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In Switzerland, approximately 32,000 patients are hospitalized annually due to adverse drug reactions (ADRs), representing 2.3% of all hospitalizations. During the perioperative period, the administration of a variety of drugs from different classes over a relatively short period of time increases the risk of ADR. Here, we describe the case of a 32-year-old woman who was administered droperidol to treat nausea in the recovery room after a myomectomy and who subsequently became comatose. Correctable metabolic, respiratory, and cerebrovascular disorders were ruled out. Six hours after the event, she was extubated without residual effects. We discuss potential ADR for droperidol.
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Coma , Droperidol , Miomectomía Uterina , Humanos , Femenino , Adulto , Droperidol/efectos adversos , Droperidol/administración & dosificación , Coma/inducido químicamente , Miomectomía Uterina/efectos adversos , Antieméticos/efectos adversos , Antieméticos/administración & dosificación , SuizaRESUMEN
Postoperative nausea and vomiting (PONV) is a common adverse effect of anesthesia. Identifying risk factors for PONV is crucial because it is associated with a longer stay in the post-anesthesia care unit, readmissions, and perioperative costs. This retrospective study used artificial intelligence to analyze data of 37,548 adult patients (aged ≥20 years) who underwent surgery under general anesthesia at Tohoku University Hospital from January 1, 2010 to December 31, 2019. To evaluate PONV, patients who experienced nausea and/or vomiting or used antiemetics within 24 hours after surgery were extracted from postoperative medical and nursing records. We create a model that predicts probability of PONV using the gradient tree boosting model, which is a widely used machine learning algorithm in many applications due to its efficiency and accuracy. The model implementation used the LightGBM framework. Data were available for 33,676 patients. Total blood loss was identified as the strongest contributor to PONV, followed by sex, total infusion volume, and patient's age. Other identified risk factors were duration of surgery (60-400 min), no blood transfusion, use of desflurane for maintenance of anesthesia, laparoscopic surgery, lateral positioning during surgery, propofol not used for maintenance of anesthesia, and epidural anesthesia at the lumbar level. The duration of anesthesia and the use of either sevoflurane or fentanyl were not identified as risk factors for PONV. We used artificial intelligence to evaluate the extent to which risk factors for PONV contribute to the development of PONV. Intraoperative total blood loss was identified as the potential risk factor most strongly associated with PONV, although it may correlate with duration of surgery, and insufficient circulating blood volume. The use of sevoflurane and fentanyl and the anesthesia time were not identified as risk factors for PONV in this study.
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Aprendizaje Automático , Náusea y Vómito Posoperatorios , Humanos , Náusea y Vómito Posoperatorios/etiología , Náusea y Vómito Posoperatorios/epidemiología , Masculino , Femenino , Factores de Riesgo , Persona de Mediana Edad , Adulto , Estudios Retrospectivos , Anciano , Anestesia General/efectos adversos , Antieméticos/uso terapéutico , Antieméticos/efectos adversosRESUMEN
STUDY OBJECTIVE: Postoperative nausea and vomiting (PONV) is a common sequela of surgery in patients undergoing general anesthesia. Amisulpride has shown promise in its ability to treat PONV. The objective of this study was to determine if amisulpride is associated with significant changes in PACU efficiency within a fast-paced ambulatory surgery center. METHODS: This was a retrospective cohort study of 816 patients at a single ambulatory surgery center who experienced PONV between 2018 and 2023. The two cohorts analyzed were patients who did or did not have amisulpride among their anti-emetic regimens in the PACU during two distinct time periods (before and after amisulpride was introduced). The primary outcome of the study was PACU length of stay. Both unmatched analysis and a linear multivariable mixed-effects model fit by restricted maximum likelihood (random effect being surgical procedure) were used to analyze the association between amisulpride and PACU length of stay. We performed segmented regression to account for cohorts occurring during two time periods. RESULTS: Unmatched univariate analysis revealed no significant difference in PACU length of stay (minutes) between the amisulpride and no amisulpride cohorts (115 min vs 119 min, respectively; P = 0.07). However, when addressing confounders by means of the mixed-effects multivariable segmented regression, the amisulpride cohort was associated with a statistically significant reduction in PACU length of stay by 26.1 min (P < 0.001). CONCLUSIONS: This study demonstrated that amisulpride was associated with a significant decrease in PACU length of stay among patients with PONV in a single outpatient surgery center. The downstream cost-savings and operational efficiency gained from this drug's implementation may serve as a useful lens through which this drug's widespread implementation may further be rationalized.
