Comparative trial of two intravenous doses of granisetron (1 versus 3 mg) in the prevention of chemotherapy-induced acute emesis: a double-blind, randomized, non-inferiority trial

Tsuji, Daiki; Kim, Yong‐Il; Taku, Keisei; Nakagaki, Shigeru; Ikematsu, Yoshito; Tsubota, Hiromi; Maeda, Masato; Hashimoto, Naoya; Kimura, Masayuki; Daimon, Takashi

doi:10.1007/s00520-011-1185-x

Cited by 11 publications

(3 citation statements)

References 25 publications

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“…In this trial, a maximum safe dose (3 mg every 8 h) in the instruction was administrated in the granisetron group. The single dose of granisetron in most of clinical trials was 3 mg ( Tsuji et al, 2012 ; Saito et al, 2013 ; Kitayama et al, 2015 ). For the effects of granisetron in inflammatory diseases, 3 mg of granisetron was also adopted in the clinical trial on temporomandibular joint arthritis ( Voog et al, 2004 ).…”

Section: Discussionmentioning

confidence: 99%

Adjunctive granisetron therapy in patients with sepsis or septic shock (GRANTISS): A single-center, single-blinded, randomized, controlled clinical trial

Guan

Liao²,

Guo³

et al. 2022

Front. Pharmacol.

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Background: In preclinical experiments, we demonstrated that the 5-HT3 receptor antagonist granisetron results in reduced inflammation and improved survival in septic mice. This randomized controlled trial was designed to assess the efficacy and safety of granisetron in patients with sepsis.Methods: Adult patients with sepsis and procalcitonin ≥ 2 ng/ml were randomized in a 1:1 ratio to receive intravenous granisetron (3 mg every 8 h) or normal saline at the same volume and frequency for 4 days or until intensive care unit discharge. The primary outcome was 28-day all-cause mortality. Secondary outcomes included the duration of supportive therapies for organ function, changes in sequential organ failure assessment scores over 96 h, procalcitonin reduction rate over 96 h, the incidence of new organ dysfunction, and changes in laboratory variable over 96 h. Adverse events were monitored as the safety outcome.Results: The modified intention-to-treat analysis included 150 septic patients. The 28-day all-cause mortalities in the granisetron and placebo groups were 34.7% and 35.6%, respectively (odds ratio, 0.96; 95% CI, 0.49–1.89). No differences were observed in secondary outcomes. In the subgroup analysis of patients without abdominal or digestive tract infections, the 28-day mortality in the granisetron group was 10.9% lower than mortality in the placebo group. Adverse events were not statistically different between the groups.Conclusion: Granisetron did not improve 28-day mortality in patients with sepsis. However, a further clinical trial targeted to septic patients without abdominal/digestive tract infections perhaps is worthy of consideration.

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Section: Discussionmentioning

confidence: 99%

Adjunctive granisetron therapy in patients with sepsis or septic shock (GRANTISS): A single-center, single-blinded, randomized, controlled clinical trial

Guan

Liao²,

Guo³

et al. 2022

Front. Pharmacol.

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“…de Orange et al [ 17 ] used dexamethasone at a dose of 150 mcg/kg in children, and we also used same dose in our study. Dose response relationship is another determinant of clinical effect of any drug; however, dose response relationship is questionable for granisetron both for PONV prophylaxis and for chemotherapy induced vomiting [ 18 , 19 ]. Similar findings have been reported with dexamethasone also; De Oliveira Jr. et al [ 20 ] in a meta-analysis found that 4 mg to 5 mg dose of dexamethasone seems to have similar clinical effects on the reduction of PONV as the 8 mg to 10 mg dose when dexamethasone was used as a single drug or as a combination therapy.…”

Section: Discussionmentioning

confidence: 99%

Granisetron versus Granisetron-Dexamethasone for Prevention of Postoperative Nausea and Vomiting in Pediatric Strabismus Surgery: A Randomized Double-Blind Trial

