Oral Granisetron Research Articles

Transdermal versus oral granisetron in controlling chemotherapy-induced nausea and vomiting: a meta-analysis.

To compare the efficacy of transdermal granisetron versus oral granisetron in controlling chemotherapy-induced nausea and vomiting (CINV) in patients with cancer METHODS: Data sources were CENTRAL, MEDLINE, EMBASE, Clinicaltrials.gov , and Google Scholar. Inclusion criteria included randomized controlled trials comparing transdermal versus oral granisetron in patients with CINV. For data extraction, two authors independently analyzed the methodological quality and extracted data. A random effects model was used to estimate the risk ratio (RR) or odds ratio (OR) with 95% confidence interval (CI). Three studies (1086 patients) were included. Oral granisetron is superior (OR 0.77; 95% CI 0.60 to 0.99) to its transdermal form in achieving complete control of CINV in patients receiving chemotherapy. As for the risk of constipation (RR 1.32; 95% CI 0.73 to 2.40) and QTc prolongation (RR 0.17; 95% CI 0.02 to 1.40) as adverse effects, no statistically significant difference was observed between the two routes. Oral granisetron is better in achieving complete control of CINV in patients receiving chemotherapy. As for the risk of constipation and QTc prolongation as adverse effects, there was no statistically significant difference between the two routes.

Impact of oral palonosetron in improving quality of life as compared to other oral 5-HT3 antagonists in delayed chemotherapy induced nausea and vomiting in patients of head and neck cancer

Background: Chemotherapy induced nausea and vomiting (CINV) remains one of the most common and debilitating complications of highly emetogenic chemotherapy (HEC). This study was undertaken to evaluate palanosetron against other 5-HT3 receptor antagonists in preventing delayed CINV with the aim of achieving complete response (CR) and improving quality of life (QoL).Methods: This was a prospective, observational study conducted on 75 histopathologically proven patients of squamous cell carcinoma of Head and Neck (H&N), who came to the Department of Radiation Oncology, Gandhi Medical College and Hamidia Hospital, Bhopal from January to December 2015. Standard protocol based chemotherapy containing highly emetogenic cisplatin based chemotherapy was administered to all the patients. For prevention of delayed chemotherapy induced nausea and vomiting all patients were prescribed oral 5-HT3 antagonists. Oral Ondansetron 4mg TDS was given to cohort 1, oral Granisetron 1 mg BD to cohort2 and oral Palanosetron 0.5mg OD was given to cohort 3. They were graded as complete response when they did not have complains of nausea and vomiting.Results: In Ondansetron, Granisetron and in Palanosetron cohort 29%, 53% and 98% patients had complete response.Conclusions: Palanosetron appears superior. Our study was conducted on handfull of patients and compared palanosetron against only two 5-HT3 receptor antagonists, so a larger study is suggested to establish the efficacy and better response of palanosetron.

Pharmacokinetics and safety of transdermal and oral granisetron in healthy Chinese subjects: An open-label, randomized, crossover study .

To examine the pharmacokinetics and safety of granisetron during transdermal delivery and oral administration to healthy Chinese male subjects. A single 34.3 mg/52 cm2 transdermal delivery patch of granisetron and the 1-mg tablet of granisetron were dosed to subjects in an open-label, randomized, crossover study. Two dosing schemes were established: scheme 1, in which the 5-day oral administration phase of the tablet (the OA phase) (twice daily every 12 hours) was conducted, followed by the 6-day transdermal delivery phase of the patch (the TD phase); and scheme 2, in which these two phases were conducted in reverse order. Plasma concentrations of granisetron were measured according to high-performance liquid chromatography, and the following pharmacokinetic parameters were determined: Cavg [AUC0-24,ss (day 5)/24 for OA and AUC24-144/120 for TD], Cmax, tmax, AUC, and T1/2. All of the subjects completed the TD phase, and 1 subject withdrew from the study due to increased alanine aminotransferase. The Cavg values for OA and TD were 2.95±1.60 ng/mL and 2.83±1.43 ng/mL, respectively. The Cmax values at steady state for OA and TD were 5.98±2.27 ng/mL and 3.91±2.23 ng/mL, respectively. The incidences of adverse events (AEs) possibly or definitely related to OA and TD were 45.83% and 37.5%, respectively. No serious AEs were found in the two dosing schemes. The Cavg values determined through TD and OA were equivalent, indicating similar drug exposures. Therefore, the granisetron patch may be an alternative formulation for oral granisetron in Chinese individuals. .

