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Turkish Journal of Anaesthesiology and... Oct 2021Post-operative nausea and vomiting is a frequent complication following anaesthesia. We compared the efficacy and safety of intravenous palonosetron and intravenous...
Efficacy of Palonosetron and Dexamethasone for Prevention of Post-operative Nausea and Vomiting in Female Patients Undergoing Laparoscopic Cholecystectomy: A Prospective Randomised Double-Blind Trial.
OBJECTIVE
Post-operative nausea and vomiting is a frequent complication following anaesthesia. We compared the efficacy and safety of intravenous palonosetron and intravenous dexamethasone as prophylactic antiemetic in patients undergoing laparoscopic cholecystectomy.
METHODS
After obtaining institutional ethical committee approval, 100 adult female patients undergoing laparoscopic cholecystectomy were randomised to receive 4mg dexamethasone (group I, n ¼ 50) or 0.075 mg palonosetron (group II, n ¼ 50) intravenously (IV) over 2-5 minutes prior to induction of anaesthesia. Standard anaesthetic technique was followed, and the residual neuromuscular block was antagonised at theend of the procedure. A single anaesthesiologist assessed all the cases for post-operative nausea and vomiting (PONV) for 24 hours. The complete response rate and the overall patient satisfaction were noted. If patient experienced PONV, injection metoclopramide 10 mg was given as rescue antiemetic IV.
RESULTS
A total of six patients had vomiting within 6 hours (four patients in groups I and two patients in group II), whereas none had vomiting after 6 hours (P ¼ .39). Complete response rate was 88 and 90% in both group I and group II. Three patients in both group I and group II required rescue antiemetics. Ninety-two percent patients were completely satisfied in group I, while 96% patients were fully satisfied in group II.
CONCLUSION
Intravenous administration of palonosetron (0.075 mg) is as effective as dexamethasone (4 mg) as prophylactic antiemetic without any untoward side effects for female patients undergoing laparoscopic cholecystectomy.
PubMed: 35110042
DOI: 10.5152/TJAR.2021.191 -
Romanian Journal of Anaesthesia and... Jul 2021For the prevention of PONV, we evaluated the efficacy of palonosetron compared with ondansetron along with dexamethasone in patients undergoing laparoscopic...
Antiemetic Efficacy of Palonosetron Compared with the Combination of Ondansetron and Dexamethasone for Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gynaecological Surgery.
BACKGROUND AND AIMS
For the prevention of PONV, we evaluated the efficacy of palonosetron compared with ondansetron along with dexamethasone in patients undergoing laparoscopic gynaecological surgery.
METHODS
A total of 84 adults, posted for elective laparoscopic surgeries under general anaesthesia were included in the study. The patients were randomly allocated to two groups (n = 42 each). Immediately after induction, patients in the first group (group I) received 4 mg ondansetron with 8 mg dexamethasone, and patients in the second group (group II) received 0.075 mg palonosetron. Any incidences of nausea and/or vomiting, the requirement of rescue antiemetic, and side effects were recorded.
RESULTS
In group I, 66.67% of the patients had an Apfel score of 2, and 33.33% of the patients had a score of 3. In group II, 85.71% of patients had an Apfel score of 2, and 14.29% of the patients had a score of 3. At 1, 4, and 8 hours, the incidence of PONV was comparable in both groups. At 24 hours there was a significant difference in the incidence of PONV in the group treated with ondansetron with dexamethasone combination (4/42) when compared to the palonosetron group (0/42). The overall incidence of PONV was significantly higher in group I (23.81%: ondansetron and dexamethasone combination) than in group II (7.14%: palonosetron). The need for rescue medication in group I was significantly high. Conclusion: Palonosetron was more efficacious compared to the combination of ondansetron and dexamethasone for preventing PONV for laparoscopic gynaecological surgery.
