Effect of single doses of IV palonosetron, up to 2.25 mg, on the QTc interval duration: a double-blind, randomized, parallel group study in healthy volunteers

Morganroth, Joel; Flaharty, Kristen K.; Parisi, Simona; Moresino, Cecilia

doi:10.1007/s00520-015-2822-6

Cited by 17 publications

(13 citation statements)

References 30 publications

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Section: Discussionmentioning

confidence: 99%

“…A study by Morganroth et al included 221 healthy subjects who were assigned to receive one of the following five treatments: placebo, palonosetron (0.25, 0.75, or 2.25 mg), or moxifloxacin (400 mg) in order to study the effects of palonosetron on QTc interval ( 29 ). All three doses of palonosetron showed no significant effects on QTc prolongation ( 29 ). The main objective of the study was developed in accordance with the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E14 in order to analyze the potential of cardiovascular toxicity ( 29 ).…”

Section: Discussionmentioning

confidence: 99%

“…The main objective of the study was developed in accordance with the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E14 in order to analyze the potential of cardiovascular toxicity ( 29 ). No significant QTc prolongations were detected ( 29 ). This supports our results for QTc prolongation.…”

Section: Discussionmentioning

confidence: 99%

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The Effect of a Combination Treatment Using Palonosetron, Promethazine, and Dexamethasone on the Prophylaxis of Postoperative Nausea and Vomiting and QTc Interval Duration in Patients Undergoing Craniotomy under General Anesthesia: A Pilot Study

et al. 2016

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IntroductionPostoperative nausea and vomiting (PONV) is a displeasing experience that distresses surgical patients during the first 24 h after a surgical procedure. The incidence of postoperative nausea occurs in about 50%, the incidence of postoperative vomiting is about 30%, and in high-risk patients, the PONV rate could be as high as 80%. Therefore, the study design of this single arm, non-randomized, pilot study assessed the efficacy and safety profile of a triple therapy combination with palonosetron, dexamethasone, and promethazine to prevent PONV in patients undergoing craniotomies under general anesthesia.MethodsThe research protocol was approved by the institutional review board and 40 subjects were provided written informed consent. At induction of anesthesia, a triple therapy of palonosetron 0.075 mg IV, dexamethasone 10 mg IV, and promethazine 25 mg IV was given as PONV prophylaxis. After surgery, subjects were transferred to the surgical intensive care unit or post anesthesia care unit as clinically indicated. Ondansetron 4 mg IV was administered as primary rescue medication to subjects with PONV symptoms. PONV was assessed and collected every 24 h for 5 days via direct interview and/or medical charts review.ResultsThe overall incidence of PONV during the first 24 h after surgery was 30% (n = 12). The incidence of nausea and emesis 24 h after surgery was 30% (n = 12) and 7.5% (n = 3), respectively. The mean time to first emetic episode, first rescue, and first significant nausea was 31.3 (±33.6), 15.1 (±25.8), and 21.1 (±25.4) hours, respectively. The overall incidence of nausea and vomiting after 24–120 h period after surgery was 30% (n = 12). The percentage of subjects without emesis episodes over 24–120 h postoperatively was 70% (n = 28). No subjects presented a prolonged QTc interval ≥500 ms before and/or after surgery.ConclusionOur data demonstrated that this triple therapy regimen may be an adequate alternative regimen for the treatment of PONV in patients undergoing neurological surgery under general anesthesia. More studies with a control group should be performed to demonstrate the efficacy of this regimen and that palonosetron is a low risk for QTc prolongation.ClinicalTrials.gov IdentifierNCT02635828 ().

