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Drug Design, Development and Therapy 2019Chemotherapy-induced nausea and vomiting (CINV) are a major burden for patients undergoing emetogenic chemotherapy. International guidelines recommend an antiemetic... (Observational Study)
Observational Study
BACKGROUND
Chemotherapy-induced nausea and vomiting (CINV) are a major burden for patients undergoing emetogenic chemotherapy. International guidelines recommend an antiemetic prophylaxis with corticosteroids, 5-HTR-antagonists and NKR-antagonists. The NKR-antagonist fosaprepitant has shown favorable results in pediatric and adult patients. There is little pediatric experience with fosaprepitant.
METHODS
This non-interventional observation study analyzed 303 chemotherapy courses administered to 83 pediatric patients with a median age of 9 years (2-17 years), who received antiemetic prophylaxis either with fosaprepitant and granisetron with or without dexamethasone (fosaprepitant group/FG; n=41), or granisetron with or without dexamethasone (control group/CG; n=42), during moderately (CINV risk 30-90%) or highly (CINV risk>90%) emetogenic chemotherapy. The two groups' results were compared with respect to the safety and efficacy of the antiemetic prophylaxis during the acute (0-24hrs after chemotherapy), delayed (>24-120hrs after chemotherapy) and both CINV phases. Laboratory and clinical adverse events were compared between the two cohorts.
RESULTS
Adverse events were not significantly different in the two groups (p>0.05). Significantly fewer vomiting events occurred during antiemetic prophylaxis with fosaprepitant in the acute (23 vs 142 events; p<0.0001) and the delayed (71 vs 255 events; p<0.0001) CINV phase. In the control group, the percentage of chemotherapy courses with vomiting was significantly higher during the acute (24%/FG vs 45%/CG; p<0.0001) and delayed CINV phase (28%/FG vs 47%/CG; p=0.0004). Dimenhydrinate (rescue medication) was administered significantly more often in the CG, compared to the FG (114/FG vs 320/CG doses; p<0.0001). Likewise, in the control group, dimenhydrinate was administered in significantly more (p<0.0001) chemotherapy courses during the acute and delayed CINV phases (79 of 150; 52.7%), compared to the fosaprepitant group (45 of 153; 29.4%).
CONCLUSION
Antiemetic prophylaxis with fosaprepitant and granisetron with or without dexamethasone was well tolerated, safe and effective in pediatric patients. However, larger prospective trials are needed to evaluate these findings.
Topics: Adolescent; Antiemetics; Antineoplastic Combined Chemotherapy Protocols; Child; Child, Preschool; Cohort Studies; Dexamethasone; Drug Therapy, Combination; Female; Granisetron; Humans; Male; Morpholines; Nausea; Vomiting
PubMed: 31686784
DOI: 10.2147/DDDT.S214264 -
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 -
BMC Anesthesiology May 2023Postoperative nausea and vomiting (PONV) is a common but troublesome complication in patients who undergo laparoscopic bariatric surgery (LBS). Whether sugammadex use is... (Randomized Controlled Trial)
Randomized Controlled Trial
Use of sugammadex is associated with reduced incidence and severity of postoperative nausea and vomiting in adult patients with obesity undergoing laparoscopic bariatric surgery: a post-hoc analysis.
BACKGROUND
Postoperative nausea and vomiting (PONV) is a common but troublesome complication in patients who undergo laparoscopic bariatric surgery (LBS). Whether sugammadex use is related to the persistent decrease in the occurrence of PONV during postoperative inpatient hospitalization, which is critical for the rehabilitation of patients after LBS, remains unknown.
METHODS
The study was based on a randomized controlled trial conducted in an accredited bariatric centre. A total of 205 patients who underwent LBS were included in the analysis. Univariate analysis and multivariable logistic regression model were used to identify the significant variables related to PONV. Then propensity score matching and inverse probability of treatment weighting (IPTW) were employed to compare outcomes between the sugammadex and neostigmine groups. The primary outcome was the incidence of PONV within 48 h after LBS. The secondary endpoints included the severity of PONV, time to first flatus, need for rescue antiemetic therapy, and water intake.
