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At least 19 recordsLinked to original sources
PubMed1996

Are more antiemetic trials with a placebo necessary? Report of patient data from randomized trials of placebo antiemetics with cisplatin.

BACKGROUND: Because of the predictability of significant emesis after its use, cisplatin serves as the standard emetic stimulus for trials of antiemetic drugs. To define better the incidence, severity, and pattern of emesis that follows cisplatin, facilitate the testing of new agents, and obviate the need for further placebo-controlled trials for this indication, individual patient data were compiled from completed studies with placebo antiemetics and cisplatin. METHODS: The time and number of emetic episodes during the 24 hours after cisplatin were obtained for 48 patients given a placebo antiemetic. Each was treated as part of a randomized, double-blind trial reported between 1981 and 1990. Emesis after antiemetic "rescue" therapy was also assessed. RESULTS: Emesis occurred in 47 of 48 patients (98% observed rate, 95% confidence interval, 89-99%). The median number of emetic episodes during the 24 hours after cisplatin was 6. Emesis continued after rescue in 77% of patients. CONCLUSIONS: Cisplatin caused severe emesis that persisted despite rescue in placebo-treated patients. Using the data presented, any therapy preventing acute emesis in 8 or more of the 48 individuals receiving cisplatin > 50 mg/m2 was an active antiemetic (P = 0.05). The four trials discussed here documented the antiemetic effectiveness of granisetron, metoclopramide, and ondansetron. The placebo-treated patients studied can serve as a control group for testing new therapies. Because of the certainty of severe emesis after cisplatin, and the availability both of these data and several proven drugs for this condition, prospective comparisons of antiemetics should employ active control medications.

Adult↗
PubMed2000

Antiemetic efficacy of combination therapy with granisetron plus prednisolone plus the dopamine D2 antagonist metopimazine during multiple cycles of moderately emetogenic chemotherapy in patients refractory to previous antiemetic therapy.

Effective antiemetic treatment of patients who have previously experienced chemotherapy-induced nausea and vomiting is difficult. The aim of this study was to evaluate the antiemetic efficacy of a single intravenous dose of granisetron plus a 3-day oral treatment with prednisolone 25 mg once a day plus metopimazine 30 mg four times a day in patients refractory to previous antiemetic treatment with granisetron or with prednisolone plus metopimazine. The study population was made up of 25 consecutive women with stage I or II breast cancer, who were treated with multiple cycles of adjuvant cyclophosphamide, fluorouracil plus methotrexate or cyclophosphamide, epirubicin plus fluorouracil given i.v. every 3 weeks. Patients received the three-drug combination of antiemetics during a total of 113 cycles of chemotherapy. No emetic episodes were reported in 88.9% cycles on day 1, in 94.7% cycles on days 2 through 5 and in 85.8% cycles on days 1 through 5 after chemotherapy. No nausea was reported in 43.4% cycles on day 1, in 49.6% cycles on days 2 through 5 and in 34.5% cycles on days 1 through 5. Nineteen patients (76.0%) completed the scheduled nine cycles of chemotherapy, 1 being withdrawn because of > or =5 emetic episodes and 5, because they were not satisfied with the antiemetic treatment. The treatment was well tolerated. In conclusion, granisetron plus prednisolone plus metopimazine is a highly effective antiemetic treatment in patients receiving moderately emetogenic chemotherapy refractory to antiemetic therapy with granisetron or prednisolone plus metopimazine.

Adult↗
PubMed1998

Assuring the optimal use of serotonin antagonist antiemetics: the process for development and implementation of institutional antiemetic guidelines at Memorial Sloan-Kettering Cancer Center.

