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Neuropsychopharmacology Reports Sep 2022Antipsychotics with dopamine (D2) receptor antagonism can be effective for emesis in cancer patients. Extrapyramidal symptoms (EPS) induced by typical antipsychotics can...
BACKGROUND
Antipsychotics with dopamine (D2) receptor antagonism can be effective for emesis in cancer patients. Extrapyramidal symptoms (EPS) induced by typical antipsychotics can be exacerbated by other D2 receptor antagonists. We describe a case of persistent EPS induced by long-term, intermittent administration of low-dose olanzapine along with metoclopramide for emesis.
CASE PRESENTATION
A 59-year-old pancreatic cancer patient underwent chemotherapy for 7 months. He was referred to the psychiatry department because of restlessness and insomnia. Although he did not have obvious depressive symptoms, he was anxious about the cancer treatment. For chemotherapy-induced nausea, he had been prescribed 5 mg of olanzapine intermittently for 7 months. He had last used the drug 9 days before presenting it to us. Additionally, he received metoclopramide and palonosetron as antiemetics. We considered akathisia and cancer-related anxiety/agitation as possible causes of restlessness and insomnia, and prescribed clonazepam. However, his symptoms worsened, resulting in hospitalization. We reconsidered his symptoms as cancer-related anxiety/agitation and prescribed quetiapine. Although it was effective, he had tremors and was assessed by a neurologist. Considering the clinical manifestations of rigidity, postural reflex disorder, and a mask-like face, we suspected drug-induced parkinsonism and replaced quetiapine with biperiden on the next day, leading to his discharge after 2 weeks. He did not have symptom recurrence even after discontinuation of biperiden.
CONCLUSIONS
Long-term, intermittent administration of low-dose antipsychotics with other antiemetics having D2 receptor antagonism can cause prolonged EPS. Especially in cancer patients, who often require polypharmacy, clinicians should consider exacerbated adverse effects due to drug interactions.
Topics: Antiemetics; Antineoplastic Agents; Antipsychotic Agents; Biperiden; Clonazepam; Dopamine; Humans; Male; Metoclopramide; Middle Aged; Olanzapine; Palonosetron; Psychomotor Agitation; Quetiapine Fumarate; Sleep Initiation and Maintenance Disorders; Vomiting
PubMed: 35716124
DOI: 10.1002/npr2.12277 -
Breast Care (Basel, Switzerland) Apr 2022In a prospective non-interventional study involving 2,173 patients, we showed that use of the oral fixed combination of netupitant 300 mg and palonosetron 0.5 mg (NEPA)...
Quality of Life Effects of an Oral Fixed Combination of Netupitant and Palonosetron in Chemotherapy-Induced Nausea and Vomiting Prevention: Real-World Evidence in Patients with Breast Cancer Receiving Anthracycline-Cyclophosphamide-Based Chemotherapy.
INTRODUCTION
In a prospective non-interventional study involving 2,173 patients, we showed that use of the oral fixed combination of netupitant 300 mg and palonosetron 0.5 mg (NEPA) for prevention of chemotherapy (Ctx)-induced nausea and vomiting has beneficial effects on the quality of life (QoL) of patients with various types of cancers receiving highly or moderately emetogenic Ctx. Here, we report on the effects on QoL, effectiveness, and tolerability of NEPA in patients with breast cancer exposed to anthracycline-cyclophosphamide (AC)-based Ctx.
METHODS
This is a post hoc subanalysis of a prospective non-interventional study in 1,197 patients with breast cancer receiving up to 3 cycles of doxorubicin or epirubicin plus cyclophosphamide and NEPA. NEPA administration was per the summary of product characteristics.
RESULTS
In cycle 1 of Ctx, a large proportion of patients (84%) reported "no impact on daily life" (NIDL) due to vomiting; 53% of patients reported NIDL due to nausea. The complete response rate was 86/88/81% in the acute/delayed/overall phase in cycle 1, and NEPA was well tolerated throughout the study.
CONCLUSION
The real-world beneficial effects of NEPA prophylaxis on QoL were confirmed for patients with breast cancer receiving AC. NEPA was effective with a good safety profile in this patient population in clinical practice.
PubMed: 35702496
DOI: 10.1159/000514891 -
Frontiers in Pharmacology 2022To test the hypothesis that the single use of fosaprepitant is not inferior to the use of palonosetron as antiemetic prophylaxis in the first 48 h after surgery in...
Comparative Study Between Fosaprepitant and Palonosetron in the Prophylaxis of Postoperative Nausea and Vomiting in Women Undergoing Laparoscopic Cholecystectomy: Prospective, Randomized and Double-Blind Study.