PubMed: 36846536
DOI: 10.2478/rjaic-2021-0003 -
Supportive Care in Cancer : Official... Dec 2023Chemotherapy-induced nausea and vomiting (CINV) are common adverse events in patients undergoing emetogenic chemotherapy. Palonosetron, a second-generation... (Meta-Analysis)
Meta-Analysis
PURPOSE
Chemotherapy-induced nausea and vomiting (CINV) are common adverse events in patients undergoing emetogenic chemotherapy. Palonosetron, a second-generation 5-hydroxytryptamine-3 receptor antagonist (5-HT3 RA), has demonstrated non-inferiority to first-generation 5-HT3 RAs for CINV in pediatric patients. Although palonosetron has a long half-life and prolonged antiemetic action, its efficacy against delayed CINV in pediatric patients is not well understood. Therefore, this meta-analysis of randomized controlled trials (RCTs) aimed to evaluate the efficacy of palonosetron for delayed CINV in pediatric patients.
METHODS
A literature search of MEDLINE/PubMed, Embase, Cochrane Library, and Web of Science databases was performed. A meta-analysis was performed using forest plots, and risk ratios (RRs) and 95% confidence intervals (CIs) were calculated. A funnel plot was constructed to explore publication bias.
RESULTS
The literature search retrieved 842 records, of which 23 full-text articles were assessed, including six RCTs. Meta-analysis of four RCTs that reported on the complete response (CR: defined as no emesis and no rescue medication) rate for delayed CINV revealed that palonosetron was statistically superior to first-generation 5-HT3 RAs (RR = 1.21 [95% CI 1.09-1.35]; p < 0.01). Although the number of studies included was small, no publication bias was observed in the funnel plots. In addition, the CR rate for overall and acute CINV was also significantly higher for palonosetron (RR = 1.25 [95% CI 1.01-1.54]; p = 0.04 and RR = 1.06 [95% CI 1.01-1.12]; p = 0.03, respectively).
CONCLUSION
Palonosetron is effective in the prophylaxis of delayed CINV in pediatric patients.
Topics: Humans; Child; Palonosetron; Isoquinolines; Quinuclidines; Nausea; Antiemetics; Vomiting; Antineoplastic Agents; Serotonin 5-HT3 Receptor Antagonists
PubMed: 38145979
DOI: 10.1007/s00520-023-08283-4 -
Medicine Dec 2023A multimodal therapeutic strategy for preventing postoperative nausea and vomiting (PONV) benefits moderate- and high-risk surgical patients. We compared the efficacy of... (Randomized Controlled Trial)
Randomized Controlled Trial
Comparison of the antiemetic efficacy of a combination of midazolam with ramosetron and midazolam with palonosetron for postoperative nausea and vomiting prophylaxis in laparoscopic cholecystectomy.
BACKGROUND
A multimodal therapeutic strategy for preventing postoperative nausea and vomiting (PONV) benefits moderate- and high-risk surgical patients. We compared the efficacy of a combination of midazolam and ramosetron and a combination of midazolam and palonosetron for PONV prophylaxis in patients scheduled for laparoscopic cholecystectomy.
METHODS
We enrolled 68 patients aged 20 to 65 years undergoing laparoscopic cholecystectomy. Patients were randomly allocated to the midazolam 0.05 mg/kg with ramosetron 0.3 mg (MR) or midazolam 0.05 mg/kg with palonosetron 0.075 mg (MP) groups. The incidence of PONV, severity of nausea, use of rescue antiemetics, and pain severity were evaluated at 2, 24, and 48 hours after surgery.
RESULTS
The incidence (38.2% vs 5.9%) and severity of postoperative nausea were significantly lower in the MP group at 2 hours after surgery (P < .05). There were no significant differences in the incidence of vomiting, use of rescue antiemetics, or pain severity between the 2 groups.
CONCLUSION
The combination of midazolam with palonosetron significantly decreased the incidence and severity of postoperative nausea compared with midazolam combined with ramosetron, especially in the early postoperative phase (0-2 hours) in patients undergoing laparoscopic cholecystectomy.
