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Anesthesia, Essays and Researches 2019In spite of the availability of several antiemetic drugs, postoperative nausea and vomiting (PONV) is very common following laparoscopic surgery. Selective...
Postoperative Nausea and Vomiting Prophylaxis: A Comparative Study of Ramosetron and Palonosetron in Patients Undergoing Laparoscopic Cholecystectomy - A Prospective Randomized Trial.
BACKGROUND
In spite of the availability of several antiemetic drugs, postoperative nausea and vomiting (PONV) is very common following laparoscopic surgery. Selective 5-hydroxytryptamine type 3 receptor antagonists are considered first-line agents for prophylaxis for PONV.
AIMS
In this study, we investigated and compared the efficacy of ramosetron and palonosetron in preventing PONV following laparoscopic cholecystectomy.
STATISTICAL ANALYSIS
The data were analyzed with Student's -test and Chi-square test.
SETTINGS AND DESIGN
This was a randomized, prospective, double-blinded, observational clinical study.
METHODS
A total number of 80 patients, undergoing elective laparoscopic cholecystectomy surgeries under general anesthesia, were randomly assigned to one of the two equal groups to receive either of the following: Group R - received injection ramosetron 0.3 mg and Group - received injection palonosetron 0.075 mg intravenous bolus immediately before the induction of anesthesia. The incidence of PONV, adverse effects of the study drugs, and need for rescue antiemetics were recorded over the next 48 h. Primary outcome was the incidence of PONV. Secondary outcomes were adverse effects of the study drugs and need for rescue.
STATISTICAL ANALYSIS
The data were analyzed with Student's -test and Chi-square test.
RESULTS
The incidence of a complete response (no PONV and no rescue medication) during 0-3 h in the postoperative period was 82.5% with ramosetron and 90% with palonosetron; the incidence during 3-24 h postoperatively was 80% with ramosetron and 87.5% with palonosetron. During 24-48 h, the incidence was 65% and 90%, respectively ( < 0.05). The incidences of adverse effects were statistically insignificant between the groups.
CONCLUSION
Prophylactic therapy with palonosetron is more effective than ramosetron for long-term prevention of PONV following laparoscopic cholecystectomy.
PubMed: 31031483
DOI: 10.4103/aer.AER_192_18 -
Molecules (Basel, Switzerland) Aug 2021Since westernized diet-induced insulin resistance is a risk factor in Alzheimer's disease (AD) development, and lipopolysaccharide (LPS) coexists with amyloid β...
Since westernized diet-induced insulin resistance is a risk factor in Alzheimer's disease (AD) development, and lipopolysaccharide (LPS) coexists with amyloid β (Aβ)1-42 in these patients, our AD novel model was developed to resemble sporadic AD by injecting LPS into high fat/fructose diet (HFFD)-fed rats. The neuroprotective potential of palonosetron and/or methyllycaconitine, 5-HT3 receptor and α7 nAChR blockers, respectively, was evaluated after 8 days of daily administration in HFFD/LPS rats. All regimens improved histopathological findings and enhanced spatial memory (Morris Water Maze); however, palonosetron alone or with methyllycaconitine promoted animal performance during novel object recognition tests. In the hippocampus, all regimens reduced the expression of glial fibrillary acidic protein and skewed microglia M1 to M2 phenotype, indicated by the decreased M1 markers and the enhanced M2 related parameters. Additionally, palonosetron and its combination regimen downregulated the expression of ASC/TMS1, as well as levels of inflammasome downstream molecules and abated cleaved caspase-1, interleukin (IL)-1β, IL-18 and caspase-11. Furthermore, ACh and 5-HT were augmented after being hampered by the insult. Our study speculates that blocking 5-HT3 receptor using palonosetron overrides methyllycaconitine to combat AD-induced neuroinflammation and inflammasome cascade, as well as to restore microglial function in a HFFD/LPS novel model for sporadic AD.