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Procedimientos Quirúrgicos Ambulatorios , Amisulprida , Antieméticos , Tiempo de Internación , Náusea y Vómito Posoperatorios , Humanos , Náusea y Vómito Posoperatorios/epidemiología , Femenino , Masculino , Tiempo de Internación/estadística & datos numéricos , Estudios Retrospectivos , Persona de Mediana Edad , Amisulprida/administración & dosificación , Amisulprida/efectos adversos , Procedimientos Quirúrgicos Ambulatorios/efectos adversos , Adulto , Antieméticos/uso terapéutico , Antieméticos/administración & dosificación , Antieméticos/efectos adversos , Sala de Recuperación/estadística & datos numéricos , Anciano , Anestesia General/efectos adversos , Anestesia General/métodos , Resultado del Tratamiento , Periodo de Recuperación de la AnestesiaRESUMEN
INTRODUCTION: Dopamine (D)2,3-receptor antagonists (RAs) were the first antiemetics used in the prophylaxis of chemotherapy-induced nausea and vomiting (CINV). AREAS COVERED: Eight D2,3-RAs, amisulpride, domperidone, droperidol, haloperidol, metoclopramide, metopimazine, olanzapine and prochlorperazine are reviewed focusing on pharmacokinetics, pharmacodynamics, antiemetic effect and side effects. EXPERT OPINION: Since the introduction of D2,3-RAs, antiemetics such as corticosteroids, 5-hydroxytryptamine (5-HT)3-RAs and neurokinin (NK)1-RAs have been developed. The classical D2,3-RAs are recommended in the prophylaxis of CINV from low emetic risk chemotherapy, but not as a fixed component of an antiemetic regimen for moderately or highly (HEC) emetic risk chemotherapy. D2,3-RAs are also used in patients with breakthrough nausea and vomiting. It should be emphasized, that most of these drugs are not selective for dopamine receptors.The multi-receptor targeting agent, olanzapine, is recommended in the prophylaxis of HEC-induced CINV as part of a four-drug antiemetic regimen, including a 5-HT3-RA, dexamethasone and a NK1-RA. Olanzapine is the most effective agent to prevent chemotherapy-induced nausea.Side effects differ among various D2,3-RAs. Metopimazine and domperidone possess a low risk of extrapyramidal side effects. Domperidone and metoclopramide are prokinetics, whereas metopimazine delays gastric emptying and haloperidol does not influence gastric motility. Many D2,3-RAs increase the risk of prolonged QTc interval; other side effects include sedation and orthostatic hypotension.
