-
Supportive Care in Cancer : Official... Nov 2022The aim of this study was to assess the cost-effectiveness of NEPA, a fixed-dose combination of oral netupitant (300 mg) and palonosetron (0.5 mg), compared to...
Cost-effectiveness analysis of NEPA, a fixed-dose combination of netupitant and palonosetron, for the prevention of highly emetogenic chemotherapy-induced nausea and vomiting: an international perspective.
PURPOSE
The aim of this study was to assess the cost-effectiveness of NEPA, a fixed-dose combination of oral netupitant (300 mg) and palonosetron (0.5 mg), compared to available treatments in Spain after aprepitant generic introduction in the market, and to discuss results in previously performed analyses in different wordwide settings.
METHODS
A Markov model including three health states, complete protection, complete response at best and incomplete response, was used to evaluate the cost-effectiveness of NEPA versus common treatment options in Spain during 5 days after chemotherapy. Incremental costs including treatment costs and treatment failure management cost as well as incremental effects including quality adjusted life days (QALDs) and emesis-free days were compared between NEPA and the comparator arms. The primary outcomes were cost per avoided emetic event and cost per QALDs gained.
RESULTS
NEPA was dominant (more effective and less costly) against aprepitant combined with palonosetron, and fosaprepitant combined with granisetron, while, compared to generic aprepitant plus ondansetron, NEPA showed an incremental cost per avoided emetic event of €33 and cost per QALD gained of €125.
CONCLUSION
By most evaluations, NEPA is a dominant or cost-effective treatment alternative to current antiemetic standards of care in Spain during the first 5 days of chemotherapy treatment in cancer patients, despite the introduction of generics. These results are in line with previously reported analyses throughout different international settings.
Topics: Humans; Palonosetron; Cost-Benefit Analysis; Aprepitant; Emetics; Vomiting; Antineoplastic Agents; Nausea; Antiemetics; Internationality; Quinuclidines
PubMed: 36074186
DOI: 10.1007/s00520-022-07339-1 -
Journal of Anaesthesiology, Clinical... 2019The present study evaluated the effects of two 5-HT3 serotonin receptor antagonists; granisetron and palonosetron on hemodynamics, sensory, and motor blockade induced by...
Comparison of IV granisetron and IV palonosetron on hemodynamics and sensory and motor block after spinal anesthesia with hyperbaric bupivacaine in patients undergoing abdominal hysterectomy.
BACKGROUND AND AIMS
The present study evaluated the effects of two 5-HT3 serotonin receptor antagonists; granisetron and palonosetron on hemodynamics, sensory, and motor blockade induced by intrathecal bupivacaine in patients undergoing abdominal hysterectomy.
MATERIAL AND METHODS
In total, 126 female patients (ASA I and II physical status) undergoing abdominal hysterectomy under spinal anesthesia with intrathecal bupivacaine were randomly divided into three groups out of which 40 patients in each group were evaluated for final outcome. Group G received intravenous 1 mg granisetron, group P received intravenous palonosetron 0.075 mg, and group C received intravenous normal saline. Study drug was given 5 min before the spinal anesthesia. Systolic, diastolic and mean arterial blood pressure, heart rate, sensory and motor blockade were assessed.
RESULTS
The systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate showed no significant differences among the three groups. Time to reach peak sensory block and modified Bromage 3 motor block, time to two segmental regression of sensory block, and motor regression to modified Bromage score of 0 were not statistically different among the three groups. Although statistically significant early regression of sensory block to segment S1 was seen in group G as compared to group P and group C, it was of no clinical significance. The incidence of nausea and vomiting was significantly lower in group G and P.
CONCLUSION
Intravenous administration of granisetron and palonosetron before intrathecal bupivacaine does not attenuate the hemodynamic changes in patients undergoing abdominal hysterectomy. Further, both 5-HT3 receptors antagonists do not have clinically significant effects on the spinal blockade produced by hyperbaric bupivacaine.
PubMed: 31303705
DOI: 10.4103/joacp.JOACP_334_17 -
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 -
Anesthesia, Essays and Researches 2019Laparoscopic cholecystectomy (LC) is associated with high risk of postoperative nausea and vomiting (PONV) if no prophylactic antiemetic is used.