Topics: Aconitine; Alzheimer Disease; Amyloid beta-Peptides; Animals; CARD Signaling Adaptor Proteins; Cognition; Diet, Western; Disease Models, Animal; Hippocampus; Humans; Inflammasomes; Inflammation; Insulin Resistance; Interleukin-18; Lipopolysaccharides; Microglia; Palonosetron; Peptide Fragments; Pyroptosis; Rats; Receptors, Serotonin, 5-HT3; Risk Factors; Spatial Memory
PubMed: 34443654
DOI: 10.3390/molecules26165068 -
Cancer Medicine May 2020To investigate whether palonosetron is better than granisetron in preventing chemotherapy-induced nausea and vomiting (CINV) in a three-drug combination with... (Comparative Study)
Comparative Study Randomized Controlled Trial
A double-blind, randomized, multicenter phase 3 study of palonosetron vs granisetron combined with dexamethasone and fosaprepitant to prevent chemotherapy-induced nausea and vomiting in patients with breast cancer receiving anthracycline and cyclophosphamide.
PURPOSE
To investigate whether palonosetron is better than granisetron in preventing chemotherapy-induced nausea and vomiting (CINV) in a three-drug combination with dexamethasone and fosaprepitant (Fos) in patients with breast cancer who are placed on anthracycline and cyclophosphamide (AC-based regimen).
PATIENTS AND METHODS
Chemo-naive women with primary breast cancer were randomly administered either palonosetron 0.75 mg (day 1) or granisetron 1 mg (day 1) combined with dexamethasone (12 mg at day 1, 8 mg at day 2 and day 3) and Fos 150 mg (day 1) before receiving AC-based regimen in a double-blind study. The primary endpoint was the complete response (CR) rate of emesis in cycle 1 in the delayed phase. This was defined as neither vomiting nor rescue drug usage for emesis at >24-120 hours after chemotherapy. Secondary endpoints were the CR in the acute/overall phase (0-24/0-120 hours, respectively, after chemotherapy), no nausea and vomiting, Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), and safety.
RESULTS
From December 2012 to October 2014, 326 patients were treated and evaluated (164/162 evaluable patients in granisetron/palonosetron arm, respectively). The CR during the delayed phase was 60.4% in the granisetron regimen and 62.3% in the palonosetron regimen. The CR during acute phase (73.2% vs 75.9%, respectively) and the CR during overall phase (54.9% in both regimens) were very identical. A significantly higher number of patients in the palonosetron arm were free from nausea during the delayed phase (28% vs 40.1%; P = .029). Adverse events were also identical, although infusion site reactions (ISR) were higher (20.3%-23.3%) than preceding studies in both regimens.
CONCLUSION
In combination with dexamethasone and Fos, this study suggests that palonosetron is not better than granisetron in chemo-naive patients with primary breast cancer receiving AC-based regimen. Administration of Fos in peripheral veins after AC-based regimen increased ISR.
Topics: Adult; Aged; Aged, 80 and over; Antiemetics; Antineoplastic Combined Chemotherapy Protocols; Breast Neoplasms; Cyclophosphamide; Dexamethasone; Double-Blind Method; Doxorubicin; Drug Therapy, Combination; Epirubicin; Female; Fluorouracil; Granisetron; Humans; Middle Aged; Morpholines; Nausea; Palonosetron; Patient Reported Outcome Measures; Vomiting
PubMed: 32168551
DOI: 10.1002/cam4.2979 -
Core Evidence 2020Antineoplastic drugs may induce several side effects, including chemotherapy-induced nausea and vomiting (CINV). Two neurotransmitters play a central role in mediating... (Review)
Review
INTRODUCTION
Antineoplastic drugs may induce several side effects, including chemotherapy-induced nausea and vomiting (CINV). Two neurotransmitters play a central role in mediating the emetic response: serotonin acting on the 5HT3 receptor and the substance P targeting the NK1 receptor. Indeed, a combination of a 5HT3 receptor antagonist (5HT3-RA) and a NK1 receptor antagonist (NK1-RA) together with dexamethasone has been shown to be very effective. In fact, this combination is actually widely used and recommended for CINV prophylaxis for highly emetogenic cisplatin-based adriamycin/cyclophosphamide (AC) and carboplatin-based regimens. NEPA (netupitant/palonosetron) is the only fixed combination antiemetic available and it is composed by the long-lasting second-generation 5HT3-RA palonosetron and the highly selective NK1-RA netupitant.
AIM
The aims of this short review were to analyze the role of NEPA in CINV prophylaxis and management taking in account the risk factors related to the patient and to the antineoplastic treatment.