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Antieméticos , Antineoplásicos , Antagonistas de Dopamina , Náusea , Vómitos , Humanos , Náusea/inducido químicamente , Náusea/prevención & control , Vómitos/inducido químicamente , Vómitos/prevención & control , Antieméticos/farmacología , Antieméticos/farmacocinética , Antieméticos/administración & dosificación , Antieméticos/efectos adversos , Antineoplásicos/efectos adversos , Antineoplásicos/farmacocinética , Antineoplásicos/administración & dosificación , Antagonistas de Dopamina/efectos adversos , Antagonistas de Dopamina/farmacología , Antagonistas de Dopamina/farmacocinética , Antagonistas de Dopamina/administración & dosificación , Animales , Antagonistas de los Receptores de Dopamina D2/efectos adversos , Antagonistas de los Receptores de Dopamina D2/farmacología , Receptores de Dopamina D3/antagonistas & inhibidoresAsunto(s)
Ondansetrón , Diálisis Renal , Humanos , Ondansetrón/farmacocinética , Ondansetrón/uso terapéutico , Ondansetrón/efectos adversos , Antieméticos/farmacocinética , Antieméticos/efectos adversos , Antieméticos/uso terapéutico , Fallo Renal Crónico/terapia , Fallo Renal Crónico/complicacionesAsunto(s)
Ondansetrón , Diálisis Renal , Humanos , Ondansetrón/efectos adversos , Ondansetrón/uso terapéutico , Ondansetrón/farmacocinética , Antieméticos/efectos adversos , Antieméticos/farmacocinética , Antieméticos/uso terapéutico , Fallo Renal Crónico/terapia , Fallo Renal Crónico/complicacionesRESUMEN
PURPOSE: Chemotherapy-induced nausea and vomiting (CINV) is a common adverse events in cancer patients and can negatively affect their quality of life (QoL). This study aimed to evaluate the clinical efficacy of an electric massage chair (EMC) for the treatment of CINV. METHODS: A randomized phase II cross-over trial was conducted on solid cancer patients who received moderate (MEC) to high emetogenic chemotherapy (HEC). The participants were randomly assigned to receive their first chemotherapy either on a standard bed (Group A) or in an EMC (Group B) during the infusion. The patients were then crossed over to the next cycle. CINV and QoL questionnaires were collected from the participants. RESULTS: A total of 59 patients completed the trial protocol and were included in the analysis, with 29 and 30 patients in Groups A and B, respectively. The mean INVR (Index of Nausea, Vomiting, and Retching) score in the 2nd day of the first cycle was higher in Group B (3.63 ± 5.35) than Group A (2.76 ± 4.78), but the difference was not statistically significant (p = 0.5367). The complete response rate showed little difference between the groups. Among the high-emetic risk subgroups, patients who received HEC (p = 0.04595), younger patients (p = 0.0108), and non-colorectal cancer patients (p = 0.0495) presented significantly lower CINV scores when EMC was applied. CONCLUSION: Overall, there was no significant difference in INVR scores between standard care and EMC. Applying EMC at the first chemotherapy infusion may help preserve QoL and reduce CINV in high-risk patients. TRIAL REGISTRATION: KCT0008200, 17/02/2023, Retrospectively registered.
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Antieméticos , Antineoplásicos , Neoplasias , Humanos , Calidad de Vida , Antieméticos/uso terapéutico , Antieméticos/efectos adversos , Estudios Cruzados , Vómitos/terapia , Vómitos/tratamiento farmacológico , Náusea/terapia , Náusea/tratamiento farmacológico , Neoplasias/tratamiento farmacológico , Antineoplásicos/efectos adversosRESUMEN
SummaryCannabis use is legalised in many countries. We present a patient in their 40s who complained of recurrent abdominal pain and associated nausea and vomiting. The patient was previously seen in various hospitals, treated symptomatically, and discharged with a diagnosis of non-specific abdominal pain. The patient had a chronic history of smoking cannabis and nicotine and drinking alcohol. Abdominal examination revealed no masses, and abdominal X-ray was normal. Blood tests and gastroduodenoscopy revealed no obvious aetiology. Intravenous fluids, together with antiemetics and proton pump inhibitors, were administered. The patient also received counselling and was advised to stop cannabis use. At discharge, the patient was well and asked to come back for review in 2 weeks, and, thereafter monthly for a period of 6 months after stopping cannabis use. The patient reported no recurrent symptoms despite continued cigarette and alcohol use. A suspected cannabinoid hyperemesis syndrome (CHS) became a consideration. Awareness of cannabis-related disorders such as CHS may assist in avoiding costly hospital workups.