Management of chemotherapy-induced nausea and vomiting in patients receiving multiple-day highly or moderately emetogenic chemotherapy: role of transdermal granisetron.

Granisetron transdermal delivery system (GTDS) is the first 5-HT3 drug to be transdermally delivered and represents a convenient alternative to oral and intravenous antiemetics for the treatment of chemotherapy-induced nausea and vomiting. GTDS is effective and well tolerated in patients receiving multiple-day moderate-to-highly emetogenic chemotherapy. In this setting noninferiority studies showed similar efficacy when GTDS was compared with intravenous and oral granisetron and intravenous palonosetron. GTDS has shown good cardiovascular safety; however, special caution is needed in patients at risk for developing excessive QTc interval prolongation and arrhythmias. So far, GTDS has been investigated for intravenous prevention in comparison with granisetron and palonosetron; however, further prospects open the route to future clinical investigations.

Efficacy of a Transdermal Granisetron Patch in Controlling Chemotherapy-Induced Nausea and Vomiting (CINV) in Hematologic Cancer Patients

Introduction: Multiday, highly emetogenic chemotherapy regimens are commonly used in the management of hematologic malignancies. Despite progress in prophylaxis, CINV, especially during the delayed phase, can remain a significant barrier to attaining planned chemotherapy dose on time for some patients. A granisetron transdermal system (GTS) has been shown to be as effective as oral granisetron in controlling CINV across multiple tumor types. This post-hoc analysis specifically examined the efficacy and safety of GTS in patients with hematologic malignancies.Methods: A randomized, phase 3 study has been published comparing GTS (7 day application) to oral granisetron (2 mg/day) in patients receiving either moderately or highly emetogenic chemotherapy for 3-5 days. Data for this analysis were limited to patients with a primary tumor diagnosis of lymphoma (n=51), leukemia (n=27), or multiple myeloma (n=5). The rates of complete control (CC; no vomiting, mild nausea, no rescue medication) and complete response (CR; no vomiting, no rescue medication) using either GTS or oral granisetron were compared during both the acute (first 24 hours) and delayed phase (days 2 to 5) following chemotherapy. Need for rescue medication and patient assessment of response to therapy with GTS were also compared.Results: 83 hematologic cancer patients (31 GTS, 52 oral granisetron) were included. The majority of patients received a non-cisplatin regimen with corticosteroids (59 patients; 71%). Patients received chemotherapy for 3 days (37; 45%) or 4 to 5 days (46 patients; 55%). During the acute phase of CINV, the CC rate of 94% and CR rate of 94% in the GTS group were similar to rates in the overall population (94% and 95%, respectively). There was no difference in CC and CR between GTS and oral granisetron in the acute phase (P=0.90 and 0.59, respectively). In the delayed phase, GTS resulted in CC in 87% and CR in 90%; compared with CC in 77% and CR in 81% of patients given oral granisetron (P=0.26 and 0.25, respectively). The use of rescue medication over the entire study period and patient assessment of overall response to therapy were not different between arms (P=0.60 and 0.92, respectively). GTS was well tolerated; the only treatment related adverse event was one case of mild constipation.Conclusion: This retrospective analysis suggests GTS may be an appropriate option for prevention of CINV in hematologic cancer patients. A trend toward improved control in the delayed phase was observed and further investigation of a benefit in delayed CINV for hematologic malignancies may be warranted. DisclosuresFernández Velasco:ProStrakan: Employment. Wong:ProStrakan: Employment. Braccia:ProStrakan: Employment.

A randomized study of the efficacy and safety of transdermal granisetron in the control of nausea and vomiting induced by moderately emetogenic chemotherapy in Korean patients.