Comparison of Palonosetron and Dexamethasone with Ondansetron and Dexamethasone to Prevent Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy.
BACKGROUND
Laparoscopic cholecystectomy (LC) is associated with high risk of postoperative nausea and vomiting (PONV) if no prophylactic antiemetic is used.
AIMS
The study compared prophylactic palonosetron and dexamethasone with ondansetron and dexamethasone in patients undergoing LC.
SETTING AND DESIGN
This prospective, double-blinded, randomized, controlled study was conducted at a tertiary care center.
MATERIALS AND METHODS
The study was carried out in 86 patients who underwent LC. The patients were randomly assigned to following study groups: Group 1 who received palonosetron (0.75 mg) with dexamethasone (8 mg) and Group II who received ondansetron (4 mg) with dexamethasone (8 mg). Patients were observed for nausea with visual analog scale and vomiting episode during 48 h postoperative follow-up.
STATISTICAL ANALYSIS USED
Data were analyzed as mean, standard deviation, percentage, and number. The following statistical tests were used: paired or unpaired -test, Mann-Whitney test, Chi-square test, and repeated ANOVA test.
RESULTS
There was no statistically significant difference in heart rate, mean arterial pressure, and oxygen saturation from baseline. During 48 h follow-up, the incidence of nausea, vomiting, and PONV was higher in Group II, but the difference was not statistically significant. The total dose of rescue antiemetic was 2.14 ± 4.15 mg in Group I and 5.00 ± 8.62 mg in Group II patients ( = 0.058). Headache was present in three patients in Group I and two patients of Group II.
CONCLUSION
The palonosetron with dexamethasone is comparable to ondansetron with dexamethasone in the prevention of PONV in patients undergoing LC.
PubMed: 31198253
DOI: 10.4103/aer.AER_21_19 -
Journal of Clinical Oncology : Official... Feb 2016To update a key recommendation of the American Society of Clinical Oncology antiemetic guideline. This update addresses the use of the oral combination of netupitant (a...
PURPOSE
To update a key recommendation of the American Society of Clinical Oncology antiemetic guideline. This update addresses the use of the oral combination of netupitant (a neurokinin 1 [NK1] receptor antagonist) and palonosetron (a 5-hydroxytryptamine-3 [5-HT3] receptor antagonist) for the prevention of acute and delayed nausea and vomiting in patients receiving chemotherapy.
METHODS
An update committee conducted a targeted systematic literature review and identified two phase III clinical trials and a randomized phase II dose-ranging study.
RESULTS
In one phase III trial, the oral combination of netupitant and palonosetron was associated with higher complete response rates (no emesis and no rescue medications) compared with palonosetron alone in patients treated with anthracycline plus cyclophosphamide chemotherapy (74% v 67% overall; P = .001). In another phase III trial, the oral combination of netupitant and palonosetron was safe and effective across multiple cycles of moderately or highly emetogenic chemotherapies. In the phase II dose-ranging study, each dose of netupitant (coadministered with palonosetron 0.50 mg) produced higher complete response rates than palonosetron alone among patients receiving cisplatin-based chemotherapy. The highest dose of netupitant (ie, 300 mg) was most effective.
RECOMMENDATIONS
All patients who receive highly emetogenic chemotherapy regimens (including anthracycline plus cyclophosphamide) should be offered a three-drug combination of an NK1 receptor antagonist, a 5-HT3 receptor antagonist, and dexamethasone. The oral combination of netupitant and palonosetron plus dexamethasone is an additional treatment option in this setting. The remaining recommendations from the 2011 ASCO guideline are unchanged pending a full update. Additional information is available at www.asco.org/guidelines/antiemetics and www.asco.org/guidelineswiki.
Topics: Antiemetics; Antineoplastic Combined Chemotherapy Protocols; Clinical Trials, Phase II as Topic; Clinical Trials, Phase III as Topic; Humans; Nausea; Randomized Controlled Trials as Topic; Vomiting
PubMed: 26527784
DOI: 10.1200/JCO.2015.64.3635 -
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 -
International Journal of Hematology Apr 2017Chemotherapy-induced nausea and vomiting (CINV) is a significant side effect in multiple myeloma (MM) patients receiving high-dose melphalan treatment followed by...