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Dolor Abdominal , Síndrome de Hiperemesis Cannabinoide , Cannabinoides , Vómitos , Adulto , Humanos , Masculino , Dolor Abdominal/inducido químicamente , Antieméticos/efectos adversos , Síndrome de Hiperemesis Cannabinoide/complicaciones , Cannabinoides/efectos adversos , Náusea/inducido químicamente , Vómitos/inducido químicamenteRESUMEN
BACKGROUND: Postoperative nausea and vomiting (PONV) refers to nausea and vomiting that occurs within 24-h after surgery or in the post-anesthesia care unit (PACU). Previous studies have reported that the use of remimazolam, a newer benzodiazepine (BDZ) hypnotic, for anesthesia results in less PONV. In this study, we compared the rate of PONV between sevoflurane and remimazolam after general anesthesia. METHODS: In this prospective randomized controlled trial, participants aged 20-80 years who underwent elective laparoscopic cholecystectomy or hemicolectomy were randomized to either the remimazolam or sevoflurane group. The primary outcome was PONV incidence for 24-h after surgery. Secondary outcomes comprised of PONV at 30-min post-surgery, postoperative additional antiemetic use, and Quality of Recovery-15 (QOR-15) score at 24-h postoperatively. RESULTS: Forty patients were enrolled in the study. The remimazolam group exhibited significantly lower rates of PONV for 24-h after surgery than did the sevoflurane group (remimazolam group vs. sevoflurane group; 5% vs. 45%, P = 0.003, respectively). The use of dexamethasone, a rescue antiemetic administered within 24 h of surgery, was substantially lower in the remimazolam group than in the sevoflurane group (0% in remimazolam vs. 30% in sevoflurane, P = 0.020). The QOR-15 score at 24-h after surgery showed no significant difference between the two groups. CONCLUSIONS: Compared to sevoflurane, opting for remimazolam as an intraoperative hypnotic may decrease the incidence of PONV and reduce antiemetic use for 24 h after laparoscopic surgery.
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Anestesia General , Anestésicos por Inhalación , Náusea y Vómito Posoperatorios , Sevoflurano , Humanos , Náusea y Vómito Posoperatorios/prevención & control , Náusea y Vómito Posoperatorios/epidemiología , Sevoflurano/administración & dosificación , Sevoflurano/efectos adversos , Persona de Mediana Edad , Masculino , Femenino , Estudios Prospectivos , Anciano , Adulto , Incidencia , Anestesia General/efectos adversos , Anestesia General/métodos , Anestésicos por Inhalación/efectos adversos , Anestésicos por Inhalación/administración & dosificación , Benzodiazepinas/efectos adversos , Benzodiazepinas/administración & dosificación , Anciano de 80 o más Años , Antieméticos/administración & dosificación , Antieméticos/efectos adversos , Adulto Joven , Hipnóticos y Sedantes/administración & dosificación , Hipnóticos y Sedantes/efectos adversosRESUMEN
Nausea and vomiting are primitive aspects of mammalian physiology and behavior that ensure survival. Unfortunately, both are ubiquitously present side effects of drug treatments for many chronic diseases with negative consequences on pharmacotherapy tolerance, quality of life, and prognosis. One of the most critical clinical examples is the profound emesis and nausea that occur in patients undergoing chemotherapy, which continue to be among the most distressing side effects, even with the use of modern antiemetic medications. Similarly, antiobesity/diabetes medications that target the glucagon-like peptide-1 system, despite their remarkable metabolic success, also cause nausea and vomiting in a significant number of patients. These side effects hinder the ability to administer higher dosages for optimal glycemic and weight management and represent the major reasons for treatment discontinuation. Our inability to effectively control these side effects highlights the need to anatomically, molecularly, and functionally characterize novel neural substrates that drive and inhibit nausea and emesis. Here, we discuss clinical and preclinical evidence that highlights the glucose-dependent insulinotropic peptide receptor system as a novel therapeutic central target for the management of nausea and emesis.
