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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 -
Infection Control and Hospital... May 2024In an Indian oncology setting, between August and December 2021, 56 patients, developed bacteremia. An investigation revealed a contaminated batch of the antiemetic...
In an Indian oncology setting, between August and December 2021, 56 patients, developed bacteremia. An investigation revealed a contaminated batch of the antiemetic drug palonosetron. The outbreak was terminated by withdrawing the culprit batch and the findings were reported promptly to regulatory authorities.
Topics: Humans; Burkholderia cenocepacia; Burkholderia Infections; Diving; Disease Outbreaks; Bacteremia
PubMed: 38173359
DOI: 10.1017/ice.2023.241 -
Cureus Nov 2023Background Corticosteroids, specifically dexamethasone (DEX), have been extensively utilized for the prevention of chemotherapy-induced nausea and vomiting (CINV)....
Retrospective Evaluation of a Dexamethasone Sparing Antiemetic Regimen: An Antiemetic Prophylaxis Study on NEPA (Netupitant Plus Palonosetron) for Preventing Chemotherapy-Induced Nausea and Vomiting (CINV) in Cancer Patients.
Background Corticosteroids, specifically dexamethasone (DEX), have been extensively utilized for the prevention of chemotherapy-induced nausea and vomiting (CINV). However, their usage is associated with a range of adverse events. In contrast, the combination of Netupitant Plus Palonosetron (NEPA) with a single dose of DEX provides comparable efficacy in preventing CINV over a five-day period following chemotherapy administration. This regimen offers the advantage of reducing the need for additional doses of DEX, particularly in the high-risk setting of HEC (Highly emetic chemotherapy). Objective To evaluate dexamethasone sparing anti-emetic regimen (single dose dexamethasone with NEPA) for prophylaxis of CINV in patients receiving HEC. Methodology This is a retrospective, observational, real-world, single-center study including data of 69 patients who received high-dose emetogenic chemotherapy and were administered DEX (8 or 12 mg) on day 1, with no dose of DEX on days 2, 3, and 4, combined with an oral combination of tablet netupitant 300 mg and palonosetron 0.5 mg. NEPA was taken orally an hour prior to the start of the HEC cycle. The primary efficacy endpoint was complete response (CR) which is defined as no nausea, emesis, or no rescue medication during the Acute (< 24 hours) and Delayed Phase (25-120 hours) of chemotherapy. Results The overall CR achieved in the acute and delayed phase for vomiting is 100% at all four follow-ups. The CR achieved in the acute phase is 95.7% whereas 98.6% of patients showed CR in the delayed phase respectively. No patient required any rescue medication. No acute and delayed phase of vomiting was reported. Conclusion A simplified regimen of NEPA plus single-dose DEX offers effective CINV prevention throughout five days post-chemotherapy with the advantage of sparing patients additional doses of DEX in the high-emetic-risk setting chemotherapy.
PubMed: 38161895
DOI: 10.7759/cureus.49763 -
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 -
Frontiers in Oncology 2023The use of 5-hydroxytryptamine-3 receptor antagonists (5HTRA) has long been considered the standard regimen for preventing chemotherapy-induced nausea and vomiting...
Comparison of netupitant/palonosetron with 5-hydroxytryptamine-3 receptor antagonist in preventing of chemotherapy-induced nausea and vomiting in patients undergoing hematopoietic stem cell transplantation.
BACKGROUND
The use of 5-hydroxytryptamine-3 receptor antagonists (5HTRA) has long been considered the standard regimen for preventing chemotherapy-induced nausea and vomiting (CINV) prior to hematopoietic stem cell transplantation (HSCT). However, their therapeutic outcomes have been unsatisfactory. NEPA, an oral formulation combining the neurokinin-1 receptor antagonist netupitant and the 5HTRA palonosetron, has received regulatory approval for the management of highly and moderately emetogenic chemotherapy. This study aims to compare the efficacy of NEPA with that of 5HTRA alone in preventing CINV among patients undergoing multiday conditioning chemotherapy prior to HSCT.