The granisetron transdermal system (GTS) showed non-inferior efficacy to oral granisetron to control chemotherapy-induced nausea and vomiting (CINV) during multiday chemotherapy. We compared the efficacy and safety of GTS with that of intravenous and oral granisetron in Korean patients receiving moderately emetogenic chemotherapy (MEC). A total of 276 patients were randomized into GTS (n = 139, one patch on days 1-4) or control group (n = 137, intravenous on day 1 and oral on days 2-4). The primary endpoint was the percentage of patients achieving complete response (CR) from chemotherapy initiation until 24 h after the final administration. Out of 234 patients (112 in GTS and 122 in control group) included in the per protocol analysis, 97.9 % had gastrointestinal cancer and 76.9 % received 3-day chemotherapy. The GTS showed non-inferior efficacy achieving CR in 75.0 % of the patients; 74.6 % of the patients in the control group achieved CR (95 % confidence interval -10.73 to 11.55 %). The CR rate did not change after subgroup analyses by sex, age, and chemotherapy naivety and analysis per day and overall days of treatment. The GTS group showed sustained CR from day 1 to day 4. Patients' satisfaction, assessed using Functional Living Index-Emesis (FLI-E), showed no difference. Both treatments were well tolerated and safe. The GTS showed non-inferior efficacy to intravenous and oral granisetron. The safety, tolerability, and FLI-E scores of the GTS were comparable to those of control group. The GTS offers a convenient alternative option for relieving CINV in patients receiving MEC.

Effectiveness of granisetron in controlling pediatric gastroenteritis–related vomiting after discharge from the ED

ObjectiveThe objective of the study is to determine the efficacy of oral granisetron (a long-acting 5-HT3 receptor antagonist) in stopping vomiting subsequent to discharge from emergency department (ED), in 6-month-old to 8-year-old patients with gastroenteritis-related vomiting and dehydration, who had failed an initial trial of oral rehydration (ORT). MethodsEligible patients were offered ORT on a slowly advancing schedule. Patients who tolerated the initial ORT were discharged home. Patients who vomited were randomized to receive either 40 μg/kg of granisetron or placebo, and ORT was resumed. Patients who tolerated the postrandomization ORT were discharged home with another dose of the study drug. Parents were contacted by telephone every 24 hours until complete resolution of symptoms. The primary outcome was the proportion of patients with vomiting at 24 hours. ResultsOf the 900 eligible patients, 537 (60%) tolerated the initial ORT and were discharged home. Of the patients who vomited during the initial ORT, 165 were included in the final study sample (placebo, n = 82; granisetron, n = 83). There was no statistically significant difference in the proportion of patients with vomiting at 24 hours (granisetron, n = 38; placebo, n = 45; odds ratio, 0.64; 95% confidence interval, 0.34-1.19; P = .16). A similar trend in the proportion of patients with vomiting was noted for the entire follow-up period (granisetron, n = 43; placebo, n = 47; odds ratio, 0.73; P = .33; 95% confidence interval, 0.39-1.36). ConclusionGranisetron was not effective in controlling gastroenteritis-related vomiting subsequent to discharge from ED. It did not change the expected course of the illness.

Randomized Double Blind Trial to Compare the Efficacy of Granisetron And Ondansetron in Controlling Emesis in Children with Acute Lymphoblastic Leukemia

Introduction: Nausea and vomiting are the most important side effects of cytotoxic chemotherapy and it is reported by the patients who receive chemotherapy for malignancies. Ondansetron and granisetron (5 HT3 receptor antagonists) are effective compounds with relatively less toxicity to prevent nausea and vomiting induced by high and moderate emitogenic chemotherapy. Objective: This study was carried out to evaluate the efficacy of granisetron and ondansetron preventing chemotherapy induced nausea and vomiting (CINV). Methods: In this randomized double blind trial 60 children (4-11 years) with acute lymphoblastic leukemia (ALL) who received high dose methotrexate (HDMTX-2.5gm/ m2). Each patients received either ondansetron 4 mg or granisetron 1mg (n=30) orally half an hour before HDMTX. Nausea and vomiting were assessed based on ‘’modified Morrow Assessment of Nausea and Emesis’’ (MANE) scale for application to the children. Results: Complete response of granisetron significantly differed from ondansetron from day 2-4 (delayed emesis) (p=0.028).Complete response to acute CINV were 90% in granisetron and 70% in ondansetron treated children (p=0.053), which was not statistically significant. No Child of granisetron group required additional dose but 16.7% children of ondanseton group required additional dose on the first day (p=0.05). Episodes of nausea found in ondansetron treated children 36.7% and in granisetron group 3.3% on day four (p=0.001). Maximum episodes of vomiting found in ondansetron treated children 33.3% and minimum episodes in granisetron group 3.3% on day 2 (p=0.003). In few cases adverse effects (headache, constipation, abdominal pain, loose motion and decreased appetite) were observed in both group of patients (p=0.999). Only in 3.3% cases anticipatory nausea and vomiting had observed. Conclusion: In conclusion, single dose oral granisetron (1mg) is superior to oral ondansetron (4mg) preventing chemotherapy induced emesis in children with ALL receiving HDMTX therapy. DOI: http://dx.doi.org/10.3329/bjch.v36i3.14272 BANGLADESH J CHILD HEALTH 2012; VOL 36 (3) : 115-121

