Randomized, double-blinded, placebo-controlled trial of ondansetron plus dexamethasone with or without metoclopramide as antiemetic prophylaxis in patients receiving high-dose cisplatin in medical practice

Ithimakin, Suthinee; Runglodvatana, Kanakorn; Nimmannit, Akarin; Akewanlop, Charuwan; Srimuninnimit, Vichien; Keerativitayanan, Narong; Soparattanapaisarn, Nopadol; Laocharoenkeat, Apirom

doi:10.1007/s00520-011-1162-4

Cited by 8 publications

(5 citation statements)

References 14 publications

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“…Selective 5-hydroxytryptamine type 3 (5-HT 3 ) receptor antagonists, including ondansetron (OND) (Figure 1(b)), granisetron (GRA) (Figure 1(c)), tropisetron (TRO) (Figure 1(d)), and azasetron (AZA) (Figure 1(e)), are effective and potent antiemetic drugs which are recommended by clinical practice guidelines for patients undergoing surgery and cancer chemotherapy [3–6]. Literature survey has revealed that coadministration of antiemetics from different classes could be a more effective antiemetic treatment modality, and DEX is a standard component of antiemetic combination regimens with 5-HT 3 antagonists [3, 7–10]. Hence, mixtures of 5-HT 3 receptor antagonists, alone or in combination with DEX, are often used in clinical practice to relieve chemotherapy induced nausea and vomiting.…”

Section: Introductionmentioning

confidence: 99%

Simultaneous Determination of Dexamethasone, Ondansetron, Granisetron, Tropisetron, and Azasetron in Infusion Samples by HPLC with DAD Detection

Chen

Wang

Guo

et al. 2017

Journal of Analytical Methods in Chemistry

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A simple and rapid high-performance liquid chromatography with diode array detector (HPLC-DAD) method has been developed and validated for simultaneous quantification of five antiemetic agents in infusion samples: dexamethasone, ondansetron, granisetron, tropisetron, and azasetron. The chromatographic separation was achieved on a Phenomenex C18 column (4.6 mm × 150 mm, 5 μm) using acetonitrile-50 mM KH2PO4 buffer-triethylamine (25 : 74 : 1; v/v; pH 4.0). Flow rate was 1.0 mL/min with a column temperature of 30°C. Validation of the method was made in terms of specificity, linearity, accuracy, and intra- and interday precision, as well as quantification and detection limits. The developed method can be used in the laboratory to routinely quantify dexamethasone, ondansetron, granisetron, tropisetron, and azasetron simultaneously and to evaluate the physicochemical stability of referred drugs in mixtures for endovenous use.

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Section: Introductionmentioning

confidence: 99%

Simultaneous Determination of Dexamethasone, Ondansetron, Granisetron, Tropisetron, and Azasetron in Infusion Samples by HPLC with DAD Detection

Chen

Wang

Guo

et al. 2017

Journal of Analytical Methods in Chemistry

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“…More specifically, the number of patients treated with protocol 1 who experienced delayed vomiting was higher compared with those receiving protocol 12. The sample size that was used for this assessment was small; nevertheless, the evidence presented in a study by Ithimakin et al 23 supports the notion that adding metoclopramide to ondansetron and dexamethasone does not significantly improve complete response rate, the proportion of patients who develop CINV, or the severity of CINV. This may be explained by the relatively low antiemetic potency of metoclopramide.…”

Section: Discussionmentioning

confidence: 91%

Effectiveness of antiemetic in reducing chemotherapy-induced nausea and vomiting in adult patients; An oncology center experience

Al-Salloum

AL-Harbi

Abdelazeem

2022

J Oncol Pharm Pract

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Introduction Chemotherapy-induced nausea and vomiting (CINV) are two serious adverse effect of cancer chemotherapy. The objectives of this study are to assess patient satisfaction with antiemetics prescribed, incidence of nausea and vomiting in cancer patients, and the effectiveness of antiemetic regimens in reducing CINV. Methods This is a prospective observational cross-sectional patient survey study, conducted between January and July 2021 in the oncology center at King Saud University Medical City, Riyadh, Saudi Arabia. A suitable, data entry form was designed to collect data including patient demographics, cancer type, antiemetics prescribed, chemotherapy regimen, and incidence of CINV. Results The sample comprised 283 cancer patients with a mean age of 47.7 (±14.6) years. Colorectal and breast cancer ( n = 67; 23.6%, for each) were the two most common diagnoses. Among the patients who received chemotherapy, most patients ( n = 144; 50.8%) received chemotherapy that was classified as highly emetogenic, and 139 (49%) received moderately emetogenic chemotherapy. Antiemetics were given to control CINV before chemotherapy administration (as prophylaxis) were either combination therapy (170 patients (60.0%) received four classes of antiemetics, 72 (25.4%) received three classes; and 31 (10.9%) received two classes) or monotherapy (six patients (2.1%) received one drug). Four patients (1.4%) did not receive any antiemetic medication. Antiemetics given to control CINV after chemotherapy administration (for delayed CINV) were also either in combination (151 patients (53.3%) received three classes of antiemetics and 94 (33.2%) received two classes) or as monotherapy, where 27 patients (9.5%) received one medication. Eleven patients (3.8%) did not receive any antiemetic. The incidence rates for acute and delayed nausea after chemotherapy treatment were 32.1% and 30.7%, respectively; and those for acute and delayed vomiting were 13.4% and 10.2%, respectively. Acute nausea was much more frequent than vomiting. Conclusion The incidence of CINV was relatively high, and patients who received chemotherapy continued to experience nausea and vomiting despite receiving antiemetic treatment. This demonstrates that antiemetic regimens used are not effective in preventing CINV.

