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Cancer Chemotherapy and Pharmacology Jul 2021Chemotherapy-induced nausea and vomiting (CINV) is considered one of the most serious adverse events affecting chemotherapy-receiving cancer patients. It dramatically... (Randomized Controlled Trial)
Randomized Controlled Trial
Evaluation of clinical outcomes and efficacy of palonosetron and granisetron in combination with dexamethasone in Egyptian patients receiving highly emetogenic chemotherapy.
BACKGROUND
Chemotherapy-induced nausea and vomiting (CINV) is considered one of the most serious adverse events affecting chemotherapy-receiving cancer patients. It dramatically affects their food intake, nutritional status and more importantly their quality of life. We can observe CINV in highly emetogenic chemotherapy (HEC) such as adriamycin-cyclophosphamide combination (AC) in breast cancer patients and cisplatin-based regimens in other cancer types. This study aimed to evaluate the antiemetic efficacy of palonosetron (PALO) over granisetron (GRA) in combination with dexamethasone for multiple highly emetogenic chemotherapy drugs (HEC), especially in chemotherapy regimens in Egyptian breast cancer patients and cisplatin-based regimens in other diseases.
PATIENTS AND METHODS
An open-label randomized trial was carried out, including 115 patients receiving at least four cycles of highly emetogenic chemotherapy regimens. All patients received dexamethasone in combination with the 5-HT3 receptor antagonist. We recorded patients' clinical and biochemical characteristics and withdraw blood samples to monitor serum substance P and serotonin in correlation with chemotherapy-induced nausea and vomiting (CINV). We use the MASCC antiemetic tool in the acute phase (0-24 hr) and delayed phase (24-120 h) to evaluate patient outcomes in both stages after each chemotherapy cycle.
RESULTS
In (PALO) group, only 7.84% of patients showed acute vomiting, and 11.76% showed acute nausea, whereas 43.75% of patients showed acute vomiting and 89.06% showed acute nausea in (GRA) group (P < 0.0001). For delayed CINV, 23.53% of patients showed delayed vomiting, and 47.06% showed delayed nausea in the (PALO) group, while 82.81% of patients showed delayed emesis, and 92.19% showed delayed nausea in (GRA) group (P < 0.0001). The study showed that PALO is a cost-effective choice when compared to GRA in CINV prevention as 45.10% of patients in (PALO) required additional rescue medications (Domperidone 10 mg orally three times per day plus Trimebutine 200 mg orally three times per week both for 5 days), while 95.24% in the (GRA) group used the same medications. Adverse events of both antiemetic drugs (PALO and GRA) include headaches and constipation and QTc prolongation reports, mostly mild to moderate, with relatively low rates among the two groups.
CONCLUSION
Palonosetron, combined with dexamethasone, is more effective than granisetron and dexamethasone combination against both acute and delayed emesis induced by highly emetogenic chemotherapy (HEC) cisplatin-based protocols and the combination of cyclophosphamide and anthracyclines (AC). Medical team members should make more efforts, especially clinical pharmacy personnel, to monitor medications' effectiveness and help the medical team achieve a suitable and reliable care plan.
Topics: Antiemetics; Antineoplastic Agents; Aprepitant; Cisplatin; Cyclophosphamide; Dexamethasone; Doxorubicin; Drug Therapy, Combination; Egypt; Female; Granisetron; Humans; Male; Middle Aged; Nausea; Palonosetron; Quality of Life; Vomiting
PubMed: 33835230
DOI: 10.1007/s00280-021-04257-7 -
Brazilian Journal of Anesthesiology... 2024End-stage renal diseases patients have a high risk of postoperative nausea and vomiting (PONV), which is multifactorial and need acute attention after renal... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
End-stage renal diseases patients have a high risk of postoperative nausea and vomiting (PONV), which is multifactorial and need acute attention after renal transplantation for a successful outcome in term of an uneventful postoperative period. The study was done to compare the efficacy of palonosetron and ondansetron in preventing early and late-onset PONV in live donor renal transplantation recipients (LDRT).