Topics: Humans; Antiemetics; Palonosetron; Postoperative Nausea and Vomiting; Midazolam; Cholecystectomy, Laparoscopic; Double-Blind Method; Benzimidazoles
PubMed: 38206711
DOI: 10.1097/MD.0000000000036824 -
European Journal of Clinical... Nov 2021Chemotherapy-induced nausea and vomiting (CINV) commonly occurs after chemotherapy, adversely affecting patients' quality of life. Recently, studies have shown... (Meta-Analysis)
Meta-Analysis
PURPOSE
Chemotherapy-induced nausea and vomiting (CINV) commonly occurs after chemotherapy, adversely affecting patients' quality of life. Recently, studies have shown inconsistent antiemetic effects of two common 5-hydroxytryptamine 3 receptor antagonists, namely, palonosetron and granisetron. Therefore, we conducted a meta-analysis to evaluate the effectiveness of palonosetron versus granisetron in preventing CINV.
METHODS
Relevant studies were obtained from PubMed, Embase, and Cochrane databases. The primary outcome was the complete response (CR) rate. Secondary outcomes were headache and constipation events.
RESULTS
In total, 12 randomized controlled trials and five retrospective studies were reviewed. Palonosetron was consistently statistically superior to granisetron in all phases in terms of the CR rate (acute phases: odds ratio [OR] = 1.28, 95% confidence interval [CI] = 1.06-1.54; delayed phases: OR = 1.38, 95% CI = 1.13-1.69; and overall phases: OR = 1.37, 95% CI = 1.17-1.60). Moreover, a non-significant difference was found between the two groups in terms of the headache event, but the occurrence of the constipation event was lower in the granisetron group than in the palonosetron group.
CONCLUSION
Palonosetron showed a higher protective efficacy in all phases of CINV prevention, especially in delayed phases, and no relatively severe adverse effects were observed.
Topics: Antiemetics; Antineoplastic Agents; Granisetron; Humans; Nausea; Palonosetron; Quality of Life; Randomized Controlled Trials as Topic; Serotonin 5-HT3 Receptor Antagonists; Vomiting
PubMed: 33993343
DOI: 10.1007/s00228-021-03157-2 -
Current Radiopharmaceuticals 2024To investigate the mechanism of nausea and vomiting after TACE, and analyze the efficacy and safety of palonosetron hydrochloride in the prevention of nausea and...
PURPOSE
To investigate the mechanism of nausea and vomiting after TACE, and analyze the efficacy and safety of palonosetron hydrochloride in the prevention of nausea and vomiting after TACE.
METHODS
The data of 221 patients who underwent TACE in the Department of Intervention Therapy from August 2018 to August 2020 were collected. The patients were divided into two groups: those who did not use palonosetron hydrochloride before TACE (TACE group, N=116); and those who used palonosetron hydrochloride before TACE (TACE+palonosetron group, N=105). Primary study endpoint: The control rate of nausea and vomiting in the two groups at 0-24 h (acute), 24-120 h (delayed), and 0-120 h. Secondary Study Endpoints: Adverse events of palonosetron hydrochloride.
RESULTS
TACE group vs TACE+palonosetron group: 0-24 h, 74 vs. 44 patients with nausea (63.8% vs. 41.9%); 24-120 h, 50 vs. 16 patients with nausea (43.1% vs. 15.2%); 0-120 h after TACE, 81 vs. 50 patients with nausea (69.8% vs. 47.6%). 0-24 h, 52 vs. 26 patients with vomiting (44.8% vs. 24.8%); 24-120 h, 24 vs. 8 patients with vomiting (20.7% vs. 7.6%); 0-120 h after TACE, 64 vs. 26 patients with vomiting (55.2% vs. 24.8%). The incidence of nausea and vomiting after TACE was significantly lower in the TACE+palonosetron group than in the TACE group (p < 0.05).
CONCLUSION
Palonosetron hydrochloride can significantly reduce the incidence of nausea and vomiting in patients after TACE, with exact effect and high safety.