EVIDENCE REVIEW
CINV development is not only correlated to the emetogenic potential of the antineoplastic drugs but is also very influenced by the patient characteristics and history, such as gender, age, alcohol intake, nausea during pregnancy and motion sickness. In pivotal and post-registration studies, NEPA has demonstrated to be effective and safe in both highly and moderately emetogenic chemotherapy.
CONCLUSION
A proper assessment of both chemotherapy- and patient-related risk factors is paramount to properly evaluate an appropriate prophylaxis of CINV and NEPA by simplifying the therapy, guarantees fully adherence to antiemetic guidelines, and consequently improves the control of CINV, especially in high risk patients.
PubMed: 32802009
DOI: 10.2147/CE.S203634 -
Oncology (Williston Park, N.Y.) Jul 2007Chemotherapy-induced nausea and vomiting (CINV) remains an important and common toxicity of cancer treatment. Recent guideline revisions have classified chemotherapeutic... (Review)
Review
Chemotherapy-induced nausea and vomiting (CINV) remains an important and common toxicity of cancer treatment. Recent guideline revisions have classified chemotherapeutic agents into four categories of emesis risk without the use of preventive agents: high (> 90%), moderate (30%--90%), low (10%-30%), and minimal (< 10%). Currently available antiemetic agents, including corticosteroids, 5-hydroxytryptamine (HT)3 receptor antagonists, and neurokinin (NK)-1 antagonists are used alone or in combination depending on the level of emetogenic potential as prophylaxis against the development of CINVduring the acute period (up to 24 hours after chemotherapy) and the delayed period (up to 5 days after treatment). Newer agents, including the second-generation 5-HT3 receptor antagonist palonosetron (Aloxi) and the NK-1 antagonist aprepitant (Emend), offer additional clinical benefit in highly and moderately emetogenic therapy. However, delayed nausea and vomiting continue to occur frequently in many patients and have an impact on quality of life. Other classes of agents including the benzodiazepines and cannabinoids offer the potential for additional protective benefit. Continued research with new drugs and combinations is necessary to meet this significant unmet need of cancer patients.
Topics: Antiemetics; Antineoplastic Agents; Cannabinoids; Humans; Nausea; Neurokinin-1 Receptor Antagonists; Serotonin Antagonists; Vomiting
PubMed: 17715696
DOI: No ID Found -
National Journal of Maxillofacial... 2022The objective is to evaluate the efficacy of prophylactic single intravenous dose of palonosetron in the management of postoperative nausea and vomiting (PONV) following...
OBJECTIVE
The objective is to evaluate the efficacy of prophylactic single intravenous dose of palonosetron in the management of postoperative nausea and vomiting (PONV) following oral and maxillofacial surgical interventions performed through an intraoral approach under general anesthesia (GA).
MATERIALS AND METHODS
A prospective study was conducted on 100 subjects who underwent intraoral surgical procedures for the management of maxillofacial trauma, pathology, dentofacial anomalies, and deformities under GA. All subjects received a prophylactic single intravenous dose of 0.075 mg palonosetron along with premedication. Predisposing factors for PONV such as patient age, gender, Apfel risk score, history of motion sickness, smoking, type of procedure, and administration of postoperative opioids were taken into consideration. All the patients were monitored for PONV for the 1 24 h postoperatively (PO). First, at an interval of 30 min for 1 4 h and then at every 2 h interval for next 8 h followed by monitoring every 6 h interval till 24 h. Time and frequency of rescue medication were noted.
RESULTS
Seventy-nine percentage subjects did not have PONV. 15% subjects had a single episode of vomiting PO which could be attributed to multiple intra oral surgical sites performed as well as longer duration of exposure to anesthetic agents in addition to providing opioid analgesics for the management of postoperative pain. Only 6% subjects needed rescue antiemetic drug. Palonosetron did not show any significant changes in cardiac status and serum profile.
CONCLUSION
Palonosetron is effective in the management of PONV for maxillofacial surgical procedures performed through an intraoral approach under GA.
PubMed: 36051795
DOI: 10.4103/njms.NJMS_346_21 -
European Review For Medical and... Aug 2021The outbreak of coronavirus disease 2019 (COVID-19) has affected the treatment of cancer patients, with particular regard to the management of both chemotherapy and side...
NEPA (netupitant/palonosetron) for the antiemetic prophylaxis of nausea and vomiting induced by chemotherapy (CINV) with Folfirinox and Folfoxiri even during the COVID-19 pandemic: a real-life study.