RESULTS
The incidence of PONV was 43.4% (89/205) within the first 48 h after LBS. In multivariable analysis, sugammadex use (OR 0.03, 95% CI 0.01-0.09, P < 0.001) was an independent protective factor of PONV. After IPTW adjustment, sugammadex use was associated with lower incidence of PONV (OR 0.54, 95% CI 0.48-0.61, P < 0.001), postoperative nausea (PON) (OR 0.77, 95% CI 0.67-0.88, P < 0.001), and postoperative vomiting (POV) (OR 0.60, 95% CI 0.53-0.68, P < 0.001) within postoperative 48 h. The severity of PON as well as the incidence and severity of POV within the first 24 h were also lower in the sugammadex group (all P < 0.05). Reduced need for rescue antiemetic therapy within the first 24 h, increased water intake for both periods, and earlier first passage of flatus were observed in the sugammadex group (all P < 0.05).
CONCLUSIONS
Compared with neostigmine, sugammadex can reduce the incidence and severity of PONV, increase postoperative water intake, and shorten the time to first flatus in bariatric patients during postoperative inpatient hospitalization, which may play a pivotal role in enhanced recovery.
TRIAL REGISTRATION
Chinese Clinical Trial Registry (ChiCTR2100052418, http://www.chictr.org.cn/showprojen.aspx?proj=134893 , date of registration: October 25, 2021).
Topics: Adult; Humans; Antiemetics; Bariatric Surgery; Flatulence; Incidence; Laparoscopy; Neostigmine; Obesity; Postoperative Nausea and Vomiting; Sugammadex
PubMed: 37189069
DOI: 10.1186/s12871-023-02123-y -
The Journal of Clinical Psychiatry Jun 2020Ondansetron is a 5-HT₃ receptor antagonist that has been approved for the prevention of nausea and vomiting associated with cancer chemotherapy, radiotherapy, and... (Review)
Review
Ondansetron is a 5-HT₃ receptor antagonist that has been approved for the prevention of nausea and vomiting associated with cancer chemotherapy, radiotherapy, and surgery. Ondansetron has also been studied in the treatment of many neuropsychiatric and medical conditions. The drug is commonly used off-label to treat nausea and vomiting of pregnancy (NVP) and hyperemesis gravidarum (HG). Ondansetron crosses the placental barrier, and concerns have been expressed that using ondansetron for NVP/HG during the first trimester of pregnancy may increase the risk of major congenital malformations (MCMs) in the offspring. In this context, findings from a meta-analysis of 6 cohort and 2 case-control studies, read along with the results of subsequently published cohort (n = 3) and case-control (n = 1) studies, suggest that a signal does exist to associate early gestational exposure to ondansetron with an increased risk of heart defects and orofacial defects. Arguments both for and against confounding by indication have been proposed to explain these findings. Nevertheless, even if ondansetron is causally implicated in MCM risk, the absolute increase in risk, such as for orofacial clefts (by 0.03%) and ventricular septal defect (by 0.3%), is small. These small risks should be balanced against the risks associated with inadequately treated NVP/HG, and decision-making must be shared between clinician and patient. Repeated fetal scanning during the second trimester can help in the early detection of malformations, if present.
Topics: Abnormalities, Drug-Induced; Administration, Intravenous; Administration, Oral; Antiemetics; Female; Humans; Morning Sickness; Ondansetron; Pregnancy; Pregnancy Trimester, First; Risk Factors
PubMed: 32526103
DOI: 10.4088/JCP.20f13472 -
The Oncologist Jun 2021Guideline-recommended antiemetic prophylaxis improves nausea and vomiting control in most patients undergoing chemotherapy. Multinational Association of Supportive Care...
BACKGROUND
Guideline-recommended antiemetic prophylaxis improves nausea and vomiting control in most patients undergoing chemotherapy. Multinational Association of Supportive Care in Cancer/European Society for Medical Oncology (MASCC/ESMO) antiemetic guidelines recommend prophylaxis with a neurokinin-1 receptor antagonist (NK RA), a 5-hydroxytryptamine-3 receptor antagonist (5-HT RA), and dexamethasone for patients receiving highly emetogenic chemotherapy (HEC), including anthracycline-cyclophosphamide (AC)- and carboplatin (considered moderately emetogenic chemotherapy)-based chemotherapy. Here, we analyze the use of NK RA-5-HT RA-dexamethasone for antiemetic prophylaxis associated with HEC and carboplatin.