PATIENTS AND METHODS
We conducted a retrospective analysis of patients who underwent HSCT between September 2019 and September 2022. Efficacy outcomes were assessed based on the rates of patients achieving complete response (CR: no emesis and no use of rescue medication), complete control (CC: CR without significant nausea), no vomiting, and no significant nausea.
RESULTS
The NEPA group consisted of 106 patients, while the 5HTRA group included 107 patients. The NEPA group exhibited significantly higher rates of CR compared to the 5HTRA group during the overall phase (71.7% vs. 32.7%, P<0.001), acute phase (78.3% vs. 43.0%, P<0.001), and delayed phase (84.9% vs. 58.9%, P<0.001). Similarly, rates of CC, no vomiting, and no significant nausea were significantly better in the NEPA group across all phases (P<0.001).
CONCLUSION
NEPA demonstrated superior efficacy compared to 5HTRA in preventing CINV during all phases of multiday conditioning regimens among patients undergoing HSCT.
PubMed: 38074658
DOI: 10.3389/fonc.2023.1280336 -
Investigational New Drugs Feb 2024Dexamethasone is one of the key antiemetic agents and is widely used even now. However, dexamethasone has been associated with several adverse reactions even after...
Dexamethasone is one of the key antiemetic agents and is widely used even now. However, dexamethasone has been associated with several adverse reactions even after short-term administration. Therefore, developing a steroid-free antiemetic regimen is an important issue to consider. Thus, the purpose of this study was to investigate the efficacy and safety of palonosetron, aprepitant, and olanzapine in a multi-institutional phase II study. Chemotherapy-naive patients scheduled to receive cisplatin were enrolled and evaluated for the occurrence of chemotherapy-induced nausea and vomiting during 120 h after chemotherapy. The primary endpoint of the study was total control (TC) in the overall phase. The key secondary endpoint was complete response (CR), which was assessed in the acute, delayed, and overall phase, respectively. Adverse events were evaluated according to the Common Terminology Criteria for Adverse Events. Eighty-five patients were enrolled from 8 centers in Japan, of which 83 were evaluable for analyses. The percentage of patients who achieved TC during the overall phase was 31.3%. CR was achieved in 61.4%, 84.3%, and 65.1% of patients during the overall, acute, and delayed phases, respectively. The most frequently reported adverse event was anorexia. The primary endpoint was below the threshold and we could not find benefit in the dexamethasone-free regimen, but CR during the overall phase was similar to that of the conventional three-drug regimen. This antiemetic regimen without dexamethasone might be an option for patients for whom corticosteroids should not be an active application.
Topics: Humans; Antiemetics; Aprepitant; Cisplatin; Dexamethasone; Olanzapine; Palonosetron; Pathologic Complete Response
PubMed: 38055127
DOI: 10.1007/s10637-023-01414-y -
Leukemia Research Jan 2024Limited data are available regarding efficacious antiemetic regimens to prevent chemotherapy-induced nausea and vomiting (CINV) for patients undergoing allogeneic...
Evaluation of palonosetron, fosaprepitant, and olanzapine as antiemetic prophylaxis for fludarabine and melphalan-based conditioning regimens prior to allogeneic hematopoietic stem cell transplants.
BACKGROUND
Limited data are available regarding efficacious antiemetic regimens to prevent chemotherapy-induced nausea and vomiting (CINV) for patients undergoing allogeneic hematopoietic stem cell transplant (HSCT). In patients aged 60 years or older, allogeneic HSCT is associated with improved survival, but tolerability of the transplant is a significant barrier. Fludarabine and melphalan (Flu-Mel) is a frequently utilized multi-day reduced intensity conditioning regimen for allogeneic HSCT. However, the optimal CINV prevention regimen is unknown.
OBJECTIVE
The purpose of this study was to evaluate the efficacy of a novel CINV prophylaxis regimen prior to allogeneic HSCT with Flu-Mel compared to a historical control group.
STUDY DESIGN
This was a retrospective, single-center, cohort review of 123 patients who received a Flu-Mel preparative regimen prior to allogeneic HSCT from January 1, 2019, to September 30, 2022. Fifty-nine patients received high dose ondansetron (HDO) for CINV prevention, while sixty-four patients received a combination of palonosetron, fosaprepitant, and olanzapine (PFO). The primary outcome was average number of rescue antiemetic doses administered per day. A key secondary outcome was time to first rescue antiemetic.