THIS ARTICLE HAS BEEN RETRACTED: Preoperative oral granisetron prevents postoperative nausea and vomiting

Acta Anaesthesiologica ScandinavicaVolume 57, Issue 4 p. 536-536 NOTICE OF RETRACTIONFree Access THIS ARTICLE HAS BEEN RETRACTED: Preoperative oral granisetron prevents postoperative nausea and vomiting This article retracts the following: Preoperative oral granisetron prevents postoperative nausea and vomiting Y. Fujii, H. Tanaka, H. Toyooka, Volume 42Issue 6Acta Anaesthesiologica Scandinavica pages: 653-657 First Published online: December 31, 2008 First published: 11 March 2013 https://doi.org/10.1111/aas.12061AboutSectionsPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Retraction. The following article ‘Preoperative oral granisetron prevents postoperative nausea and vomiting.’ Fujii Y, Tanaka H, Toyooka H. Acta Anaesthesiol Scand. 1998 JUL: 42 (6):653–7. doi: 10.1111/j.1399-6576.1998.tb05297.x. (published online December 31 2008) has been retracted at the request of the Editor-in-Chief Lars S. Rasmussen by agreement with Blackwell Publishing Ltd. This is the result of: (i) overwhelming evidence of fabrication in Dr Fujii's studies, related to the fact that the distributions of many variables reported in these studies could not have occurred by chance;1,2 and (ii) the inability of Dr Fujii's institution (Toride Kyodo General Hospital) to attest to the integrity of the study and/or its data, or ethical approval, conducted under its auspices, as set out in the Joint Editors-in-Chief Request for Determination of April 9, 2012.3 References 1 Carlisle JB. The analysis of 168 randomised controlled trials to test data integrity. Anaesthesia 2012; 67: 521– 537. 2 Kranke P, Apfel CC, Roewer N, Fujii Y. Reported data on granisetron and postoperative nausea and vomiting by Fujii et al. are incredibly nice! Anesth Analg. 2000; 90: 1004– 1007. 3 Joint Editors-in-Chief letter. http://onlinelibrary.wiley.com/store/10.1111/(ISSN)1365-2044/asset/homepages/Fujii_Joint_EiC_letter_to_institutions_April_9.pdf?v=1&s=314f66742edb10d5399ab2e31712de1aaefc15f8. 4 Fujii Y, Tanaka H, Toyooka H. Preoperative oral granisetron prevents postoperative nausea and vomiting. Acta Anaesthesiol Scand 1998; 42: 653– 657. doi: 10.1111/j.1399-6576.1998.tb05297.x. Volume57, Issue4April 2013Pages 536-536 ReferencesRelatedInformation

A randomized double-blind placebo-controlled cross-over trial of the impact on quality of life of continuing dexamethasone beyond 24 h following adjuvant chemotherapy for breast cancer

Uncertainty remains about the optimal anti-emetic regimen for control of delayed nausea and vomiting after adjuvant chemotherapy for breast cancer. Many patients receive dexamethasone but complain of insomnia, anxiety/agitation, and indigestion. The aim was to determine if patients receiving chemotherapy for breast cancer prefer treatment with dexamethasone or placebo for prophylaxis against delayed nausea and vomiting, and to compare quality of life (QOL) between the two treatments. In this randomized, double-blind, cross-over trial, we compared oral dexamethasone (4mg twice daily for 2days) versus placebo for chemotherapy-naïve patients with breast cancer. All patients received intravenous granisetron and dexamethasone pre-chemotherapy and oral granisetron on day 2. Primary endpoints were: (i) patient preference; (ii) difference between cycles in change of QOL from days 1 to 8. Median age of the 94 women was 51years (range 27-76): 79 received fluorouracil/epirubicin/cyclophosphamide and 15 received doxorubicin/cyclophosphamide. Thirteen withdrew pre-cycle 2 with no differences between arms. Of 80 patients stating a preference, 31 preferred placebo (39%, 95% CI: 28-50%) and 37 (46%, 95% CI: 35-58%) preferred dexamethasone; 12 had no preference. There were no differences in intensity of vomiting, nausea, or time to onset of vomiting. There was greater decrease in global QOL (p=0.06) when patients received dexamethasone. No other symptom/QOL domains differed significantly. In conclusion, no significant difference was found in patient preference, QOL, or symptoms regardless of whether dexamethasone or placebo was used after adjuvant chemotherapy.