METHODS
The prospective randomized double-blinded study was done on 112 consecutive patients planned for live donor renal transplantation. Patients of both sexes in the age group of 18...60 years were randomly divided into two groups: Group O (Ondansetron) and Group P (Palonosetron) with 56 patients in each group by computer-generated randomization. The study drug was administered intravenously (IV) slowly over 30.ßseconds, one hour before extubation. Postoperatively, the patients were accessed for PONV at 6, 24, and 72.ßhours using the Visual Analogue Scale (VAS) nausea score and PONV intensity scale.
RESULTS
The incidence of PONV in the study was found to be 30.35%. There was significant difference in incidence of PONV between Group P and Group O at 6.ßhours (12.5% vs. 32.1%, p.ß=.ß0.013) and 72.ßhours (1.8% vs. 33.9%, p.ß<.ß0.001), but insignificant difference at 24.ßhours (1.8% vs. 10.7%, p.ß=.ß0.113). VAS-nausea score was significantly lower in Group P as compared to Group O at a time point of 24.ßhours (45.54.ß...ß12.64 vs. 51.96.ß...ß14.70, p.ß=.ß0.015) and 72.ßhours (39.11.ß...ß10.32 vs. 45.7.ß...ß15.12, p.ß=.ß0.015).
CONCLUSION
Palonosetron is clinically superior to ondansetron in preventing early and delayed onset postoperative nausea and vomiting in live-related renal transplant recipients.
Topics: Male; Female; Humans; Adolescent; Palonosetron; Ondansetron; Postoperative Nausea and Vomiting; Antiemetics; Kidney Transplantation; Prospective Studies; Double-Blind Method
PubMed: 34411635
DOI: 10.1016/j.bjane.2021.07.027 -
Obesity Surgery Sep 2019Post intragastric balloon placement symptoms like nausea and vomiting have been the major cause of a high rate of early removal. Common therapy with ondansetron alone,...
BACKGROUND
Post intragastric balloon placement symptoms like nausea and vomiting have been the major cause of a high rate of early removal. Common therapy with ondansetron alone, or in combination, with prokinetic agents have been shown to have very little or no effect. Recently, an improved therapy based on aprepitant and ondansetron combination showed a significant improvement in symptoms management. Lack of aprepitant availability in several countries and patients difficulties to follow the right prescription convinced us to explore other pharmacological options.
OBJECTIVE
Evaluate safety and efficacy of a netupitant and palonosetron-combined drug and to reduce and control post Elipse® placement symptoms METHODS: Between January and March 2018, 30 patients (9 male, 21 female), (mean weight 97.8 and mean BMI 34.7), underwent Elispe® placements, at 550 ml volume, in an outpatient fashion. All patients received a single pill 300 mg netupitant/0.5 mg palonosetron 6 h prior to placement. All patients received ondansetron 4 mg prescription to be taken as needed. A daily VAS score to report intensity of nausea, vomit, cramps, gastric pain, satiety for the first week post-placement was completed.
RESULTS
4/30 (13%) reported vomiting on days 1, 2, and 3; 9/30 (30%) reported nausea higher than score 4 on days 1, 2, and 3; 8/30 (26.6%) reported gastric pain higher than score 4 on days 1, 2, and 3.
CONCLUSION
In our experience, the use of a single-pill netupitant/palonosetron resulted to be very easy to administer and effective in reducing vomit, nausea, and gastric pain in 87%, 70%, and 73.4% patients respectively, ameliorating the post Elipse™ placements symptoms safely.
Topics: Adult; Antiemetics; Female; Gastric Balloon; Humans; Male; Middle Aged; Obesity, Morbid; Ondansetron; Palonosetron; Postoperative Nausea and Vomiting; Pyridines
PubMed: 31104280
DOI: 10.1007/s11695-019-03937-x -
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 -
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 -
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 -
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 -
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