METHODS
The data source was the Global Oncology Monitor (Ipsos Healthcare). Geographically representative physicians from France, Germany, Italy, Spain, and the U.K. were screened for treatment involvement and number of patients treated per month. Patients' data from January to December 2018 were collected from medical charts and extrapolated on the basis of the total number of physicians who prescribe chemotherapy. The emetic risk of chemotherapy was classified per MASCC/ESMO guidelines.
RESULTS
Data from 45,324 chemotherapy-treated patients were collected, representing a total extrapolated prevalence of 1,394,848 chemotherapy treatments included in the analysis. NK RAs were used in 45%, 42%, and 19% of patients receiving cisplatin-, AC-, and carboplatin-based chemotherapy, respectively; 18%, 24%, and 7% received the guideline-recommended NK RA-5-HT RA-dexamethasone combination; no antiemetics were prescribed for 12% of the treatments. Often, physicians' perception of the emetic risk of chemotherapy did not follow MASCC/ESMO guideline classification.
CONCLUSION
Low adherence to antiemetic guidelines was revealed in clinical practice in five European countries, with 15% of all HEC-/carboplatin-based treatments receiving guideline-recommended NK RA-5-HT RA-dexamethasone prophylaxis and 12% of them receiving no antiemetics. New strategies for improving guideline adherence are urgently needed.
IMPLICATIONS FOR PRACTICE
Despite recent advances in antiemetic therapy, a substantial proportion of patients experience nausea and vomiting associated with chemotherapy in daily clinical practice. Antiemetic guidelines aim at prevention of chemotherapy-induced nausea and vomiting (CINV), and guideline-consistent antiemetic therapy can effectively prevent vomiting and, to a lesser extent, nausea in most patients with cancer. This study reports low adherence to antiemetic guidelines in the highly emetogenic chemotherapy setting in daily clinical practice across five European countries. Opportunity exists to increase adherence to antiemetic guideline recommendations. Implementation of strategies to facilitate guideline adherence can potentially improve CINV control.
Topics: Antibiotics, Antineoplastic; Antiemetics; Antineoplastic Agents; Europe; France; Germany; Guideline Adherence; Humans; Italy; Nausea; Spain; Vomiting
PubMed: 33555084
DOI: 10.1002/onco.13716 -
The efficacy of aprepitant for the prevention of postoperative nausea and vomiting: A meta-analysis.Medicine Jul 2023Postoperative nausea and vomiting (PONV) is one of the common adverse reactions after surgery. Recent randomized controlled trials (RCTs) investigating antiemetic drugs... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Postoperative nausea and vomiting (PONV) is one of the common adverse reactions after surgery. Recent randomized controlled trials (RCTs) investigating antiemetic drugs suggest that aprepitant has the strongest antiemetic effect of any single drug. This meta-analysis aimed to explore the efficacy of aprepitant for preventing PONV based on the existing literature.
METHODS
To identify RCTs investigating the use of aprepitant for PONV prevention, we searched PubMed, Embase, and Cochrane Library databases for articles published prior to March 20, 2022. Seventeen RCTs were identified, with 3299 patients, meeting the inclusion criteria. PONV incidence, complete response, 80 mg aprepitant combined with dexamethasone and ondansetron, vomiting, nausea, and analgesic dose-response were the main outcomes measured.
RESULTS
Compared with the control group, PONV incidence was significantly reduced among those receiving aprepitant (odds ratio [OR]: 0.34; 95% confidence interval [CI]: 0.26, 0.44; P < .0001), with a more complete response (OR: 1.35; 95% CI: 1.14, 1.59; P = .0004). Supplementation of 80 mg aprepitant in combination with dexamethasone and ondansetron substantially improved the effects of PONV (OR: 0.36; 95% CI: 0.16, 0.82; P = .01). Further, administration of 80 mg aprepitant was better at preventing vomiting than nausea (OR: 8.6; 95% CI: 3.84, 19. 29; P < .00001). No statistically significant difference between the dose-response of analgesics was identified (mean difference: -1.09; 95% CI: -6.48, 4.30; P = .69). The risk of bias was assessed independently by paired evaluators.