Transdermal Granisetron: A Guide to Its Use in Preventing Nausea and Vomiting Induced by Chemotherapy

Transdermal granisetron (Sancuso®) is effective in the prevention of nausea and vomiting in patients with cancer who are receiving moderately or highly emetogenic chemotherapy for 3-5 days. Transdermal granisetron is noninferior to oral granisetron in this indication, and is generally well tolerated in this indication. Thus, transdermal granisetron provides a convenient option for the prevention of chemotherapy-induced nausea and vomiting, with the potential to improve patient compliance.

Use of transdermal and intravenous granisetron and the ability of the Hesketh score to assess nausea and vomiting induced by multiday chemotherapy

PurposeHesketh scores define emetogenicity of single-agent and multiagent single-day chemotherapy. This analysis determined the emetogenicity of multiagent, multiday chemotherapy and the Granisetron Transdermal System (GTDS; Sancuso®).MethodsThis was a retrospective analysis of a multicenter, randomized, double-blind, phase III noninferiority trial of GTDS versus oral granisetron in patients receiving 3 days of multiagent moderately or highly emetogenic chemotherapy, regardless of granisetron formulation. Emesis was defined as vomiting/retching or the use of rescue medication. Logistic regression and classification trees were used to determine the optimal combination of Hesketh scores over the multiagent, multiday regimens for the prediction of emesis.ResultsOf 393 patients, 272 (69.2%) were chemotherapy naïve. The most common types of cancer were lung (30.5%) and gynecologic (21.9%). The most common chemotherapeutic regimen (in 14.2% of patients) was cisplatin plus etoposide on days 1–3. The best binary emesis predictor was day 1 Hesketh score. Patients with a day 1 Hesketh score of 5 had the highest rate of emesis (62.5%) versus patients with a score < 5 (31.7%). For patients with day 1 Hesketh score < 5, only 14.3% of those receiving only one drug on day 1 experienced emesis.ConclusionHesketh emetogenicity scores of individual agents are applicable to multiday, multiagent chemotherapeutic regimens in patients receiving antiemetics.

Notice of Retraction: “Prophylaxis With Oral Granisetron for the Prevention of Nausea and Vomiting After Laparoscopic Cholecystectomy (Arch Surg. 2001;136[1]:101-104)

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Safety and efficacy of granisetron transdermal delivery system versus oral granisetron for prevention of chemotherapy induced nausea and vomiting in patients treated for gynecologic malignancies

Objective: Granisetron transdermal delivery system (GTDS) offers a convenient alternative to oral and intravenous routes of administration for multiple day chemotherapy regimens. The purpose of this analysis is to determine the safety and efficacy of GTDS compared to oral granisetron the control of chemotherapy induced nausea and vomiting (CINV) in patients treated for gynecologic malignancy.

429 Granisetron in the Management of Gastroenteritis-Related Vomiting in a Pediatric Emeregncy Department: A Randomized Placebo-Controlled Clinical Trial

429 Granisetron in the Management of Gastroenteritis-Related Vomiting in a Pediatric Emeregncy Department: A Randomized Placebo-Controlled Clinical Trial

Cardiac safety of a granisetron transdermal system in the treatment of chemotherapy-induced nausea and vomiting.

