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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 -
BMC Surgery Nov 2023Antiemetic and analgesic oral premedications are frequently prescribed preoperatively to enhance recovery after laparoscopic sleeve gastrectomy. However, it is unknown... (Observational Study)
Observational Study
BACKGROUND
Antiemetic and analgesic oral premedications are frequently prescribed preoperatively to enhance recovery after laparoscopic sleeve gastrectomy. However, it is unknown whether these medications transit beyond the stomach or if they remain in the sleeve resection specimen, thereby negating their pharmacological effects.
METHODS
A retrospective cohort study was performed on patients undergoing laparoscopic sleeve gastrectomy and receiving oral premedication (slow-release tapentadol and netupitant/palonosetron) as part of enhanced recovery after bariatric surgery program. Patients were stratified into the Transit group (premedication absent in the resection specimen) and Failure-to-Transit group (premedication present in the resection specimen). Age, sex, body mass index, and presence of diabetes were compared amongst the groups. The premedication lead time (time between premedications' administration and gastric specimen resection), and the premedication presence or absence in the specimen was evaluated.
RESULTS
One hundred consecutive patients were included in the analysis. Ninety-nine patients (99%) were morbidly obese, and 17 patients (17%) had Type 2 diabetes mellitus. One hundred patients (100%) received tapentadol and 89 patients (89%) received netupitant/palonosetron. One or more tablets were discovered in the resected specimens of 38 patients (38%). No statistically significant differences were observed between the groups regarding age, sex, diabetes, or body mass index. The median (Q1‒Q3) premedication lead time was 80 min (57.8‒140.0) in the Failure-to-Transit group and 119.5 min (85.0‒171.3) in the Transit group; P = 0.006. The lead time required to expect complete absorption in 80% of patients was 232 min (95%CI:180‒310).
CONCLUSIONS
Preoperative oral analgesia and antiemetics did not transit beyond the stomach in 38% of patients undergoing laparoscopic sleeve gastrectomy. When given orally in combination, tapentadol and netupitant/palonosetron should be administered at least 4 h before surgery to ensure transition beyond the stomach. Future enhanced recovery after bariatric surgery guidelines may benefit from the standardization of premedication lead times to facilitate increased absorption.
TRIAL REGISTRATION
Australian and New Zealand Clinical Trials Registry; number ACTRN12623000187640; retrospective registered on 22/02/2023.
Topics: Humans; Australia; Diabetes Mellitus, Type 2; Gastrectomy; Laparoscopy; Obesity, Morbid; Palonosetron; Retrospective Studies; Stomach; Tapentadol; Treatment Outcome; Male; Female
PubMed: 37924061
DOI: 10.1186/s12893-023-02246-6 -
Medicine Oct 2023To investigate the efficacy and safety of dexamethasone + palonosetron in the prevention of post-embolization syndrome after drug-eluting beads transcatheter...
To investigate the efficacy and safety of dexamethasone + palonosetron in the prevention of post-embolization syndrome after drug-eluting beads transcatheter arterial chemoembolization (D-TACE). The data of 278 patients who received D-TACE from January 2018 to December 2021 were collected and divided into 2 groups: D-TACE group (N = 145) and D-TACE + dexamethasone + palonosetron group (N = 133). The incidence of post-embolization syndrome and infection after D-TACE was assessed in both groups. Incidence of abdominal pain: D-TACE group versus D-TACE + dexamethasone + palonosetron group, 56.6% versus 40.6%, P = .008; incidence of fever: D-TACE group versus D-TACE + dexamethasone + palonosetron group, 40.0% versus 14.3%, P = .000; incidence of nausea: D-TACE group versus D-TACE + dexamethasone + palonosetron group, 61.4% versus 39.8%, P = .001; incidence of vomiting: D-TACE group versus D-TACE + dexamethasone + palonosetron group, 48.3% versus 21.1%, P = .000; incidence of infection: D-TACE group versus D-TACE + dexamethasone + palonosetron group, 1.4% versus 1.5%, P = .931. The combined use of dexamethasone and palonosetron before D-TACE can effectively reduce the incidence of post-embolization syndrome and reduce the degree of side effects, but it will not increase the risk of infection.