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Antieméticos , Receptores de la Hormona Gastrointestinal , Animales , Humanos , Antieméticos/efectos adversos , Vómitos/inducido químicamente , Vómitos/tratamiento farmacológico , Calidad de Vida , Náusea/inducido químicamente , Náusea/tratamiento farmacológico , MamíferosAsunto(s)
Muerte Súbita Cardíaca , Ondansetrón , Diálisis Renal , Humanos , Diálisis Renal/efectos adversos , Muerte Súbita Cardíaca/etiología , Ondansetrón/uso terapéutico , Ondansetrón/efectos adversos , Masculino , Femenino , Persona de Mediana Edad , Fallo Renal Crónico/terapia , Fallo Renal Crónico/complicaciones , Fallo Renal Crónico/mortalidad , Antieméticos/efectos adversos , Antieméticos/uso terapéutico , AncianoRESUMEN
BACKGROUND: Automatic monitoring and assessment are increasingly employed in drug safety evaluations using hospital information system data. The increasing concern about granisetron-related arrhythmias requires real-world studies to improve our understanding of its safety. AIM: This study aimed to analyze the incidence, clinical characteristics, and risk factors of granisetron-related arrhythmias in hospitalized patients using real-world data obtained from the Adverse Drug Event Active Surveillance and Assessment System-II (ADE-ASAS-II) and concurrently aimed to develop and validate a nomogram to predict the occurrence of arrhythmias. METHOD: Retrospective automatic monitoring of inpatients using granisetron was conducted in a Chinese hospital from January 1, 2017, to December 31, 2021, to determine the incidence of arrhythmias using ADE-ASAS- II. Propensity score matching was used to balance confounders and analyze clinical characteristics. Based on risk factors identified through logistic regression analysis, a prediction nomogram was established and internally validated using the Bootstrap method. RESULTS: Arrhythmias occurred in 178 of 72,508 cases taking granisetron with an incidence of 0.3%. Independent risk factors for granisetron-related arrhythmias included medication duration, comorbid cardiovascular disease, concomitant use of other 5-hydroxytryptamine 3 receptor antagonists, alanine aminotransferase > 40 U/L, and blood urea nitrogen > 7.5 mmol/L. The nomogram demonstrated good differentiation and calibration, with enhanced clinical benefit observed when the risk threshold ranged from 0.10 to 0.82. CONCLUSION: The nomogram, based on the five identified independent risk factors, may be valuable in predicting the risk of granisetron-related arrhythmias in the administered population, offering significant clinical applications.
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Arritmias Cardíacas , Granisetrón , Nomogramas , Humanos , Granisetrón/efectos adversos , Femenino , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Arritmias Cardíacas/inducido químicamente , Arritmias Cardíacas/epidemiología , Anciano , Estudios de Casos y Controles , Factores de Riesgo , Incidencia , Adulto , China/epidemiología , Antieméticos/efectos adversos , Sistemas de Registro de Reacción Adversa a Medicamentos/estadística & datos numéricos , Anciano de 80 o más AñosRESUMEN
INTRODUCTION: In opioid therapy for cancer pain, opioid-induced nausea and vomiting (OINV) occur in 20%-40% of patients during initial opioid treatment or increasing opioid doses. OINV result in failure to achieve pain relief due to poor opioid adherence. Therefore, antiemetics are used to prevent OINV, but their efficacy and safety in this context have not yet been fully elucidated. Olanzapine is a promising antiemetic for the prophylaxis of chemotherapy-induced nausea and vomiting. METHODS AND ANALYSIS: This single-arm, single-centre exploratory study will evaluate the prophylactic antiemetic efficacy and safety of 5 mg olanzapine in patients with cancer pain who are withholding initial regular opioid therapy. Thirty-five patients will be enrolled. The primary endpoint is the proportion of patients achieving complete control (CC) of OINV during 5 days of opioid treatment. CC was defined as the absence of emetic episodes, no need for rescue medication to treat nausea, and minimal or no nausea (3 or less on an 11-point categorical scale). Secondary endpoints include the complete response, defined as no emetic episodes and no use of rescue medication during the overall assessment period, the time from opioid initiation to first emetic episode, the time from opioid initiation to first rescue antiemetic administration, and adverse events graded by Patient-Reported Outcome (PRO) Common Terminology Criteria for Adverse Events (CTCAE) version 1.0 and CTCAE version 5.0. ETHICS AND DISSEMINATION: This study protocol was approved by National Cancer Center Hospital Certified Review Board. The results will be used as preliminary data to conduct a validation study. TRIAL REGISTRATION NUMBER: Japan Registry of Clinical Trials (jRCT) jRCTs031220008.