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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The Effect of a Combination Treatment Using Palonosetron, Promethazine, and Dexamethasone on the Prophylaxis of Postoperative Nausea and Vomiting and QTc Interval Duration in Patients Undergoing Craniotomy under General Anesthesia: A Pilot Study

et al. 2016

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“…ondansetron for CINV prevention has been restricted to a maximum of 16 mg per dose [8]. The effect of palonosetron (PALO) on ECG measures has been studied in both healthy volunteers [9] and cancer patients [10][11][12]. Two of the trials found significant differences in heart rate (HR) after administration of PALO compared with baseline [10,12], but no HRcorrected cardiac measures significantly differed.…”

Section: Introductionmentioning

confidence: 99%

Safety of an Oral Fixed Combination of Netupitant and Palonosetron (NEPA): Pooled Data From the Phase II/III Clinical Program

et al. 2016

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Background. Standard prophylaxis for chemotherapy-induced nausea and vomiting (CINV) with highly emetogenic and anthracycline-cyclophosphamide-based chemotherapy includes a 5-hydroxytryptamine-3 receptor antagonist, a neurokinin-1 receptor antagonist (NK 1 RA), and corticosteroid therapy. NEPA is a fixed combination of netupitant and palonosetron. The primary objective of this analysis was to document the safety profile, including cardiac safety, of NEPA 1 dexamethasone in comparison with current therapies across all phase II/III trials. Materials and Methods. This pooled analysis was based on data from 3,280 patients in 4 randomized, double-blind clinical trials. Patients were categorized into 1 of 3 pooled groups on the basis of actual treatment received: NEPA 1 dexamethasone, palonosetron 1 dexamethasone, and aprepitant 1 ondansetron/palonosetron 1 dexamethasone. Safety was assessed by number and frequency of adverse events (AEs) and changes from baseline electrocardiogram measures.

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“…As seen in several large randomised phase three trials, palonosetron is equally effective when compared to ondansetron [38], granisetron [39] and dolasetron [40] in preventing acute emesis and more effective in preventing delayed emesis. Importantly, QTc prolongation has not been described with palonosetron [41,42]. Updated antiemetic guidelines from the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) recommend palonosetron as the preferred 5HT3 antagonist for patients who receive moderately emetogenic chemotherapy [43][44][45].…”

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confidence: 99%

Chemotherapy Induced Nausea and Vomiting: Fear Makes the Wolf Bigger than He is

Sharma¹,

Bajpai²

2017

J Carcinog Mutagen

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Chemotherapy induced nausea and vomiting (CINV) is one of the most feared and severe side effects of cancer treatment. It is broadly categorised as anticipatory (a conditioned reflex, due to past experience, generally triggered by same stimuli), acute (within 24 hours of chemotherapy administration), delayed (after 24 hours and lasting up to 7 days of chemotherapy), breakthrough (inspite of primary prophylaxis for CINV), and refractory (unresponsive to prophylactic and breakthrough medications). The chemotherapeutic regimens are having varying potential (high, moderate, low, or minimal) for CINV. Incidence and timing of CINV depends upon the emetogenic potential of chemotherapy and also patient factors. This perspective highlights the underlying mechanism of CINV, state of the art therapeutic options and nuances in the field to better control this dreaded complication and in turn enhance the quality of life of these patients.

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Effect of single doses of IV palonosetron, up to 2.25 mg, on the QTc interval duration: a double-blind, randomized, parallel group study in healthy volunteers

Cited by 17 publications

References 30 publications

The Effect of a Combination Treatment Using Palonosetron, Promethazine, and Dexamethasone on the Prophylaxis of Postoperative Nausea and Vomiting and QTc Interval Duration in Patients Undergoing Craniotomy under General Anesthesia: A Pilot Study

The Effect of a Combination Treatment Using Palonosetron, Promethazine, and Dexamethasone on the Prophylaxis of Postoperative Nausea and Vomiting and QTc Interval Duration in Patients Undergoing Craniotomy under General Anesthesia: A Pilot Study

Safety of an Oral Fixed Combination of Netupitant and Palonosetron (NEPA): Pooled Data From the Phase II/III Clinical Program

Chemotherapy Induced Nausea and Vomiting: Fear Makes the Wolf Bigger than He is

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