RESULTS
The median number of antiemetic doses used per day was significantly lower in patients who received PFO compared to HDO (1.94 doses [0.31-3.60] vs 3.31 doses [1.61-4.92]; p = 0.002). In addition, use of PFO significantly prolonged the median time to first rescue antiemetic compared to HDO (41.3 h [24.3-122.7] vs 26.2 h [14.7-48.1]; p = 0.016).
CONCLUSION
The combination of palonosetron, fosaprepitant, and olanzapine is an effective antiemetic regimen for patients receiving a Flu-Mel-based preparative regimen.
Topics: Humans; Antiemetics; Palonosetron; Olanzapine; Melphalan; Retrospective Studies; Vomiting; Nausea; Ondansetron; Hematopoietic Stem Cell Transplantation; Morpholines; Vidarabine
PubMed: 38043326
DOI: 10.1016/j.leukres.2023.107431 -
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 -
British Journal of Cancer Feb 2024This study evaluated the non-inferiority of dexamethasone (DEX) on day 1, with sparing on days 2-4 in cisplatin-based chemotherapy. (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
This study evaluated the non-inferiority of dexamethasone (DEX) on day 1, with sparing on days 2-4 in cisplatin-based chemotherapy.
METHODS
Patients with malignant solid tumors who were treated with cisplatin (≥50 mg/m²) were randomly assigned (1:1) to receive either DEX on days 1-4 (Arm D4) or DEX on day 1 (Arm D1) plus palonosetron, NK-1 RA, and olanzapine (5 mg). The primary endpoint was complete response (CR) during the delayed (24-120 h) phase. The non-inferiority margin was set at -15%.
RESULTS
A total of 281 patients were enrolled, 278 of whom were randomly assigned to Arm D4 (n = 139) or Arm D1 (n = 139). In 274 patients were included in the efficacy analysis, the rates of delayed CR in Arms D4 and D1 were 79.7% and 75.0%, respectively (risk difference -4.1%; 95% CI -14.1%-6.0%, P = 0.023). However, patients in Arm D1 had significantly lower total control rates during the delayed and overall phases, and more frequent nausea and appetite loss. There were no significant between-arm differences in the quality of life.
CONCLUSION
DEX-sparing is an alternative option for patients receiving cisplatin; however, this revised administration schedule should be applied on an individual basis after a comprehensive evaluation.
CLINICAL TRIALS REGISTRY NUMBER
UMIN000032269.
Topics: Humans; Palonosetron; Cisplatin; Neurokinin-1 Receptor Antagonists; Antiemetics; Olanzapine; Dexamethasone; Vomiting; Quality of Life; Quinuclidines; Antineoplastic Agents
PubMed: 37973958
DOI: 10.1038/s41416-023-02493-7 -
Journal of Exercise Rehabilitation Oct 2023Serotonin syndrome occurs when serotonin (5-hydroxytryptamine, 5-HT) levels increase and is accompanied by symptoms of mental status changes, neuromuscular...
Serotonin syndrome occurs when serotonin (5-hydroxytryptamine, 5-HT) levels increase and is accompanied by symptoms of mental status changes, neuromuscular abnormalities, and autonomic hyperactivity. Serotonin receptor 3 antagonists, such as palonosetron or ramosetron, are commonly used for their antiemetic effects during general anesthesia. However, overdosage of these drugs carries a risk of serotonergic toxicity as they increase serum serotonin levels due to inhibition of serotonin reuptake. Serotonin syndrome caused by 5-HT antagonists is thought to be caused by the synergistic effects of high doses of serotonergic drugs or the combination of two or more serotonergic drugs with different mechanisms of action. The incidence of serotonin syndrome is unknown because it is a rare condition that cannot be selected for in randomized clinical trials. Therefore, physicians must focus on the clinical manifestations of the syndrome and manage patients before the condition becomes life-threatening.
PubMed: 37928825
DOI: 10.12965/jer.2346432.216