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Antieméticos , Dolor en Cáncer , Humanos , Antieméticos/efectos adversos , Olanzapina/uso terapéutico , Analgésicos Opioides/efectos adversos , Eméticos/efectos adversos , Dolor en Cáncer/tratamiento farmacológico , Vómitos/inducido químicamente , Vómitos/tratamiento farmacológico , Vómitos/prevención & control , Náusea/inducido químicamente , Náusea/prevención & control , Náusea/tratamiento farmacológicoRESUMEN
NK-1 receptor antagonists (NK1-RA) are key agents for chemotherapy-induced nausea and vomiting (CINV) prevention in patients receiving highly emetogenic chemotherapy. Current pediatric practice guidelines recommend the use of intravenous fosaprepitant or oral aprepitant. However, there are reports of hypersensitivity reactions with fosaprepitant due to polysorbate 80. Intravenous aprepitant does not contain polysorbate 80, but its use in pediatric patients has not been described. In this retrospective, single-center study, 106 pediatric patients received either fosaprepitant or intravenous aprepitant as part of their antiemetic regimen. Intravenous aprepitant was well tolerated and did not lead to any instances of hypersensitivity reactions requiring discontinuation.
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Antieméticos , Antineoplásicos , Hipersensibilidad , Morfolinas , Neoplasias , Humanos , Niño , Aprepitant/uso terapéutico , Estudios Retrospectivos , Polisorbatos/efectos adversos , Antineoplásicos/efectos adversos , Antieméticos/efectos adversos , Vómitos/inducido químicamente , Vómitos/prevención & control , Vómitos/tratamiento farmacológico , Neoplasias/complicaciones , Neoplasias/tratamiento farmacológicoRESUMEN
AIM: Patients with cancer often experience nausea and vomiting (N/V), but may have difficulty using olanzapine (OLZ), a common antiemetic. Asenapine (ASE) is a multi-acting receptor-targeted antipsychotic like OLZ, although there is little evidence that ASE serves as an antiemetic. The aim of this study was to evaluate the efficacy and tolerability of ASE compared to those of OLZ for the treatment of N/V in patients with cancer. METHODS: This retrospective study involved patients who received 5 mg ASE, 5 mg OLZ, or 2.5 mg OLZ for 2 days. Daily worst N/V was rated on a scale of 0 (none) to 3 (very much). The primary endpoint was the proportion of patients who had a response, defined as any reduction in N/V score. A complete response (CR) was defined as a score reduction to 0. Secondary endpoints included the proportion of patients with CR and adverse events. RESULTS: Between April 2017 and March 2023, 212 patients were enrolled to receive treatment: 5 mg ASE (n = 34), 5 mg OLZ (n = 102), or 2.5 mg OLZ (n = 76). No significant differences in response rates (52.9% vs. 58.8% vs. 52.6%, p = 0.671) or secondary endpoints were observed between the groups. Patients receiving ASE were more likely to experience oral hypoesthesia (p = 0.004). CONCLUSION: This preliminary study suggests that ASE may be effective for N/V. Further studies are required to confirm these findings.