Saxena

Shende

Maitra

et al. 2016

Anesthesiology Research and Practice

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Aim. Efficacy of granisetron and combination of granisetron and dexamethasone was evaluated for prevention of postoperative nausea and vomiting (PONV) in children undergoing elective strabismus surgery. Methods. A total of 136 children (1–15 years) were included. Children received either granisetron (40 mcg/kg) [group G] or combination of granisetron (40 mcg/kg) and dexamethasone (150 mcg/kg) [group GD]. Intraoperative fentanyl requirement and incidence and severity of oculocardiac reflex were assessed. PONV severity was assessed for first 24 hours and if score was >2, it was treated with metoclopramide. Postoperative analgesia was administered with intravenous fentanyl and ibuprofen. Results. The demographic profile, muscles operated, and fentanyl requirement were comparable. Complete response to PONV in first 24 hours was observed in 75% (51/68) of children in group G and 76.9% (50/65) of children in group GD, which was comparable statistically (p = 0.96, Fisher exact test; OR 1.11, 95% CI 0.50, 2.46). Incidence of PONV between 0 and 24 hours was comparable. One child in group G required rescue antiemetic in first 24 hours and none of the children had severe PONV in group GD. There was no significant difference in incidence or severity of oculocardiac reflex. Conclusion. Dexamethasone did not increase efficacy of granisetron for prevention of PONV in elective pediatric strabismus surgery. Registration number of clinical trial was CTRI/2009/091/001000.

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“…Granisetron is a potent and highly selective serotonin receptor (5‐hydroxytryptamine‐3 selective) antagonist that is indicated for prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy (label approved by the US Food and Drug Administration). Extensive clinical trials have shown granisetron to be an effective and well‐tolerated agent for the treatment of nausea and vomiting in patients on chemotherapy (Gurpide et al ., ; Ikeda et al ., ; Tsuji et al ., ; Yonemura et al ., ) or in postoperative patients (Aleyasin et al ., ; Bestas et al ., ; Dua et al ., ; Janicki et al ., ). Additionally, it has been reported that the major metabolite of granisetron in human, 7‐hydroxy granisetron (Bloomer et al ., ; Clarke et al ., ), may also have 5‐hydroxytryptamine‐3 receptor antagonist activity (Boppana ; Boppana et al ., ).…”

Section: Introductionmentioning

confidence: 97%

Development and validation of a sensitive liquid chromatographic–tandem mass spectrometric method for the simultaneous analysis of granisetron and 7‐hydroxy granisetron in human plasma and urine samples: application in a clinical pharmacokinetic study in pregnant subject

Zhao

Chen

Caritis

et al. 2015

Biomedical Chromatography

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A liquid chromatography-tandem mass spectrometric method for the quantification of granisetron and its major metabolite, 7-hydroxy granisetron in human plasma and urine samples was developed and validated. Respective stable isotopically labeled granisetron and 7-hydroxy granisetron were used as internal standards (IS). Chromatography was performed using an Xselect HSS T3 analytical column with a mobile phase of 20% acetonitrile in water (containing 0.2 mM ammonium formate and 0.14% formic acid, pH 4) delivered in an isocratic mode. Tandem mass spectrometry operating in positive electrospray ionization mode with multiple reaction monitoring was used for quantification. The standard curves were linear in the concentration ranges of 0.5-100 ng/mL for granisetron and 0.1-100 ng/mL for 7-hydroxy granisetron in human plasma samples, and 2-2000 ng/mL for granisetron and 2-1000 ng/mL for 7-hydroxy granisetron in human urine samples, respectively. The accuracies were >85% and the precision as determined by the coefficient of variations was <10%. No significant matrix effects were observed for granisetron or 7-hydroxy granisetron in either plasma or urine samples. Granisetron was stable under various storage and experimental conditions. This validated method was successfully applied to a pharmacokinetic study after intravenous administration of 1 mg granisetron to a pregnant subject.

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Comparative trial of two intravenous doses of granisetron (1 versus 3 mg) in the prevention of chemotherapy-induced acute emesis: a double-blind, randomized, non-inferiority trial

Abstract: This study showed that 1 mg granisetron is not inferior to 3 mg when both doses are combined with dexamethasone. Therefore, 1-mg dose of intravenous granisetron should be the recommended prophylactic regimen for the prevention of acute emesis.

Cited by 11 publications

References 25 publications

Adjunctive granisetron therapy in patients with sepsis or septic shock (GRANTISS): A single-center, single-blinded, randomized, controlled clinical trial

Adjunctive granisetron therapy in patients with sepsis or septic shock (GRANTISS): A single-center, single-blinded, randomized, controlled clinical trial

Granisetron versus Granisetron-Dexamethasone for Prevention of Postoperative Nausea and Vomiting in Pediatric Strabismus Surgery: A Randomized Double-Blind Trial

Development and validation of a sensitive liquid chromatographic–tandem mass spectrometric method for the simultaneous analysis of granisetron and 7‐hydroxy granisetron in human plasma and urine samples: application in a clinical pharmacokinetic study in pregnant subject

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