To test the hypothesis that the single use of fosaprepitant is not inferior to the use of palonosetron as antiemetic prophylaxis in the first 48 h after surgery in women undergoing laparoscopic cholecystectomy. Eighty-eight nonsmoking women (American Society of Anesthesiologists physical status I or II) aged between 18 and 60 years who underwent laparoscopic cholecystectomy received 150 mg of fosaprepitant or 75 μg of palonosetron, administered intravenously after the induction of general anesthesia. In the fosaprepitant group and in the palonosetron group, 13.6 and 18.2% of the patients, respectively, vomited in the first 48 h after surgery ( = 0.560). There were no differences between groups in the total frequency and intensity of nausea, number of complete responders, need for rescue medication, time required for the first rescue medication dose or number of adverse events. The administration of a single dose of fosaprepitant after the induction of anesthesia was as effective as the administration of a single dose of palonosetron for the prophylaxis of vomiting in the first 48 h after surgery in women undergoing laparoscopic cholecystectomy.
PubMed: 35645797
DOI: 10.3389/fphar.2022.915347 -
Journal of Pharmaceutical Health Care... Jun 2022Olanzapine has been shown to have an additive effect on the three-drug antiemetic therapy consisting of aprepitant, palonosetron, and dexamethasone, in a highly...
BACKGROUND
Olanzapine has been shown to have an additive effect on the three-drug antiemetic therapy consisting of aprepitant, palonosetron, and dexamethasone, in a highly emetogenic cisplatin-containing chemotherapy. Although olanzapine may be more economical than aprepitant or palonosetron, an adequate cost-efficacy analysis has not been conducted.
METHODS
We conducted a cost-utility analysis to evaluate the cost-effectiveness of olanzapine use in four-drug antiemetic therapy among Japanese patients. We simulated model patients treated with highly emetogenic cisplatin-containing chemotherapy and developed a decision-analytical model of patients receiving triple antiemetic therapy with or without olanzapine in an inpatient setting. The cost and probabilities of each treatment were calculated from the perspective of the Japanese healthcare payer. The probabilities, utility value, and other costs were obtained from published sources. One-way and probabilistic sensitivity analyses were conducted to examine the influence of each parameter on the model and the robustness of a base-case analysis. Threshold analysis was conducted to determine the cost of olanzapine that would make the incremental cost-effectiveness ratio (ICER) equivalent to the threshold ICER). The threshold incremental cost-effectiveness ratio was set at 5 million Japanese Yen (JPY) per quality-adjusted life-year (QALY) gained.
RESULTS
The cost was 10,238 JPY in the olanzapine regimen and 9719 JPY in the non-olanzapine regimen. The QALY gained were 0.01065 QALYs and 0.01029 QALYs in the olanzapine and non-olanzapine regimen, respectively. The incremental cost of the olanzapine regimen relative to the non-olanzapine regimen was 519 JPY, and the incremental QALYs were 0.00036 QALY, resulting in an ICER of 1,428,675 JPY per QALY gained. In the one-way sensitivity analysis, the results were most sensitive to the utility value of incomplete control. The probabilistic sensitivity analysis revealed the probability that the ICER was below the willingness-to-pay, and the incremental QALYs was positive was 96.2%. The calculated cost of olanzapine per 5 mg that would make the incremental cost-effectiveness ratio equivalent to the threshold incremental cost-effectiveness ratio was calculated to be 475 JPY.
CONCLUSIONS
Olanzapine was cost-effective in the four-drug antiemetic therapy for Japanese patients treated with highly emetogenic cisplatin-containing chemotherapy.
PubMed: 35642015
DOI: 10.1186/s40780-022-00246-x -
Frontiers in Surgery 2022The present study is designed to study the analgesic and sedative effect of different doses of dexmedetomidine combined with butorphanol in continuous analgesia after a...
OBJECTIVE
The present study is designed to study the analgesic and sedative effect of different doses of dexmedetomidine combined with butorphanol in continuous analgesia after a cesarean section.
METHODS
A total of 60 puerperae undergoing a cesarean section recruited from a single center were divided into three groups according to the postoperative continuous analgesia protocol: control group (100 mL of normal saline containing 10 µg/kg fentanyl and 0.25 mg of palonosetron, 2 mL/h for continuous analgesia for 48 h), DB1 group (100 mL of normal saline containing 1.0 µg/kg dexmedetomidine, 4 mg of butorphanol, 10 µg/kg fentanyl, and 0.25 mg of palonosetron, 2 mL/h for continuous analgesia for 48 h), and DB2 group (100 mL normal saline containing 2.0 µg/kg dexmedetomidine, 4 mg of butorphanol, 10 µg/kg fentanyl, and 0.25 mg of palonosetron, 2 mL/h for continuous analgesia for 48 h). We compared the blood pressure, heart rate, oxygen saturation, VAS score, Ramsay score, and adverse reactions of puerperae among the three groups after surgery.