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Antieméticos , Dibenzocicloheptenos , Neoplasias , Humanos , Olanzapina , Antieméticos/efectos adversos , Estudios Retrospectivos , Vómitos/inducido químicamente , Vómitos/tratamiento farmacológico , Náusea/inducido químicamente , Náusea/tratamiento farmacológico , Neoplasias/inducido químicamenteRESUMEN
BACKGROUND: Olanzapine is an effective antiemetic agent but it results in substantial daytime somnolence when administered at the standard dose. Our aim was to compare the efficacy of low-dose versus standard-dose olanzapine after highly emetogenic chemotherapy in patients with solid tumours. METHODS: This was a single-centre, open-label, non-inferiority, randomised, controlled, phase 3 trial done in a tertiary care referral centre in India (Tata Memorial Centre, Homi Bhabha National Institute, Mumbai). Patients aged 13-75 years with an Eastern Cooperative Oncology Group performance status of 0-2, who were receiving doxorubicin-cyclophosphamide or high-dose cisplatin for a solid tumour were eligible. Patients were randomly assigned (1:1), with block randomisation (block sizes of 2 or 4) and stratified by sex, age (≥55 or <55 years), and chemotherapy regimen, to receive low-dose (2·5 mg) oral olanzapine or standard-dose (10·0 mg) oral olanzapine daily for 4 days, in combination with a triple antiemetic regimen. Study staff were masked to treatment allocation but patients were aware of their group assignment. The primary endpoint was complete control, defined as no emetic episodes, no rescue medications, and no or mild nausea in the overall phase (0-120 hours), assessed in the modified intention-to-treat (mITT) population (ie, all eligible patients who received protocol-specified treatment, excluding those who had eligibility violations and who withdrew consent after randomisation). Daytime somnolence was the safety endpoint of interest. Non-inferiority was shown if the upper limit of the one-sided 95% CI for the difference in the complete control proportions between the treatment groups excluded the non-inferiority margin of 10%. This study is registered with the Clinical Trial Registry India, CTRI/2021/01/030233, is closed to accrual, and this is the final data analysis. RESULTS: Between Feb 9, 2021, and May 30, 2023, 356 patients were pre-screened for eligibility, of whom 275 patients were enrolled and randomly assigned (134 to the 2·5 mg olanzapine group and 141 to the 10·0 mg olanzapine group). 267 patients (132 in the 2·5 mg group and 135 in the 10·0 mg group) were included in the mITT population, of whom 252 (94%) were female, 15 (6%) were male, and 242 (91%) had breast cancer. 59 (45%) of 132 patients in the 2·5 mg olanzapine group had complete control in the overall phase versus 59 (44%) of 135 in the 10·0 mg olanzapine group (difference -1·0% [one-sided 95% CI -100·0 to 9·0]; p=0·87). In the overall phase, there were significantly fewer patients in the 2·5 mg olanzapine group than in the 10·0 mg olanzapine group with daytime somnolence of any grade (86 [65%] of 132 vs 121 [90%] of 135; p<0·0001) and of severe grade on day 1 (six]5%] vs 54 [40%]; p<0·0001). INTERPRETATION: Our findings suggest that olanzapine 2·5 mg is non-inferior to 10·0 mg in antiemetic efficacy and results in reduced occurrence of daytime somnolence among patients receiving highly emetic chemotherapy and should be considered as a new standard of care. FUNDING: Progressive Ladies Welfare Association.
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Antieméticos , Antineoplásicos , Neoplasias de la Mama , Trastornos de Somnolencia Excesiva , Femenino , Humanos , Masculino , Antieméticos/efectos adversos , Antineoplásicos/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Trastornos de Somnolencia Excesiva/inducido químicamente , Trastornos de Somnolencia Excesiva/tratamiento farmacológico , Náusea/inducido químicamente , Náusea/prevención & control , Olanzapina/efectos adversos , Vómitos/inducido químicamente , Vómitos/prevención & control , Vómitos/tratamiento farmacológicoRESUMEN
Objective The effect of Rikkunshito, a Japanese herbal Kampo medicine, on chemotherapy-induced nausea and vomiting (CINV) has been evaluated in several small prospective studies, with mixed results. We retrospectively evaluated the antiemetic effects of Rikkunshito in patients undergoing cisplatin-based chemotherapy using a large-scale database in Japan. Methods The Diagnosis Procedure Combination inpatient database from July 2010 to March 2019 was used to compare adult patients with malignant tumors who had received Rikkunshito on or before the day of cisplatin administration (Rikkunshito group) and those who had not (control group). Antiemetics on days 2 and 3 and days 4 and beyond following cisplatin administration were used as surrogate outcomes for CINV. Patient backgrounds were adjusted using the stabilized inverse probability of treatment weighting, and outcomes were compared using univariable regression models. Results We identified 669 and 123,378 patients in the Rikkunshito and control groups, respectively. There were significantly fewer patients using intravenous 5-HT3-receptor antagonists in the Rikkunshito group (odds ratio, 0.38; 95% confidence interval, 0.16-0.87; p=0.023) on days 2 and 3 of cisplatin-based chemotherapy. Conclusion The reduced use of antiemetics on day 2 and beyond of cisplatin administration suggested a beneficial effect of Rikkunshito in palliating the symptoms of CINV.