Topics: Humans; Palonosetron; Antiemetics; Retrospective Studies; Dexamethasone; Carcinoma, Hepatocellular; Liver Neoplasms; Chemoembolization, Therapeutic; Vomiting
PubMed: 37800841
DOI: 10.1097/MD.0000000000035433 -
Advances in Therapy Nov 2023Fosnetupitant is a novel neurokinin 1 receptor antagonist (NKRA) with favorable antiemetic efficacy in patients receiving emetogenic chemotherapy. This study assessed... (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION
Fosnetupitant is a novel neurokinin 1 receptor antagonist (NKRA) with favorable antiemetic efficacy in patients receiving emetogenic chemotherapy. This study assessed the efficacy of fosnetupitant in combination with palonosetron and dexamethasone and identified risk factors for chemotherapy-induced nausea and vomiting (CINV) for up to 168 h after treatment using pooled data from Japanese studies.
METHODS
A pooled analysis of randomized phase II and phase III studies was performed to compare the efficacy of fosnetupitant and fosaprepitant in patients receiving cisplatin-based chemotherapy. The complete response (CR; no vomiting and no rescue medication) rate, CINV risk factors in various phases (0-120, 0-168, and 120-168 h), and impact of the number of risk factors on the time to treatment failure (TTF) were examined in the overall and NKRA evaluable populations.
RESULTS
In the combined cohort of NKRA evaluable patients (n = 980), the CR rate at 0-168 h was significantly better in the fosnetupitant 235 mg group than in the fosaprepitant group (rate difference = 6.8%, 95% confidence interval = 1.0-12.7, p = 0.022). In the overall (n = 1368) and NKRA evaluable populations, the CINV risk factor at 120-168 h was treatment failure in the first 120 h. TTF deteriorated as the number of identified CINV risk factors increased.
CONCLUSION
This analysis revealed that fosnetupitant could have long-acting antiemetic potency (> 120 h) and indicated the importance of antiemetic therapy at 0-120 h for CINV up to 168 h after chemotherapy.
Topics: Humans; Antiemetics; Antineoplastic Agents; Cisplatin; Dexamethasone; Nausea; Quinuclidines; Risk Factors; Vomiting
PubMed: 37715851
DOI: 10.1007/s12325-023-02648-1 -
Advanced Biomedical Research 2023In order to improve the complete recovery of nausea and vomiting, we conducted a study with the aim of preventing acute and delayed nausea and vomiting in children...
BACKGROUND
In order to improve the complete recovery of nausea and vomiting, we conducted a study with the aim of preventing acute and delayed nausea and vomiting in children undergoing moderate emetogenic chemotherapy.
MATERIALS AND METHODS
A clinical trial study was done on 130 children received chemotherapy. Patients received olanzapine and placebo. All groups received granisetron along with dexamethasone (DEX). The severity of chemotherapy-induced nausea and vomiting (CINV) induced by chemotherapy was compared in two groups.
RESULTS
The severity of nausea on the first, second, third, and fourth days was not significantly different ( > .05) in two groups. The number of patients without vomiting was significantly different during the first 24 hours after chemotherapy between patients in the two groups (82.3% vs 64.5%; = .016).
CONCLUSION
This study showed that olanzapine, which acts as an inhibitor of neurotransmitters, had a favorable efficacy in controlling acute and delayed CINV. More studies with large sample size are needed to compare the effect of olanzapine with other agents including aprepitant and palonosetron in the prevention of CINV.