OBJECTIVE
The outbreak of coronavirus disease 2019 (COVID-19) has affected the treatment of cancer patients, with particular regard to the management of both chemotherapy and side effects. Chemotherapy-induced nausea and vomiting (CINV) are amongst the most troublesome side effects that impair patients' adherence to treatments and their quality of life (QoL). NEPA (Akynzeo®), is an oral fixed-dose combination of netupitant [a neurokinin-1 receptor antagonist (NK1RA), 300 mg] and palonosetron [(5-hydroxytryptamine (serotonin or 5HT) type3 receptor antagonist (5HT3RA), 0.5 mg] which has been shown to be effective in preventing CINV.
PATIENTS AND METHODS
This prospective study started before the outbreak of COVID-19 and was carried out during the pandemic period. The aim was to evaluate the efficacy and safety of a single oral dose NEPA plus 12 mg of dexamethasone (DEX) in patients treated with Folfoxiri plus Bevacizumab and Folfirinox. The patients were diagnosed with advanced colorectal cancer (CRC) or advanced pancreatic ductal adenocarcinoma (PDAC). They were divided into two groups: naïve patients and patients previously treated with serotonin receptor antagonists (5HT3-RA) and neurokin-1 receptor antagonists (NK1-RA).
RESULTS
During the overall phase, the complete response (CR) rate was 96.8% in naïve patients treated with Folfoxiri plus Bevacizumab, and 94.6% in patients treated with Folfirinox. During the acute and delayed phases, the CR rate was 92.8% and 94.2%, with Folfoxiri and Bevacizumab, as well as 96.2% and 94.6%, with Folfirinox. There was no adequate control of CINV events in patients on antiemetic prophylaxis with 5HT3-RA or NK1-RA associated with cortisone. During the overall phase, the CR rate was 74.6% with Folfoxiri plus Bevacizumab and 75.8% with Folfirinox. During the acute and delayed phases, the CR rate was 72.5% and 74.8% with Folfoxiri plus Bevacizumab, as well as 75.2% and 74.6% with Folfirinox.
CONCLUSIONS
This study has shown the therapeutic benefits of NEPA in the management and prophylaxis of CINV events, both in naive patients and patients previously treated with 5HT3-RA and NK1-RA. In addition, NEPA has been shown to be safe, both before and during the COVID-19 pandemic.
Topics: Aged; Antiemetics; Antineoplastic Combined Chemotherapy Protocols; Bevacizumab; COVID-19; Colorectal Neoplasms; Female; Fluorouracil; Humans; Irinotecan; Leucovorin; Male; Middle Aged; Nausea; Oxaliplatin; Palonosetron; Pandemics; Prospective Studies; Pyridines; Vomiting
PubMed: 34486707
DOI: 10.26355/eurrev_202108_26552 -
Biological & Pharmaceutical Bulletin 2017In the present study, the antiemetic effect of palonosetron, not combined with dexamethasone and aprepitant, on chemotherapy-induced nausea and vomiting was evaluated in... (Comparative Study)
Comparative Study
In the present study, the antiemetic effect of palonosetron, not combined with dexamethasone and aprepitant, on chemotherapy-induced nausea and vomiting was evaluated in patients with malignant lymphoma receiving first-line rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) therapy, and was compared to that of granisetron. A total of 74 patients with non-Hodgkin lymphoma were included in this study (April 2007 to December 2015). Palonosetron (0.75 mg) or granisetron (3 mg) was intravenously administered before R-CHOP therapy. The proportions of patients with complete response (CR) during the overall (0-120 h after the start of R-CHOP therapy), acute (0-24 h) and delayed (24-120 h) phases were evaluated. CR was defined as no vomiting and no use of antiemetic rescue medication. A total of 32 and 42 patients were treated with palonosetron and granisetron, respectively. The CR rate in the palonosetron group was significantly higher than that in the granisetron group during the delayed phase (90.6 and 61.9%, respectively; p=0.007). Logistic regression analysis showed that use of palonosetron improved the CR rate during the delayed phase, compared to use of granisetron. Female sex, age less than 60 years, no habitual alcohol intake, and Eastern Cooperative Oncology Group performance status (ECOG-PS) score of 1 were significant risk factors associated with non-CR. The findings of this study suggested the superiority of palonosetron to granisetron, without accompanying dexamethasone and aprepitant, for chemotherapy-induced nausea and vomiting in patients with malignant lymphoma.