e19601 Background: Granisetron, a 5-HT3 antagonist, is widely used as an antiemetic. However, 5-HT3 antagonists may have cardiac effects, as shown by the withdrawal of IV dolesetron for treatment of chemotherapy-induced nausea and vomiting (CINV) in the US owing to risk of cardiac effects. Such effects are a concern, as chemotherapy and radiotherapy can cause acute dysrhythmias and longer-term cardiac damage. Granisetron Transdermal System (GTDS, Sancuso) is approved in the US for prevention of CINV in patients receiving up to 5 days of moderately or highly emetogenic (MEC, HEC) consecutive chemotherapy. GTDS is applied 24–48 hours prior to chemotherapy and can be left in place up to 7 days. Because of the novel delivery and altered pharmacokinetic profile of granisetron in the GTDS compared with IV or oral delivery, cardiac safety was investigated in a phase III clinical trial and a phase I QTc cardiac safety study. Methods: In a randomized, double-blind, phase III trial of GTDS vs oral granisetron in multiday MEC and HEC regimens, patients had sequential 12-lead ECG readings at baseline, at start of chemotherapy (coinciding with the estimated granisetron maximum plasma concentration [Cmax]), and at 120 hours post treatment. In a blinded placebo-controlled phase I QTc study, healthy subjects received GTDS, placebo, or active control. The primary end point was time-matched, placebo-corrected change from baseline in QTc based on the Fridericia correction (ddQTcF), allowing exclusion ≥10 ms increases at the 95% CI level, tested at 3 or more time points around the granisetron Cmax. Results: In the phase III trial, there were no clinically relevant changes in repolarization intervals, ECG morphology, or heart rate in the GTDS group (n=273). In the phase I QTc study, mixed-effects modeling showed a maximum ddQTcF in the GTDS group (n=60) of 1.9 ms on day 3 and 2.5 ms on day 5, excluding any change ≥10 ms at the 95% CI level. Conclusions: In a phase III trial in patients receiving chemotherapy and GTDS, no cardiac safety issues emerged. This finding was supported by a phase I QTc study of GTDS in healthy subjects that showed no significant QTc prolongation at standard regulatory and clinical thresholds.

A randomized, double-blind, placebo-controlled cross over trial of the effect on quality of life (QOL) of continuing dexamethasone beyond 24 hours following moderately emetogenic chemotherapy in women with breast cancer.

9020 Background: Dexamethasone (D) improves acute nausea and vomiting when given pre chemotherapy (CTh), and continued D improves emesis after highly emetogenic CTh. There is lack of consensus about the optimal antiemetic regimen for delayed control after moderately emetogenic CTh. Many patients complain of symptoms while on D that may impact on QOL. Methods: A randomized double-blind cross-over trial compared D versus placebo (P) for delayed emesis in CTh-naïve women with breast cancer treated with moderately emetogenic CTh. All patients received IV granisetron and IV D pre-CTh and oral granisetron on day 2. Patients were randomized to oral D (4mg bid) or P for 48 hours, and changed to the alternative treatment for cycle 2. Primary endpoints were: (i) patient preference; (ii) difference between cycles in change in QOL (EORTC-QLQ-C30) from day 1 to 8. Secondary endpoints were emesis (Functional Living Index-Emesis; patient diaries) and the Dexamethasone Symptom Questionnaire. Results: Mean age of the 94 women recruited was 51yrs (range 27-76); 15 received AC and 79 FEC CTh. Thirteen women withdrew pre-cycle 2 with no difference in rates or reasons for withdrawal between arms. Thirty-one women preferred P and 37 preferred D (54% of those with a stated preference; 95% CI: 42-67%); 12 stated no preference. Of those preferring D, 54% rated it ‘much better’, compared with 39% for P. Patients had increased symptoms and decreased QOL from D1 to D8 in both cycles. There was greater decrease in global QOL (p=.06) and greater increase in pain (p=.04) when patients received D. No other symptom/QOL domains were significantly different. A non-significant decrease in vomiting intensity and delay in onset of vomiting was observed when receiving D, with no difference in nausea. Conclusions: No difference was found in patient preference, QOL or symptoms regardless of whether D or P was used for delayed emesis after moderately emetogenic CTh. We suggest continued D be omitted from initial antiemetic regimens for moderately emetogenic CTh, and offered selectively to patients with poor initial control of delayed nausea and vomiting.

Efficacy and tolerability of transdermal granisetron for the control of chemotherapy-induced nausea and vomiting associated with moderately and highly emetogenic multi-day chemotherapy: a randomized, double-blind, phase III study