PubMed: 37564446
DOI: 10.4103/abr.abr_356_22 -
Cancer Medicine Aug 2023Non-inferiority of NEPA (fixed combination of NK receptor antagonist (RA), netupitant, and 5-HT RA, palonosetron) versus an aprepitant regimen was previously shown in a... (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION
Non-inferiority of NEPA (fixed combination of NK receptor antagonist (RA), netupitant, and 5-HT RA, palonosetron) versus an aprepitant regimen was previously shown in a pragmatic study in patients receiving anthracycline cyclophosphamide (AC) and non-AC moderately emetogenic chemotherapy (MEC). In the MEC group a numerically higher complete response (CR: no emesis, no rescue) rate was seen for NEPA during the overall 0-120 h phase (NEPA 76.1% vs. 63.1% aprepitant). As NEPA exhibits long-lasting efficacy, this study evaluated a prolonged period up to 144 h, beyond the traditional 120 h post-chemotherapy. In this post-hoc analysis we explore the comparative efficacy of NEPA versus the aprepitant regimen in the MEC group up to 144 h, while also assessing the impact of risk factors on CINV prevention.
METHODS
This was a pragmatic, multicenter, randomized, prospective study. Oral NEPA was administered as a single dose on day 1, while aprepitant was given on days 1-3 + ondansetron on day 1; all patients were to receive dexamethasone on days 1-4. Patients were chemotherapy-naïve and receiving MEC, with a subset evaluation of those with a risk factor for developing CINV (i.e., female, male <60 years, male ≥60 years who received carboplatin, or male ≥60 years with anxiety). CR rates were compared during the extended overall (0-144 h) phase.
RESULTS
The MEC group included 211 patients; of these 181 were in the risk factor subset. Significantly higher CR rates were seen for NEPA than aprepitant during the extended overall phase for the total MEC group (NEPA 77.1%, aprepitant 57.8%, p = 0.003) and also in the subset of patients with CINV risk factors (NEPA 73.9%, aprepitant 56.2%, p = 0.012).
CONCLUSION
A single dose of NEPA, administered on day 1 only, was more effective than a 3-day aprepitant regimen in preventing CINV for an extended duration in patients receiving MEC and in those with emetic risk factors.
Topics: Humans; Male; Female; Aprepitant; Antiemetics; Vomiting; Prospective Studies; Isoquinolines; Quinuclidines; Drug Combinations; Nausea; Cyclophosphamide; Anthracyclines; Antineoplastic Agents; Dexamethasone
PubMed: 37537943
DOI: 10.1002/cam4.6121 -
Farmacia Hospitalaria : Organo Oficial... 2023Latest MASCC/ESMO guidelines of the recommendations for the prophylaxis of acute and delayed emesis induced by moderately emetogenic chemotherapy was published in 2016... (Observational Study)
Observational Study
OBJECTIVE
Latest MASCC/ESMO guidelines of the recommendations for the prophylaxis of acute and delayed emesis induced by moderately emetogenic chemotherapy was published in 2016 incorporating anthracycline schemes as highly emetogenic chemotherapy (HEC), proposing triple antiemetic therapy to control nausea and vomiting. Likewise, they recommend triple therapy for carboplatin. The objectives of this study were to analyze the degree of concordance between guidelines and antiemetic prophylaxis used in the Chemotherapy Outpatient Unit in patients undergoing treatment with HEC and carboplatin, to evaluate its effectiveness and to determine the savings due to the use of netupitant/palonosetron (NEPA) oral (or) with intravenous (iv) dexamethasone (NEPAd) compared to iv Fosaprepitant with ondansetron and dexamethasone (FOD iv).
METHODS
Prospective observational study recording demographic variables, chemotherapy protocol, tumor location, patient emetogenic risk, antiemetic regimen prescribed, concordance with the MASCC/ESMO guideline, and effectiveness, evaluated by MASCC survey, use of rescue medication and visits to the Emergency Department or hospitalization due to emesis. A cost minimization pharmacoeconomic study was carried out.