Palonosetron, aprepitant, and dexamethasone for prevention of nausea and vomiting after high-dose melphalan in autologous transplantation for multiple myeloma: A phase II study.
Chemotherapy-induced nausea and vomiting (CINV) is a significant side effect in multiple myeloma (MM) patients receiving high-dose melphalan treatment followed by autologous stem cell transplantation (ASCT). We evaluated the efficacy and safety of a triple antiemetic combination of palonosetron, aprepitant, and low-dose dexamethasone in 24 MM patients who received melphalan conditioning (100 mg/m on days 1-2) before ASCT (on day 4). Intravenous palonosetron (0.75 mg on day 1), oral aprepitant (125 mg on day 1; 80 mg on days 2-4), and intravenous dexamethasone (6.6 mg on days 1-4) were administered for prevention of CINV. Complete response (no emesis and no rescue antiemetic) and complete control (no emesis, no rescue antiemetic, and no more than mild nausea) rates were 75 and 68% during the overall phase (0-120 h), while they were 88 and 86% in the acute phase (0-48 h), 75 and 68% in the delayed phase (48-120 h), and 67 and 59% in the extended phase (120-168 h), respectively. There were no serious adverse events related to the antiemetic therapy. In conclusion, the three-antiemetic regimen consisting of palonosetron, aprepitant, and dexamethasone was safe and effective for controlling CINV due to high-dose melphalan treatment, especially during the delayed phase.
Topics: Adult; Aged; Antiemetics; Aprepitant; Dexamethasone; Drug Therapy, Combination; Humans; Isoquinolines; Melphalan; Middle Aged; Morpholines; Multiple Myeloma; Myeloablative Agonists; Palonosetron; Postoperative Nausea and Vomiting; Quinuclidines; Transplantation, Autologous; Treatment Outcome
PubMed: 27873176
DOI: 10.1007/s12185-016-2152-6 -
Journal of Pharmaceutical Health Care... 2018Antiemetic effects and safety of granisetron or palonosetron alone and in combination with a corticosteroid against chemotherapy-induced nausea and vomiting (CINV) were...
BACKGROUND
Antiemetic effects and safety of granisetron or palonosetron alone and in combination with a corticosteroid against chemotherapy-induced nausea and vomiting (CINV) were retrospectively evaluated in patients with Hodgkin lymphoma receiving adriamycin, bleomycin, vinblastine, and dacarbazine (ABVD) therapy.
METHODS
A total of 39 patients were eligible for this study. Before ABVD therapy, granisetron or palonosetron was intravenously administered with or without a corticosteroid (dexamethasone or hydrocortisone) and aprepitant. The proportions of patients with complete control (CC) during the overall (0-120 h after the start of ABVD therapy), acute (0-24 h) and delayed (24-120 h) phases were evaluated. CC was defined as no vomiting and no use of antiemetic rescue medication with only grade 0-1 nausea.
RESULTS
Granisetron and palonosetron were administered in 21 and 18 patients, respectively. The CC rate during the acute, delayed and overall phases was not statistically different between the two groups. The CINV was completely controlled during overall phase in 58.3% of patients receiving granisetron or palonosetron in combination with a corticosteroid, whereas in 11.1% of those without co-treatment of a corticosteroid ( < 0.05). There were significantly higher frequencies of anorexia, leucopenia and neutropenia in the palonosetron group. There is a statistically significant difference in the frequency of febrile neutropenia between presence and absence of a corticosteroid ( = 0.024).
CONCLUSION
These findings suggested that a combination use of a corticosteroid with a 5-HT receptor antagonist was preferable for CINV control in patients with Hodgkin lymphoma receiving ABVD therapy, although the careful management of febrile neutropenia is required.
TRIAL REGISTRATION
The study approval numbers in the institution; 24-12 and 24-359. Registered April 17, 2012 and June 21, 2012.