Topics: Humans; Palonosetron; Male; Female; Retrospective Studies; Aged; Middle Aged; Nausea; Vomiting; Antiemetics; Chemoembolization, Therapeutic; Treatment Outcome; Aged, 80 and over
PubMed: 38037910
DOI: 10.2174/0118744710261186231026062257 -
European Journal of Pharmaceutical... May 2021Palonosetron hydrochloride is a specific 5-HT3 receptor antagonist, used to prevent chemotherapy-induced nausea and vomiting (CINV), and is a known chemical entity... (Randomized Controlled Trial)
Randomized Controlled Trial
PURPOSE
Palonosetron hydrochloride is a specific 5-HT3 receptor antagonist, used to prevent chemotherapy-induced nausea and vomiting (CINV), and is a known chemical entity currently registered in the oral and IV forms in several countries worldwide.
METHODS
Single-center, single-dose, 3-treatment, open-label, randomized, 3-period, phase-I cross-over study, conducted in 18 individuals (16 males and 2 females). The primary objective was to assess the pharmacokinetic profile of Palonosetron 0.25, 0.5 and 0.75mg, after a single, oral administration in Chinese male and female healthy volunteers.
RESULTS
After administration of a single oral dose of 0.25mg, 0.5mg, or 0.75mg palonosetron in Chinese male and female healthy subjects, plasma palonosetron concentrations reached maximum values (C) of 673 ± 151 pg/mL, 1330 ± 258 pg/mL, and 1990 ± 490 pg/mL, respectively, at 3-5 h (t). The plasma elimination half-life for 0.25, 0.5 and 0.75 mg of palonosetron was 41.8±9.72 hours, 44.6±8.59 hours and 42.3±8.51 hours, respectively. Single oral doses of 0.25mg, 0.5mg, or 0.75mg palonosetron were safe and well tolerated among all the 18 subjects involved.
CONCLUSIONS
The PK of palonosetron was found to be linear in the dose range of 0.25 to 0.75 mg. Oral palonosetron in doses up to 0.75 mg was well tolerated in healthy Chinese subjects. The PK and safety data obtained from this study were similar to previous phase I studies with IV palonosetron.
Topics: Antiemetics; China; Cross-Over Studies; Female; Healthy Volunteers; Humans; Isoquinolines; Male; Palonosetron; Quinuclidines; Vomiting
PubMed: 33581259
DOI: 10.1016/j.ejps.2021.105752 -
Hong Kong Medical Journal = Xianggang... Feb 2023This post-hoc analysis retrospectively assessed data from two recent studies of antiemetic regimens for chemotherapy-induced nausea and vomiting (CINV). The primary...
INTRODUCTION
This post-hoc analysis retrospectively assessed data from two recent studies of antiemetic regimens for chemotherapy-induced nausea and vomiting (CINV). The primary objective was to compare olanzapine-based versus netupitant/palonosetron (NEPA)-based regimens in terms of controlling CINV during cycle 1 of doxorubicin/cyclophosphamide (AC) chemotherapy; secondary objectives were to assess quality of life (QOL) and emesis outcomes over four cycles of AC.
METHODS
This study included 120 Chinese patients with early-stage breast cancer who were receiving AC; 60 patients received the olanzapine-based antiemetic regimen, whereas 60 patients received the NEPA-based antiemetic regimen. The olanzapine-based regimen comprised aprepitant, ondansetron, dexamethasone, and olanzapine; the NEPA-based regimen comprised NEPA and dexamethasone. Patient outcomes were compared in terms of emesis control and QOL.
RESULTS
During cycle 1 of AC, the olanzapine group exhibited a higher rate of 'no use of rescue therapy' in the acute phase (olanzapine vs NEPA: 96.7% vs 85.0%, P=0.0225). No parameters differed between groups in the delayed phase. The olanzapine group had significantly higher rates of 'no use of rescue therapy' (91.7% vs 76.7%, P=0.0244) and 'no significant nausea' (91.7% vs 78.3%, P=0.0408) in the overall phase. There were no differences in QOL between groups. Multiple cycle assessment revealed that the NEPA group had higher rates of total control in the acute phase (cycles 2 and 4) and the overall phase (cycles 3 and 4).
CONCLUSION
These results do not conclusively support the superiority of either regimen for patients with breast cancer who are receiving AC.