RESULTS
The baseline data all have no significant difference in the three groups ( > 0.05). Compared with those in the control group, the systolic blood pressure, diastolic blood pressure, heart rate, and VAS score of the puerperae in the DB1 group and DB2 group were significantly decreased at 6, 24, and 48 h ( < 0.05), while the Ramsay scores of the puerperae in DB1 group and DB2 group were significantly increased at 6, 24, and 48 h ( < 0.05). At the same time, the systolic blood pressure, diastolic blood pressure, heart rate, and VAS score of the puerperae in the DB2 group were significantly lower than those in the DB1 group ( < 0.05), while the Ramsay scores of the puerperae in DB2 group were significantly higher than those in the DB1 group ( < 0.05). Also, there is no significant difference in oxygen saturation and adverse reactions of puerperae among the three groups after surgery ( > 0.05).
CONCLUSION
Dexmedetomidine combined with butorphanol can improve the analgesic and sedative effects in continuous analgesia after a cesarean section, and the analgesic and sedative effects of dexmedetomidine in the high-dose group are better than those in the low-dose group.
PubMed: 35599801
DOI: 10.3389/fsurg.2022.896536 -
Current Cancer Drug Targets 2022Chemotherapy-induced nausea and vomiting (CINV) is a common adverse event associated with many anticancer therapies and can negatively impact patients' quality of life... (Review)
Review
Chemotherapy-induced nausea and vomiting (CINV) is a common adverse event associated with many anticancer therapies and can negatively impact patients' quality of life and potentially limit the effectiveness of chemotherapy. Currently, CINV can be prevented in most patients with guideline-recommended antiemetic regimens. However, clinicians do not always follow guidelines, and patients often face difficulties adhering to their prescribed treatments. Therefore, approaches to increase guideline adherence need to be implemented. NEPA is the first and only fixed combination antiemetic, composed of netupitant (oral)/fosnetupitant (intravenous) and palonosetron, which, together with dexamethasone, constitute a triple antiemetic combination recommended for the prevention of CINV for patients receiving highly emetogenic chemotherapy and for certain patients receiving moderately emetogenic chemotherapy. Thus, NEPA offers a convenient and straightforward antiemetic treatment that could improve adherence to guidelines. This review provides an overview of CINV, evaluates the accumulated evidence of NEPA's antiemetic activity and safety from clinical trials and real-world practice, and examines the preliminary evidence of antiemetic control with NEPA in daily clinical settings beyond those described in pivotal trials. Moreover, we review the utility of NEPA in controlling nausea and preserving patients' quality of life during chemotherapy, two major concerns in managing patients with cancer.
Topics: Antiemetics; Antineoplastic Agents; Benzeneacetamides; Dexamethasone; Humans; Nausea; Palonosetron; Piperazines; Pyridines; Quality of Life; Vomiting
PubMed: 35570542
DOI: 10.2174/1568009622666220513094352 -
Cureus Mar 2022Background Incidence of postoperative nausea and vomiting (PONV) in susceptible patients can be unacceptably high (70-80% reported incidence). This study was designed to...
Background Incidence of postoperative nausea and vomiting (PONV) in susceptible patients can be unacceptably high (70-80% reported incidence). This study was designed to evaluate the effect of palonosetron and ondansetron in preventing PONV in high-risk patients undergoing gynecological laparoscopic surgery. Methodology In this randomized, controlled, double-blind trial, non-smoking females aged 18-70 years, weighing 40-90 kg, and posted for elective laparoscopic gynecological surgeries were enrolled into ondansetron (Group A, n = 65) and palonosetron (Group B, n = 65) groups. Palonosetron (1 mcg/kg IV) or ondansetron (0.1 mg/kg IV) were administered just before induction. Postoperatively, the incidence of nausea, vomiting, PONV (scored on a scale of 0-3), need for rescue antiemetic, complete response, patient satisfaction, and adverse effects were evaluated up to 48 h following surgery. Normally distributed continuous variables were compared using Student's t-test. In addition, the Chi-squared test or Fisher's exact test were used to compare nominal categorical data as deemed appropriate. P-value <0.05 was observed as statistically significant. Results The overall PONV scores and postoperative nausea scores during 0-2 and 24-48 hours were comparable, but PONV scores (p = 0.023) and postoperative nausea scores (p = 0.010) during 2-24 hours were significantly lesser in Group B compared to Group A. There was no statistically significant difference in the postoperative vomiting score or retching during 0-48 hours. The amount of first-line rescue antiemetic used during 2-24 hours was significantly higher in Group A (56%) than in Group B (31%) (p = 0.012; p <0.05). A complete response to the drug during 2-24 hours was significantly higher (p = 0.023) in Group B (63%) compared to Group A (40%), whereas response was comparable during 0-2 and 24-48 hours. Both groups had a comparable incidence of adverse effects and patient satisfaction scores. Conclusion Palonosetron has a superior anti-nausea effect, less need for rescue antiemetics, and lesser incidence of total PONV compared to ondansetron during 2-24h and comparable effect to ondansetron during 0-2h and 24-48h postoperative period in high-risk patients undergoing gynecological laparoscopic surgery.