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“…According to a systematic review and meta-analysis by Sert NP et al, the effect of ondansetron protection on CINV cisplatin of 5-10 mg/kgBW in experimental animals ranged from 70%, if ondansetron was given 30 minutes before chemotherapy with a repeat dose 2x daily. Ithimakin's clinical study found that the complete response (CR) ondansetron-dexamethasone antiemetic combination was 50% in cisplatin chemotherapy, 6 whereas Maemondo et al said the complete protection of the palonosetron-dexamethasone antiemetic therapy combination was 81.8%. 7 The results of statistical analysis on all levels of nausea and vomiting response according to Gralla classification in this study showed significant advantages of palonosetron-dexamethasone combinations.…”

Section: Resultsmentioning

confidence: 99%

“…5 The combination of palonosetron-dexamethasone prevents nausea and vomiting after cisplatin chemotherapy 81.8%, versus 50% when given with ondansetron-dexamethasone. 6,7 In the Division of Gynecology Oncology, Dr. Soetomo Hospital, Surabaya, prophylaxis after chemotherapy (CINV) provided for HEC and MEC is a combination of ondansetron-dexamethasone.…”

Section: Introductionmentioning

confidence: 99%

Combination of palonosetron-dexamethasone is more effective than ondansetron-dexamethasone as single cisplatin antiemetic chemotherapy

Putra

Suhatno

2018

MOG

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Objective: To know the efficacy differences between two groups of drug combination ondansetron-dexamethasone (A) and ondan-setron-dexamethasone (B) to prevent emetic rsponses after chemotherapy cisplatin administration (CINV).Materials and Methods: A prospective double blind randomized clinical trial study held in Dr. Soetomo General Hospital involving 66 subjects, devide into two groups randomly 33 patients each. One group receive palonosetron-dexamethasone combination therapy compare to ondansetron-dexamethasone combination as standart therapy in gynecologic oncology Dr. Soetomo Hospital in a control group as cisplatin chemotharapy CINV prophylaxis. The research was conducted from June till October 2014 in the Dr. Soetomo General Hospital-Surabaya. Assessment and measurement of the response of nausea and frequency of vomiting according Gralla scale, changes in plasma density and electrolyte serum (Na, K, and Cl) as a result of dehydration caused by nausea and vomiting, as well as counting the onset of nausea and vomiting occur.Results: There was significant differences between the results of the combination therapy compared ondansetron-dexamethasone to palonosetron-dexamethasone for nausea and vomiting (p=0,001). 31 subjects suffers nausea in ondansetron group, while 9 subjects suffers nausea in palonosetron group. Vomiting occurs in 17 subjects from ondansetron group, and only 1 subject from palono-setron group during study. Changes in plasma density significant in palonosetron group, and natrium in ondansetron group. For K and Cl not significantly difference in both groups before and after cisplatin chemotherapy administration.Conclusion: Palonosetron-dexamethasone combination is super-ior as cisplatin CINV prophylaxis in response to nausea and vomiting frequency, and also give longer protection compare to ondansetron-dexamethasone significantly. The plasma density and electrolyte serum changes are varied in numbers and also influenced by many factors including physical status and nutrition, also intake of each patients.

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Randomized, double-blinded, placebo-controlled trial of ondansetron plus dexamethasone with or without metoclopramide as antiemetic prophylaxis in patients receiving high-dose cisplatin in medical practice

Abstract: The addition of metoclopramide to ondansetron plus dexamethasone reduced the use of rescue medication, but did not affect complete response rate, quality of life or adverse effects.

Cited by 8 publications

References 14 publications

Simultaneous Determination of Dexamethasone, Ondansetron, Granisetron, Tropisetron, and Azasetron in Infusion Samples by HPLC with DAD Detection

Simultaneous Determination of Dexamethasone, Ondansetron, Granisetron, Tropisetron, and Azasetron in Infusion Samples by HPLC with DAD Detection

Effectiveness of antiemetic in reducing chemotherapy-induced nausea and vomiting in adult patients; An oncology center experience

Combination of palonosetron-dexamethasone is more effective than ondansetron-dexamethasone as single cisplatin antiemetic chemotherapy

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