RESULTS
61 patients were included; 70% women; median age 60.5. Platinum schemes were more frequent in period 1, being 87.5% compared to 67.6% in period 2. Anthracycline schemes were 21.6% and 10% respectively in each period. A 21.1% of the antiemetic regimens did not coincide with the MASCC/ESMO recommendations, being entirely in period 1. The score of the effectiveness questionnaires was total protection in 90.9% in acute nausea, from 100% in acute vomiting and delayed nausea, and 72.7% in delayed vomiting. The frequency of use of rescue medication was 18.7% in period 1 and was not necessary in period 2. No visits to the emergency room or admissions were detected in any of the periods.
CONCLUSIONS
Use of NEPAd led to a 28% reduction in costs with respect to the use of FOD. A high level of concordance was obtained in both periods between the latest published guideline and healthcare practice in our field. Surveys carried out on patients seem to suggest that both antiemetic therapies have similar effectiveness in clinical practice. The inclusion of NEPAd has led to a reduction in costs, positioning itself as an efficient option.
Topics: Humans; Female; Middle Aged; Male; Antiemetics; Carboplatin; Anthracyclines; Nausea; Vomiting; Antibiotics, Antineoplastic; Dexamethasone; Antineoplastic Agents
PubMed: 37500396
DOI: 10.1016/j.farma.2023.06.007 -
British Journal of Anaesthesia Oct 2023Postoperative nausea and vomiting (PONV) is a major problem after surgery. Even with double prophylactic therapy including dexamethasone and a 5-hydroxytryptamine-3... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Postoperative nausea and vomiting (PONV) is a major problem after surgery. Even with double prophylactic therapy including dexamethasone and a 5-hydroxytryptamine-3 receptor antagonist, the incidence is still high in many at-risk patients. Fosaprepitant, a neurokinin-1 receptor antagonist, is an effective antiemetic, but its efficacy and safety in combination antiemetic therapy for preventing PONV remain unclear.
METHODS
In this randomised, controlled, double-blind trial, 1154 participants at high risk of PONV and undergoing laparoscopic gastrointestinal surgery were randomly assigned to either a fosaprepitant group (n=577) receiving fosaprepitant 150 mg i.v. dissolved in 0.9% saline 150 ml, or a placebo group (n=577) receiving 0.9% saline 150 ml before anaesthesia induction. Dexamethasone 5 mg i.v. and palonosetron 0.075 i.v. mg were each administered in both groups. The primary outcome was the incidence of PONV (defined as nausea, retching, or vomiting) during the first 24 postoperative hours.
RESULTS
The incidence of PONV during the first 24 postoperative hours was lower in the fosaprepitant group (32.4% vs 48.7%; adjusted risk difference -16.9% [95% confidence interval: -22.4 to -11.4%]; adjusted risk ratio 0.65 [95% CI: 0.57 to 0.76]; P<0.001). There were no differences in severe adverse events between groups, but the incidence of intraoperative hypotension was higher (38.0% vs 31.7%, P=0.026) and intraoperative hypertension (40.6% vs 49.2%, P=0.003) was lower in the fosaprepitant group.
CONCLUSIONS
Fosaprepitant added to dexamethasone and palonosetron reduced the incidence of PONV in patients at high risk of PONV undergoing laparoscopic gastrointestinal surgery. Notably, it increased the incidence of intraoperative hypotension.
CLINICAL TRIAL REGISTRATION
NCT04853147.
Topics: Humans; Postoperative Nausea and Vomiting; Antiemetics; Palonosetron; Digestive System Surgical Procedures; Saline Solution; Laparoscopy; Dexamethasone; Double-Blind Method
PubMed: 37423834
DOI: 10.1016/j.bja.2023.06.029 -
BMC Cancer Jul 2023Even though chemotherapy-induced nausea and vomiting (CINV) can be well controlled in the acute phase, the incidence of delayed CINV remains high. In this study, we... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Even though chemotherapy-induced nausea and vomiting (CINV) can be well controlled in the acute phase, the incidence of delayed CINV remains high. In this study, we intend to investigate whether prolonged use of NK-1 receptor antagonist (RA) in addition to 5-HT3 RA and dexamethasone (DEX) was more effective in preventing delayed CINV.