PurposeA novel transdermal formulation of granisetron (the granisetron transdermal delivery system (GTDS)) has been developed to deliver granisetron continuously over 7 days. This double-blind, phase III, non-inferiority study compared the efficacy and tolerability of the GTDS to daily oral granisetron for the control of chemotherapy-induced nausea and vomiting (CINV).Patients and methodsSix hundred forty-one patients were randomized to oral (2 mg/day, 3–5 days) or transdermal granisetron (one GTDS patch, 7 days), before receiving multi-day chemotherapy. The primary endpoint was complete control of CINV (no vomiting/retching, no more than mild nausea, no rescue medication) from chemotherapy initiation until 24 h after final administration. The prespecified non-inferiority margin was 15%.ResultsFive hundred eighty-two patients were included in the per protocol analysis. The GTDS displayed non-inferiority to oral granisetron: complete control was achieved by 60% of patients in the GTDS group, and 65% in the oral granisetron group (treatment difference, −5%; 95% confidence interval, −13–3). Both treatments were well tolerated, the most common adverse event being constipation.ConclusionsThe GTDS provides effective, well-tolerated control of CINV associated with moderately or highly emetogenic multi-day chemotherapy. It offers a convenient alternative route for delivering granisetron for up to 7 days that is as effective as oral granisetron.Electronic supplementary materialThe online version of this article (doi:10.1007/s00520-010-0990-y) contains supplementary material, which is available to authorized users.

Comparison of Ondansetron and Granisetron for prevention of PONV following elective LUCS

The aim of the study was to compare the antiemetic effects of oral ondansetron (8mg) and granisectron (2mg) for prevention of PONV following elective caesarean section. Ninety parturients scheduled for elective caesarean section under spinal anaesthesia were randomly allocated into three groups. Group A (n=30) were received vitamin tab, group B (n=30) parturients were received oral ondansectron (8mg) &amp; group C (n=30) parturients were received oral granisetron (2mg). Anesthetic procedure was common to all groups. Emetic episodes in early postoperative period (1st 24 hrs.) were recorded and compared in different study groups. Emetic episodes were observed in six parturients (20%) in group A (control), 3 parturients in group B (3%) and 3 parturients in group C (3%). So to conclude, minimal emetic episodes were observed in early postoperative period in parturients who had received ondensetron or granisetron than the control group. Keywords: LUCS, PONV, Ondansetron, and Granisetron. Journal of BSA, Vol. 20, No. 2, July 2007 p.61-65

Use of granisetron transdermal system in the prevention of chemotherapy-induced nausea and vomiting: a review

Use of granisetron transdermal system in the prevention of chemotherapy-induced nausea and vomiting: a review Albert TucaPalliative Care Hospital Team, Palliative Care Department, Institut Catal&agrave; d&rsquo;Oncologia, L&rsquo;Hospitalet de Llobregat, Barcelona, SpainAbstract: Until now only intravenous and oral formulations of 5HT3 receptor antagonists have been available. Recently a new formulation of a 5HT3 receptor antagonist, transdermal granisetron, has been developed, and approved by the FDA. Three phase I studies to evaluate its pharmacokinetic profile have shown that granisetron administered by a transdermal delivery system is absorbed by passive diffusion and maximal concentration is reached 48 hours after patch application. The patch of 52 cm2, which contains 34.3 mg of granisetron, releases 3.3 mg of the drug every day and maintains a stable average plasma concentration of 2.2 ng/mL over 6 days, similar to levels obtained with 2 mg of oral granisetron, administered every day during the same period of time. Two randomized as yet unpublished clinical trials (phase II/III) have been conducted to evaluate the antiemetic efficacy of transdermal granisetron in chemotherapy-induced nausea and vomiting, in patients receiving moderately and highly emetogenic chemotherapy, compared with 2 mg of oral granisetron. More than 800 cancer patients were included in the trials. The rate of complete control of acute emesis was 49% for the phase II trial and 60% for the phase III trial. Neither trial showed a statistically significant difference between transdermal and oral granisetron. The control of delayed emesis was observed in 46% of patients, and there were no statistically significant differences between transdermal and oral granisetron. The most common adverse effects in both trials were constipation (&lt;7%) and headache (&lt;1%); there were no statistically significant differences between transdermal and oral granisetron. These data show that transdermal granisetron is effective and safe in controlling acute emesis induced by chemotherapy with both moderate and high emetogenic potential. Efficacy and safety of transdermal granisetron are fully comparable with that of oral granisetron. More clinical trials using regimens of 2 or 3 drugs, including dexamethasone and/or aprepitant, are needed to confirm the place of transdermal granisetron in the control of chemotherapy-induced nausea and vomiting.Keywords: cancer chemotherapy induced nausea and vomiting, selective antagonists of 5HT3 receptors, granisetron, transdemal delivery system