CONCLUSION
Aprepitant effectively reduces the incidence of PONV; however, the effects of postoperative analgesia require further exploration.
Topics: Humans; Aprepitant; Postoperative Nausea and Vomiting; Ondansetron; Morpholines; Antiemetics; Vomiting; Dexamethasone
PubMed: 37478247
DOI: 10.1097/MD.0000000000034385 -
Annals of Palliative Medicine May 2023Cancer patients often experience symptoms such as anorexia, anxiety and insomnia, which can impact their quality of life. Randomized placebo-controlled trials support...
BACKGROUND
Cancer patients often experience symptoms such as anorexia, anxiety and insomnia, which can impact their quality of life. Randomized placebo-controlled trials support prophylactic use of olanzapine for the prevention of nausea and vomiting due to moderate and high-emetic risk chemotherapy. In the setting of palliative care, olanzapine is increasingly utilized as an off-label treatment of symptoms including anorexia-cachexia, anxiety, and insomnia. The following case reports will highlight the potential benefits and risks of off-label olanzapine use for symptom management in cancer patients.
CASE DESCRIPTION
Patient 1 is a female in her 70s with stage IV infiltrating ductal carcinoma of the right breast was having trouble tolerating treatment with letrozole, palbociclib, and denosumab due to uncontrolled nausea resulting in weight loss. Her nausea was refractory to multiple anti-emetics. Low dose olanzapine (2.5 mg) prevented nausea and allowed her to tolerate treatment. Patient 2 is a male in his 50s with renal cell carcinoma, who was receiving treatment with cabozantinib, presented with uncontrolled pain improved with opioid rotation from oxycodone to morphine. He was also experiencing uncontrolled anxiety despite treatment with alprazolam. Alprazolam was weaned and replaced with olanzapine resulting in improvement of his symptoms. Patient 3 is a male in his 60s with pancreatic adenocarcinoma who presented with muscle weakness and fatigue resulting in discontinuation of gemcitabine plus cisplatin. He also had symptoms of depression, poor appetite, and sleep problems. He was prescribed short course of dexamethasone 4 mg by mouth twice daily and olanzapine 5 mg by mouth nightly to improve symptoms. One week after, he presented with confusion and workup revealed hyperammonia which was treated with lactulose, which led to the return of baseline mentation.
CONCLUSIONS
Olanzapine antagonizes multiple receptors and has potential to treat a host of symptoms including nausea, anorexia, anxiety, and insomnia, but healthcare providers should be mindful of potential risks and unclear benefits for off-label indications. More research and funding are needed evaluating off-label use of olanzapine for palliation of symptoms in cancer patients who are often frail and susceptible to adverse events.
Topics: Female; Humans; Male; Adenocarcinoma; Alprazolam; Anorexia; Antiemetics; Cisplatin; Nausea; Off-Label Use; Olanzapine; Palliative Care; Pancreatic Neoplasms; Quality of Life; Risk Assessment; Sleep Initiation and Maintenance Disorders; Vomiting; Aged; Middle Aged
PubMed: 37038067
DOI: 10.21037/apm-22-1167 -
BMC Anesthesiology Mar 2024Postoperative nausea and vomiting (PONV) is one of the most common adverse events following orthognathic surgery. It's a distressing feeling for patients and continues... (Review)
Review
INTRODUCTION
Postoperative nausea and vomiting (PONV) is one of the most common adverse events following orthognathic surgery. It's a distressing feeling for patients and continues to be the cause of postoperative complications such as bleeding, delayed healing, and wound infection. This scoping review aims to identify effective PONV prophylaxis strategies during orthognathic surgery that have emerged in the past 15 years.
METHODS
We searched Pubmed, Cochrane Controlled Register of Trials, and Embase from 2008 to May 2023. Studies meeting the following criteria were eligible for inclusion: (1) recruited patients undergo any orthognathic surgery; (2) evaluated any pharmacologic or non-pharmacologic method to prevent PONV. Studies meeting the following criteria were excluded: (1) case series, review papers, or retrospective studies; (2) did not report our prespecified outcomes.