PubMed: 29345696
DOI: 10.1186/s40780-017-0097-4 -
Drugs Dec 2016An extended-release (ER) subcutaneously injectable formulation of the first-generation 5-HT receptor antagonist granisetron is now available in the USA (Sustol), where... (Review)
Review
An extended-release (ER) subcutaneously injectable formulation of the first-generation 5-HT receptor antagonist granisetron is now available in the USA (Sustol), where it is indicated for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) following moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide combination chemotherapy regimens in adults. Granisetron ER is administered as a single subcutaneous injection and uses an erosion-controlled drug-delivery system to allow prolonged granisetron release. Primary endpoint data from phase III studies after an initial cycle of chemotherapy indicate that, when used as part of an antiemetic regimen, granisetron ER injection is more effective than intravenous ondansetron in preventing delayed CINV following highly emetogenic chemotherapy (HEC); is noninferior to intravenous palonosetron in preventing both acute CINV following MEC or HEC and delayed CINV following MEC; and is similar, but not superior, to palonosetron in preventing delayed CINV following HEC. The benefits of granisetron ER were seen in various patient subgroups, including those receiving anthracycline plus cyclophosphamide-based HEC, and (in an extension of one of the studies) over multiple MEC or HEC cycles. Granisetron ER injection is generally well tolerated, with an adverse event profile similar to that of ondansetron or palonosetron. Thus, granisetron ER injection expands the options for preventing both acute and delayed CINV in adults with cancer receiving MEC or anthracycline plus cyclophosphamide-based HEC.
Topics: Animals; Antiemetics; Antineoplastic Agents; Delayed-Action Preparations; Granisetron; Humans; Injections; Nausea; Neoplasms; Vomiting
PubMed: 27915445
DOI: 10.1007/s40265-016-0664-2 -
Lung Cancer (Amsterdam, Netherlands) Dec 2015Although antiemetic management has improved, better control of chemotherapy-induced nausea and vomiting (CINV), particularly during the delayed phase, is needed. The... (Clinical Trial)
Clinical Trial Randomized Controlled Trial
Evaluation of palonosetron and dexamethasone with or without aprepitant to prevent carboplatin-induced nausea and vomiting in patients with advanced non-small-cell lung cancer.
OBJECTIVES
Although antiemetic management has improved, better control of chemotherapy-induced nausea and vomiting (CINV), particularly during the delayed phase, is needed. The benefit of combination therapy using dexamethasone and the second-generation 5-hydroxytryptamine-3 receptor antagonist palonosetron compared with that of other such receptor antagonists in carboplatin-based chemotherapy is unclear. The effectiveness of adding aprepitant for CINV treatment in moderate emetogenic chemotherapy is also unknown. We compared the efficacy and safety of triple antiemetic therapy using aprepitant, palonosetron, and dexamethasone with that of double antiemetic therapy using palonosetron and dexamethasone in patients with advanced non-small-cell lung cancer receiving carboplatin-containing chemotherapy.
METHODS
Chemotherapy-naïve patients with non-small-cell lung cancer were enrolled in this prospective controlled study. Eighty patients were randomly assigned to groups receiving either double antiemetic therapy with palonosetron and dexamethasone, or triple antiemetic therapy with aprepitant, palonosetron, and dexamethasone. Complete response rate (no vomiting episode and no rescue therapy) was evaluated as the primary endpoint during the 5-day post-chemotherapy period.
RESULTS
The aprepitant add-on and double therapy groups showed overall complete response rates of 80.5% (95% confidence interval [CI]: 68.4-92.6%) and 76.9% (95% CI: 63.7-90.1%; odds ratio [OR]: 0.81; 95% CI; 0.27-2.36; p=0.788), respectively. Complete responses in the acute and delayed phases and overall incidences of treatment-related adverse events were similar between groups.
CONCLUSION
According to the selection design, triple antiemetic therapy with aprepitant, palonosetron, and dexamethasone was not considered as an option for further studies.
Topics: Adult; Aged; Aged, 80 and over; Antiemetics; Antineoplastic Combined Chemotherapy Protocols; Carboplatin; Carcinoma, Non-Small-Cell Lung; Dexamethasone; Female; Humans; Isoquinolines; Lung Neoplasms; Male; Middle Aged; Nausea; Neoplasm Staging; Odds Ratio; Palonosetron; Quinuclidines; Treatment Outcome; Vomiting
PubMed: 26791800
DOI: 10.1016/j.lungcan.2015.11.009