PubMed: 35505760
DOI: 10.7759/cureus.23615 -
Current Therapeutic Research, Clinical... 2022Spinal surgery is associated with severe pain within the first few days after surgery. Opioids are commonly used to control postoperative pain, but these can lead to... (Review)
Review
BACKGROUND
Spinal surgery is associated with severe pain within the first few days after surgery. Opioids are commonly used to control postoperative pain, but these can lead to postoperative nausea and vomiting (PONV). Therefore, use of more effective and better-tolerated agents would be beneficial for these patients. Serotonin receptor antagonists, such as ramosetron, have been used to reduce PONV in patients receiving anesthesia.
OBJECTIVE
We conducted a meta-analysis of published randomized controlled trials (RCTs) to compare the efficacy and tolerance of ramosetron to prevent PONV after spinal surgery.
METHODS
Medline, Embase, Cochrane Library, and Science Citation Index databases were systematically searched for relevant RCT articles published between January 1979 and November 2020. Full text articles restricted to English language that described RCTs comparing the use of ramosetron with other serotonin antagonists to treat PONV following spinal surgery in adult patients were considered for meta-analysis. Two reviewers independently performed study selection, quality assessment, and data extraction of all articles. Differences were resolved by a third reviewer.
RESULTS
The search identified 88 potentially relevant articles, of which only 3 met our selection criteria. Study drugs were administered at the end of spinal surgery in all 3 included articles. The meta-analysis revealed that ramosetron (0.3 mg) reduced the pain score (mean difference = -0.66; 95% CI -1.02 to -0.30), lowered the risk of PONV (risk ratio = 0.86; 95% CI, 0.76-0.97), and postoperative vomiting (risk ratio = 0.32; 95% CI, 0.17-0.60), and limited the use of rescue antiemetics (risk ratio = 0.66; 95% CI, 0.45-0.96) after spinal surgery. However, there were no significant differences in the incidence of postoperative nausea, the use of rescue pain medications, the number of rescue analgesics required, and the risk of discontinuation of patient-controlled analgesia between ramosetron and palonosetron (0.075 mg) or ondansetron (4 mg). There were no statistically significant differences in the risk of adverse events among the 3 medications.
CONCLUSIONS
This meta-analysis of 3 RCTs showed that ramosetron reduced the risk of PONV and POV, limited the use of rescue antiemetics, reduced the postoperative pain score, and did not increase the risk of discontinuing patient-controlled analgesia compared with palonosetron or ondansetron after spinal surgery in 3 RCTs. Therefore, this meta-analysis indicates that ramosetron is an effective and well tolerated antiemetic that can be used to prevent PONV following spinal surgery in adult patients. PROSPERO identifier: CRD42020223596 (. 2022; 83:XXX-XXX)© 2022 Elsevier HS Journals, Inc.
PubMed: 35464291
DOI: 10.1016/j.curtheres.2022.100666 -
Computational and Mathematical Methods... 2022Postoperative nausea and vomiting (PONV) is a typical and unpleasant physical symptom that occurs in patients after surgery, and it may be one of the most challenging... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Postoperative nausea and vomiting (PONV) is a typical and unpleasant physical symptom that occurs in patients after surgery, and it may be one of the most challenging elements of the recovery process. PONV can be caused by a variety of factors, including surgery itself, anesthesia, or medications. Palonosetron is a medication that is now licensed by the Food and Drug Administration for the treatment of this ailment. The efficacy of palonosetron in reducing physical symptoms in patients following surgery was investigated in this meta-analysis and comprehensive review.
