-216 h (after phase). The remedial phase was further divided into 0-24 h (early phase) and 24-120 h (later phase). Moreover, the nutritional status of each patient was assessed by noting the patients' total calorie-intake per day and total parenteral nutrition. First-generation 5-HT RAs and palonosetron were used for treatment in 18 and 28 patients, respectively. The complete response rate and caloric oral intake of the later phase were higher in the palonosetron group than in the first-generation group. We conclude that palonosetron treatment was more effective than first-generation 5-HT RAs in controlling multiple-day chemotherapy-induced nausea and vomiting.
Topics: Adult; Antiemetics; Antineoplastic Agents; Benzimidazoles; Bleomycin; Drug Therapy, Combination; Etoposide; Female; Granisetron; Humans; Male; Middle Aged; Nausea; Neoplasms, Germ Cell and Embryonal; Ovarian Neoplasms; Palonosetron; Platinum Compounds; Retrospective Studies; Serotonin 5-HT3 Receptor Antagonists; Testicular Neoplasms; Vomiting
PubMed: 33790099
DOI: 10.1248/bpb.b20-00609 -
British Journal of Anaesthesia Mar 2012
Topics: Antiemetics; Female; Humans; Isoquinolines; Ondansetron; Palonosetron; Postoperative Nausea and Vomiting; Quinuclidines; Thyroidectomy
PubMed: 22337957
DOI: 10.1093/bja/aer516 -
Therapeutics and Clinical Risk... 2015Nausea and vomiting are major adverse effects of chemotherapy and can greatly impact patients' quality of life. Although chemotherapy-induced nausea and vomiting (CINV)... (Review)
Review
PURPOSE
Nausea and vomiting are major adverse effects of chemotherapy and can greatly impact patients' quality of life. Although chemotherapy-induced nausea and vomiting (CINV) prevalence is high, treatment remains difficult. Palonosetron is a 5-hydroxytryptamine receptor antagonist (5-HT3RA) approved for treatment of CINV. The purpose of this review is to discuss existing and emerging therapeutic options, and examine studies focusing on palonosetron with regards to efficacy, pharmacology, tolerability, safety, and patient-derived outcomes.
METHODS
A literature search was conducted using Ovid MEDLINE and EMBASE to identify relevant studies using palonosetron alone or in combination with other antiemetics. Studies were extracted if they included complete response (CR), complete control (CC), no nausea, no vomiting, and no rescue medications as an endpoint. Studies were also included if safety endpoints were examined.
RESULTS
Palonosetron alone has been shown to improve CR and CC rates for patients receiving low, moderate, or high emetogenic chemotherapy. Rates were further improved with the addition of dexamethasone, a corticosteroid. Furthermore, the addition of neurokinin-1 receptor antagonists, such as netupitant markedly improved efficacy profiles compared to palonosetron alone. Aprepitant is an antiemetic that has exhibited positive results in combination with palonosetron. Recently, a new drug consisting of netupitant and palonosetron (NEPA) has demonstrated significantly more efficacious prevention of CINV. Regardless of the combination, palonosetron has been well tolerated. The most common adverse events were constipation, headache, fatigue, and dizziness, with the majority of patients describing them as only mild or moderate.
CONCLUSION
Palonosetron, alone or with other antiemetics, has improved CINV treatment due to its ability to significantly reduce delayed phases of CINV, compared to similar 5-HT3RAs. Palonosetron is both more effective than first generation 5-HT3RAs and safer, as it results in a smaller prolongation of the QTc interval, compared to other 5-HT3RAs.
PubMed: 25999723
DOI: 10.2147/TCRM.S68130