Topics: Adult; Aged; Aging; Antibodies, Monoclonal, Murine-Derived; Antiemetics; Antineoplastic Combined Chemotherapy Protocols; Asian People; Cyclophosphamide; Doxorubicin; Female; Granisetron; Humans; Isoquinolines; Lymphoma, Non-Hodgkin; Male; Middle Aged; Nausea; Palonosetron; Prednisone; Quinuclidines; Risk Factors; Rituximab; Sex Characteristics; Treatment Outcome; Vincristine; Vomiting; Young Adult
PubMed: 28867732
DOI: 10.1248/bpb.b17-00318 -
Cancer Management and Research 2014Prevention of chemotherapy-induced nausea and vomiting (CINV) is a key component of treatment for patients with cancer. Guidelines are available to assist prescribers in... (Review)
Review
Prevention of chemotherapy-induced nausea and vomiting (CINV) is a key component of treatment for patients with cancer. Guidelines are available to assist prescribers in the management of CINV associated with single-day chemotherapy regimens. However, currently there are no clear guidelines for management of CINV in patients receiving multiple-day chemotherapy regimens. Serotonin (5-HT3) receptor antagonists are a mainstay in preventing CINV, and palonosetron, given its longer half-life and duration of action relative to other 5-HT3 receptor antagonists, may be a useful option for managing CINV in multiple-day chemotherapy. Here we provide an overview of CINV and CINV treatment options, with a focus on palonosetron. We describe existing challenges in managing CINV, and discuss two patients receiving multiple-day chemotherapy, in whom CINV was managed successfully with palonosetron.
PubMed: 25228819
DOI: 10.2147/CMAR.S68102 -
International Journal of Medical... 2018: The efficacy of dexamethasone plus palonosetron for postoperative nausea and vomiting (PONV) prophylaxis is not firmly established. This randomized, double-blind,... (Randomized Controlled Trial)
Randomized Controlled Trial
Efficacy of Palonosetron-Dexamethasone Combination Versus Palonosetron Alone for Preventing Nausea and Vomiting Related to Opioid-Based Analgesia: A Prospective, Randomized, Double-blind Trial.
: The efficacy of dexamethasone plus palonosetron for postoperative nausea and vomiting (PONV) prophylaxis is not firmly established. This randomized, double-blind, controlled study evaluated whether the combination was superior to palonosetron alone in preventing PONV in patients receiving intravenous patient-controlled analgesia (IV-PCA) after upper extremity surgery. : A total of 202 patients undergoing upper extremity surgery were randomly assigned to group P (palonosetron alone) or group PD (palonosetron plus dexamethasone). Group P patients received palonosetron 0.075 mg and normal saline 1.6 mL; group PD patients received palonosetron 0.075 mg and dexamethasone 8 mg. In both groups, palonosetron was added to the IV-PCA opioid infusion, which was continued for 48 h postoperatively. Incidence and severity of nausea, incidence of vomiting, rescue antiemetic requirements, pain intensity, and rescue analgesic requirements were evaluated for 72 h postoperatively. Quality of recovery was assessed using the quality of recovery-15 (QoR-15) questionnaire. The incidence of PONV was significantly lower in group PD than in group P at 0-48 h postoperatively (61.5% vs 77.1%; p = 0.019). Severity of nausea at 0-6 h postoperatively was significantly less in group PD compared with group P (none/mild/moderate/severe: 49/22/15/10 vs. 36/16/25/19, p = 0.008). The incidence of vomiting and rescue antiemetic requirements were similar between groups. Pain intensity was significantly less in group PD than in group P at 0-48 h and 48-72 h postoperatively. Global QoR-15 was similar 24 h postoperatively between groups. : Dexamethasone-palonosetron combination therapy reduced PONV incidence and postoperative pain in patients receiving opioid-based analgesia after upper extremity surgery.
Topics: Adult; Aged; Analgesics, Opioid; Antiemetics; Dexamethasone; Double-Blind Method; Female; Humans; Male; Middle Aged; Nausea; Palonosetron; Prospective Studies; Vomiting
PubMed: 30013436
DOI: 10.7150/ijms.24230