METHODS
Following a quick search of databases such as CENTRAL, EMBASE, CINAHL, Google Scholar, the Science quotation index's Web site, the United States clinical trial check-in, the United Kingdom clinical trial check-in, the New Zealand clinical trial check-in, and the Australia check-in, as well as outlines of major anesthesia meetings held in the previous five years, we were able to get a good start on our research. Growing adults who had surgery and were given other drugs were compared to individuals who did get palonosetron in randomized controlled trials.
RESULTS
A total of 8324 participants were recruited in 10 different clinical studies. It has been shown that palonosetron may significantly reduce the 24-hour PONV incidence and 95% confidence interval (CI) 0.41-0.86. When comparing the 6-hour and 48-hour time periods, the incidences of experiencing PONV were neither statistically different (RR: 0.82, 95% confidence interval: 0.61-1.09) or considerably different (RR: 0.60, 95% confidence interval: 0.33-1.10). Following in a similar vein, there was no significant difference between the groups in the occurrence of PONV after 48 hours (RR: 0.82, 95 percent CI: 0.59-1.14). The most often reported side effects of the medicine were headaches and dizziness, which were the most common. Regardless of the drug used, the difference in adverse reactions was not statistically significant.
CONCLUSION
When it comes to the prevention of early PONV, it has been shown that palonosetron is more effective than other medications. Palonosetron, on the other hand, has been demonstrated to be more effective than other medications in preventing vomiting after laparoscopic surgery.
Topics: Adult; Anesthesia; Antiemetics; Humans; Laparoscopy; Palonosetron; Postoperative Nausea and Vomiting
PubMed: 35387223
DOI: 10.1155/2022/7474053 -
Frontiers in Medicine 2022Postoperative nausea and vomiting (PONV) gives patients a bad experience and negates their good recovery from surgery.
Transcutaneous Electrical Acupoint Stimulation Decreases the Incidence of Postoperative Nausea and Vomiting After Laparoscopic Non-gastrointestinal Surgery: A Multi-Center Randomized Controlled Trial.
IMPORTANCE
Postoperative nausea and vomiting (PONV) gives patients a bad experience and negates their good recovery from surgery.
OBJECTIVE
This trial aims to assess the preventive effectiveness of transcutaneous electrical acupoint stimulation (TEAS) on the incidence of PONV in high-risk surgical patients.
DESIGN
The large sample size, multicenter, evaluator-blinded, and randomized controlled study was conducted between September 3, 2019 to February 6, 2021.
SETTING
The 12 hospitals were from different Chinese provinces.
PARTICIPANTS
After obtaining ethics approval and written informed consent, 1,655 patients with Apfel score ≥ 3 points were enrolled for selective laparoscopic non-gastrointestinal surgery under general anesthesia.
INTERVENTIONS
Patients were randomly allocated into the TEAS and Sham group with a 1:1 ratio. The TEAS group was stimulated on bilateral Neiguan and Zusanli acupoints after recovery from anesthesia on the surgical day and the next morning for 30 min, while the Sham group received an identical setting as TEAS but without currents delivered. Electronic patient self-reported scale was used to evaluate and record the occurrence of PONV.
MAIN OUTCOMES AND MEASURES
Primary clinical end point is the incidence of PONV which was defined as at least one incidence of nausea, retching, or vomiting after operation within postoperative 24 h.
RESULTS
Compared with the Sham treatment, the TEAS lowered the PONV incidence by 4.8% (29.4 vs. 34.2%, = 0.036) and vomiting incidence by 7.4% (10.4 vs. 17.8%, < 0.001). TEAS also lowered persistent nausea incidence and PONV scores and decreased PONV related complications and Quality of Recovery-40 scores ( < 0.05). TEAS lowered the 24 h PONV risk by 20% (OR, 0.80, 95% CI, 0.65 -0.98; = 0.032), and lowered hazard ratio by 17% (HR, 0.83, 95% CI, 0.70-0.99; = 0.035). Both TEAS and palonosetron were the independent PONV risk protective factors for 24 h PONV incidence and cumulative PONV incidence. The combination of TEAS and palonosetron was the most effective strategy to reduce the PONV incidence ( < 0.001).
CONCLUSIONS AND RELEVANCE
TEAS attenuated the PONV incidence and severity in high-risk surgical patients and may be applied clinically as a complement therapy to prevent PONV.
CLINICAL TRIAL REGISTRATION
https://clinicaltrials.gov/ct2/show/NCT04043247, identifier: NCT04043247.
PubMed: 35360742
DOI: 10.3389/fmed.2022.766244