METHODS
This randomised, open-label, controlled study was designed to compare the efficacy and safety of fosaprepitant 150 mg given on days 1,3 (prolonged group) versus on day 1 (regular group) in patients receiving highly emetogenic chemotherapy (HEC). All patients also treated with palonosetron on day 1 and DEX on days 1-3. The primary endpoint was the incidence of delayed nausea and vomiting. The second endpoint was AEs. All the above endpoints were defined according to CTCAE 5.0.
RESULTS
Seventy-seven patients were randomly assigned to prolonged group and seventy-nine to regular group. Prolonged group demonstrated superiority in controlling delayed CINV to regular group, with statistically significant lower incidence of nausea (6.17% vs 12.66%, P = 0.0056), and slightly lower incidence of grade 1 vomiting (1.62% vs 3.80%, P = 0.0953) in the delayed phase. In addition, prolonged use of fosaprepitant was safe. No significant difference was found between the two groups regarding constipation, diarrhea, hiccough, fatigue, palpitation and headache in delayed phase.
CONCLUSIONS
Prolonged use of fosaprepitant can effectively and safely prevent delayed CINV in patients receiving HEC.
Topics: Humans; Nausea; Vomiting; Morpholines; Antineoplastic Agents
PubMed: 37393241
DOI: 10.1186/s12885-023-11070-3 -
BMC Pulmonary Medicine Jun 2023Appropriate monitoring and management of chemotherapy-induced nausea and vomiting (CINV) with prophylactic antiemetics is important for cancer patients. This study was...
OBJECTIVE
Appropriate monitoring and management of chemotherapy-induced nausea and vomiting (CINV) with prophylactic antiemetics is important for cancer patients. This study was performed to validate the clinical practice of antiemetic use with carboplatin-based chemotherapy in lung cancer patients in the Hokushin region (Toyama, Ishikawa, Fukui, and Nagano prefectures), Japan.
METHODS
We surveyed retrospective data of newly diagnosed and registered lung cancer patients initially treated with carboplatin-based chemotherapy in 21 principal hospitals in the Hokushin region linked with health insurance claims data between 2016 and 2017.
RESULTS
A total of 1082 lung cancer patients (861 [79.6%] men, 221 [20.4%] women; median age 69.4 years [range, 33-89 years]). All patients received antiemetic therapy, with 613 (56.7%) and 469 patients (43.3%) receiving 5-hydroxytryptamine-3 receptor antagonist/dexamethasone double regimen and 5-hydroxytryptamine-3 receptor antagonist/dexamethasone/neurokinin-1 receptor antagonist triple regimen, respectively. However, the rates of double regimen and use of palonosetron were higher in Toyama and Fukui prefectures. Thirty-nine patients (3.6%) changed from double to triple regimen, while 41 patients (3.8%) changed from triple to double regimen after the second cycle, but six of these returned to triple antiemetics in subsequent cycles.
CONCLUSION
Adherence to antiemetic guidelines in clinical practice was high in Hokushin region. However, rates of double and triple antiemetic regimens differed between the four prefectures. Simultaneous analysis of nationwide registry and insurance data was valuable for evaluating and comparing the differences in the status of antiemesis and management.
Topics: Male; Humans; Female; Aged; Antiemetics; Carboplatin; Retrospective Studies; Receptors, Serotonin, 5-HT3; Dexamethasone; Vomiting; Lung Neoplasms; Antineoplastic Combined Chemotherapy Protocols; Antineoplastic Agents
PubMed: 37365528
DOI: 10.1186/s12890-023-02524-2