Topics: Humans; Female; Antiemetics; Palonosetron; Olanzapine; Quality of Life; Retrospective Studies; Dexamethasone; Vomiting; Nausea; Breast Neoplasms; Antineoplastic Agents
PubMed: 36810240
DOI: 10.12809/hkmj209182 -
Journal of Pharmaceutical Health Care... Jun 2021Recently, aprepitant has been recommended in carboplatin-based regimens, but there are limited reports on the efficacy of administering aprepitant, palonosetron, and...
BACKGROUND
Recently, aprepitant has been recommended in carboplatin-based regimens, but there are limited reports on the efficacy of administering aprepitant, palonosetron, and dexamethasone (DEX) in carboplatin-containing regimens. Moreover, because aprepitant is an expensive drug, confirming its effectiveness is very important from the medical cost perspective. In this study, we examined the efficacy of prophylactically administered aprepitant, palonosetron and DEX, in paclitaxel and carboplatin (TC) combination chemotherapy.
METHODS
Patients with gynecologic cancer who were treated with paclitaxel (175 mg/m) and carboplatin (area under the curve, AUC = 5-6) combination chemotherapy were retrospectively evaluated. The complete response (CR) rate, severity of nausea, and incidence of anorexia in the first course were compared between patients who did not receive aprepitant (control group) and those who received (aprepitant group).
RESULTS
The 106 patients were divided into two groups, consisting of 52 and 54 the control and aprepitant groups, respectively, and the patient background showed no significant difference between both groups. The CR rate of the overall phase between the control and aprepitant groups was 73.1 vs. 74.1%, that in the acute phase was 98.1 vs. 100%, and in the delayed phase was 75.0 vs. 74.1%, respectively, without any significant difference. The severity of nausea and incidence of anorexia were also not significantly different between both groups.
CONCLUSIONS
The results of the study suggest that adding aprepitant to palonosetron and DEX does not prevent carboplatin-induced nausea and vomiting in gynecologic cancer patients. Therefore, adding aprepitant to palonosetron does not decrease carboplatin-induced nausea and vomiting in patients with gynecologic cancer.
PubMed: 34059157
DOI: 10.1186/s40780-021-00204-z -
Future Oncology (London, England) Aug 2021In the absence of comparative studies, guidelines consider neurokinin 1 receptor antagonists (RAs) as interchangeable. We evaluated the pooled efficacy from... (Comparative Study)
Comparative Study
In the absence of comparative studies, guidelines consider neurokinin 1 receptor antagonists (RAs) as interchangeable. We evaluated the pooled efficacy from three cisplatin registration trials, each with arms containing netupitant/palonosetron (NEPA), a fixed neurokinin 1 RA (netupitant)/serotonin Type 3 (5-HT3) RA (palonosetron) combination, and an aprepitant (APR) regimen. Efficacy data were pooled for rates of complete response (CR: no emesis/no rescue medication), complete protection (CR + no significant nausea), total control (CR + no nausea) and no significant nausea during acute (0-24 h), delayed (>24-120 h) and overall (0-120 h) phases post chemotherapy. Among 621 NEPA and 576 APR patients, response rates were similar for the acute phase, and generally favored NEPA during delayed and overall phases. CR rates for NEPA versus APR were 88.4 versus 89.2%, 81.8 versus 76.9% (p < 0.05) and 78.4 versus 75.0% during the acute, delayed and overall phases, respectively. Oral NEPA administered on day 1 was more effective than a 3-day APR regimen in preventing delayed nausea and vomiting associated with cisplatin.
Topics: Administration, Oral; Adult; Antiemetics; Antineoplastic Agents; Aprepitant; Cisplatin; Clinical Trials, Phase II as Topic; Clinical Trials, Phase III as Topic; Drug Administration Schedule; Drug Combinations; Female; Humans; Isoquinolines; Male; Middle Aged; Multicenter Studies as Topic; Nausea; Neoplasms; Pyridines; Quinuclidines; Randomized Controlled Trials as Topic; Vomiting
PubMed: 33878896
DOI: 10.2217/fon-2021-0023