RESULTS
Twenty-one studies were included in this review. Pharmacological methods for PONV prevention include ondansetron and dexamethasone (3 studies), peripheral nerve block technique (4 studies), dexmedetomidine (1 study), pregabalin (2 studies), nefopam (2 studies), remifentanil (1 study), propofol (2 studies), and penehyclidine (1 study). Non-pharmacologic methods include capsicum plaster (1 study), throat packs (2 studies) and gastric aspiration (2 studies).
CONCLUSIONS
Based on current evidence, we conclude that prophylactic antiemetics like dexamethasone, ondansetron, and penehyclidine are the first defense against PONV. Multimodal analgesia with nerve block techniques and non-opioid analgesics should be considered due to their notable opioid-sparing and PONV preventive effect. For the non-pharmacological methods, throat packs are not recommended for routine use because of their poor effect and serious complications. More prospective RCTs are required to confirm whether gastric aspiration can prevent PONV effectively for patients undergoing orthognathic surgery.
Topics: Humans; Postoperative Nausea and Vomiting; Ondansetron; Orthognathic Surgery; Prospective Studies; Retrospective Studies; Antiemetics; Dexamethasone
PubMed: 38539078
DOI: 10.1186/s12871-024-02510-z -
Advances in Therapy May 2023Chemotherapy-induced nausea and vomiting (CINV) is often ranked by patients as one of the most distressing and feared consequences of chemotherapy. The novel... (Review)
Review
Chemotherapy-induced nausea and vomiting (CINV) is often ranked by patients as one of the most distressing and feared consequences of chemotherapy. The novel neurokinin-1 (NK) receptor antagonist fosnetupitant, a phosphorylated prodrug formulation of netupitant, was approved in Japan in 2022. Fosnetupitant is one of the standard treatments for the prevention of CINV in patients who are receiving highly (any treatment where CINV occurs in more than 90% of patients) or moderately (where CINV occurs in 30-90% of patients) emetogenic chemotherapies. The aim of this commentary is to describe the mechanism of action, tolerability, and antiemetic efficacy of single-agent fosnetupitant in the prevention of CINV, and to discuss its clinical application, in order to aid optimal use.
Topics: Humans; Vomiting; Nausea; Antiemetics; Quinuclidines; Antineoplastic Agents
PubMed: 36884027
DOI: 10.1007/s12325-023-02474-5 -
Obesity Surgery Mar 2022Laparoscopic sleeve gastrectomy (LSG) has become a single-step operation for the management of severe obesity. A statistically significant number of participants who... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Laparoscopic sleeve gastrectomy (LSG) has become a single-step operation for the management of severe obesity. A statistically significant number of participants who undergo this procedure experience nausea, vomiting, and reflux symptoms early after the operation. The objectives of this study were to measure the positive or negative effect of gastropexy on reducing distressing postoperative LSG-related gastrointestinal symptoms.
PATIENTS AND METHODS
This was a comparative randomized study conducted from January 2018 to January 2021. The study was carried out in the general surgery department at Menoufia University Hospital, Menoufia Faculty of Medicine in Egypt. Two hundred participants were included randomly during this trial. The participants were divided into two groups, with 100 patients in each group. Patients in group A underwent gastropexy, and patients in group B underwent LSG without gastropexy.
RESULTS
There was no significant difference between the groups in age or sex (p > 0.05). There was no significant difference in the length of hospital stay (p > 0.05). There was a significant difference between the two groups regarding nausea, vomiting, reflux symptoms, and the amount and frequency of antiemetics used (p < 0.001). There was also a significant difference in hospital readmissions (p < 0.05) and in clinic visits during the postoperative period.
CONCLUSIONS
Patients who underwent gastropexy showed a significant reduction in antiemetic consumption and a significantly lower incidence of postoperative nausea, vomiting, gastroesophageal reflux disease symptoms and gastric torsion than those who did not undergo gastropexy.
Topics: Antiemetics; Gastrectomy; Gastroesophageal Reflux; Gastropexy; Humans; Laparoscopy; Obesity, Morbid; Postoperative Complications; Postoperative Nausea and Vomiting; Retrospective Studies; Treatment Outcome
PubMed: 34870791
DOI: 10.1007/s11695-021-05806-y