PURPOSE: The need to foster the appropriate and cost-effective use of serotonin-antagonist antiemetic drugs spurred the creation of guidelines. The process by which institution-wide guidelines at Sloan-Kettering were developed, implemented, assessed, and modified is described. METHODS: A multidisciplinary group working with disease-specific management teams assigned the emetic potential of chemotherapy programs to one of five categories. Antiemetic regimens, including a specified dose and schedule of a serotonin-antagonist and dexamethasone, were assigned to each emetic category. The information was collated by disease site and chemotherapy program into hospital-wide antiemetic regimen recommendations. Quality assessment was conducted initially and repeated each time the guidelines were modified. RESULTS: Patient surveys demonstrated a high level of satisfaction with emetic control, which was similar to reported results. Data from the latest survey showed zero emetic episodes in 93% and 87% of participants given moderate and highly emetogenic chemotherapy, respectively. Compliance with the guidelines, initially in 73%, has been improved using a standardized chemotherapy order "check box" labeled, "Antiemetics as per Guidelines." Antiemetic drug expenditures decreased from a projected $2.8 million to $1.3 million annually. CONCLUSION: The guidelines became an educational tool that ensured the delivery of optimal antiemetic therapy chosen by professionals with the greatest knowledge of both the particular chemotherapy regimen and cancer site. Implementation of the guidelines resulted in substantial savings while treating more patients. The guidelines were easily modified as new chemotherapeutic agents and antiemetic drugs became available.

Antiemetics↗
PubMed1992

Prevention of chemotherapy-induced nausea and emesis in patients responding poorly to previous antiemetic therapy. Comparing tropisetron with optimised standard antiemetic therapy.

In a multicentre trial, 78 patients with a variety of malignancies, who had experienced insufficient control of emesis (greater than or equal to 3 episodes within 24 hours) while receiving standard antiemetics during previous chemotherapy, were randomly assigned to receive tropisetron 5mg once daily for 5 days or conventional antiemetic drugs. No attempt was made to standardise the conventional antiemetic treatment, which was given according to the usual practice of the participating institutions. Emesis was evaluated by counting emetic episodes and nausea by asking the patients to record on a diary chart the duration and severity of the nausea. Emesis was much better controlled with tropisetron than with standard drugs, complete control during the first 24 hours being achieved in 42% and 8% of patients, respectively, (p less than 0.001). Nausea was of significantly shorter duration (6.9 vs 10.3 hours; p less than 0.01) and was less severe (p less than 0.005) in the tropisetron group. The patients' overall assessment of treatment outcome was markedly better for tropisetron than for the standard antiemetic therapy. The superior efficacy of tropisetron was especially marked during the first 24 hours. For delayed nausea, no significant difference between treatments was seen. No serious adverse effects were observed.

Adult↗
PubMed1998

Transferability to clinical practice of the results of controlled clinical trials: the case of antiemetic prophylactic treatment for cancer chemotherapy-induced nausea and vomiting. Italian Group for Antiemetic Research.

BACKGROUND: There is convincing evidence from randomized clinical trials that the use of 5-HT3 antagonists has brought about a substantial improvement in the control of chemotherapy-induced nausea and vomiting. However, no data exist to indicate how this new research evidence can be applied to the individual patient. PATIENTS AND METHODS: We carried out a prospective, observational study on the use and effectiveness of antiemetic drugs in patients undergoing cancer chemotherapy in 33 Italian oncology departments. RESULTS: A total of 1,956 consecutive patients entered the study; 1,238 of them underwent a one-day chemotherapy and 718 a chemotherapy fractionated over several consecutive days. The 5-HT3 antagonists, used either alone or in combination with a corticosteroid, have almost completely supplanted all other types of antiemetic regimens for preventing cancer chemotherapy-induced emesis. In fact, 80% of patients, irrespective of whether their emesis was acute or delayed, or of the emetogenic potential of the cancer chemotherapy they received, have been treated with these compounds. However, the practice of participating oncologists with respect to prescriptions has been far from consistent with the evidence provided by randomized controlled trials. Both overtreatment and undertreatment have occurred in many patients, creating unjustified costs and placing the patients at greater risk for emesis. However, when antiemetics are properly used their effectiveness is similar to that seen in randomized controlled trials. CONCLUSIONS: Powerful barriers exist between the evidence provided by sound research and clinical practice, and this issue hampers progress toward the optimal use of antiemetic drugs.

Adult↗
PubMedDate not supplied

Prevention of nausea and vomiting (N&V) in cancer patients receiving high-dose cisplatin. Assessment of the potential antiemetic activity of transdermal fentanyl (TTS-F) compared to standard antiemetic treatment in acute and delayed N&V: first clinical report.

UNLABELLED: A single-institution, prospective, open crossover study was performed to compare the effectiveness and tolerability of transdermal fentanyl (TTS-F) vs intravenous (i.v.) ondansetron (OND), both combined with i.v. DEX, in the prevention of acute nausea and vomiting (N&V), and TTS-F vs metoclopramide (M), both combined with intramuscular (i.m.) DEX, in the prevention of delayed N&V in patients with advanced stage head and neck squamous cell carcinoma receiving high-dose (> or = 100 mg/m2) cisplatin. This is the first report on the clinical use of TTS-F in this setting. PATIENTS AND METHODS: All patients were adequately informed of the study characteristics and gave their written informed consent before study entry. The antiemetic treatment for acute N&V consisted of A) OND 8 mg plus DEX 20 mg (i.v.) or B) TTS-F 75 micrograms/h plus DEX 20 mg i.v. For prevention of delayed N&V, patients receiving TTS-F for acute N&V were given TTS-F at the same dosage (75 micrograms/h) on days 2-5, whereas patients receiving OND for acute N&V were treated with M 20 mg orally every 6 h on days 2-5, starting 24 h after CDDP. All patients received DEX 8 mg i.m. every 12 h on days 2 and 3, 4 mg i.m. every 12 h on days 4 and 5, starting 24 h after CDDP. From November 1997 to April 1998, 15 consecutive patients entered the study and were assigned to one of the two alternative treatments for acute N&V. All of them were evaluable. Twelve patients were evaluable for delayed N&V. Seven patients were assigned to Group 1 starting with treatment A (OND + DEX) and 8 patients were assigned to Group 2 starting with treatment B (TTS-F + DEX). In the prevention of acute N&V, the overall efficacy of OND + DEX was statistically significantly higher than that of TTS-F + DEX in achieving Complete Response (CR) and Major Efficacy (ME = CR + Major Response, MaR). As for delayed N&V, the overall efficacy of M + DEX, both in achieving CR and ME, although higher, was statistically not significantly different from that of TTS-F + DEX. Unfortunately, due to the small number of patients included in the study, the sophisticated criteria for evaluating response in antiemetic research, such as the persistence of efficacy, the response after crossing-over, did not make it possible for us to draw additional conclusions, although the trend was in favor of "standard" treatments, particularly in acute N&V. The 'response to treatment A (OND + DEX) in the prevention of acute N&V was in the same range as the response to treatment A (M + DEX) for delayed N&V. The response to treatment B (TTS-F) for acute N&V was lower than the response to the same treatment for delayed N&V. The TTS-F treatment was well-tolerated with no significant side-effects including the well-known opioid-related symptoms. Our study confirms that the currently available standard antiemetic treatments both for acute and delayed N&V must be considered by far the most effective ones for clinical use.

Administration, Cutaneous↗
PubMed2006

[Successful antiemetic treatment of TSUMURA Rikkunshi-to Extract Granules for ethical use in addition to other antiemetic agents in neoadjuvant chemotherapy for an advanced breast cancer patient].

A 45-year-old woman who suffered from left breast cancer, 8 cm in diameter, with skin invasion and axillary lymph node involvement but no distant metastasis, underwent neoadjuvant chemotherapy. FEC100 consisting of 5-FU (500 mg/m(2)), epirubicin (100 mg/m(2)) and cyclophosphamide (500 mg/m(2)), were given intravenously for tumor reduction in connection with breast conserving surgery. Although antiemetic agents such as granisetron hydrochloride,metoclopramide and dexamethasone failed to prevent frequent emesis and loss of appetite in the first course, TSUMURA Rikkunshi-to Extract Granules (Rikkunshi-to) in addition to those antiemetic agents from the second course remarkably well controlled nausea and vomiting. Consequently, 6 courses of neoadjuvant chemotherapy were carried out successfully and brought about complete tumor remission. Rikkunshi-to was first medicated for non-ulcer dyspepsia, but now we suggest that it is possibly a good new antiemetic agent.

Antiemetics↗
PubMedDate not supplied

Antiemetic efficacy of tropisetron in patients failing previous antiemetic therapy.

Tropisetron was studied for efficacy and safety in 164 patients who were refractory to other antiemetic agents. 5 mg tropisetron was given intravenously, followed by 5 mg by mouth per day for 4 days. Complete prevention of nausea and vomiting was documented in 42% of patients on day 1 of cycle 1. Delayed nausea and vomiting were prevented in 41% in the first cycle. The antiemetic control did not decrease with subsequent cycles. Side effects ascribed to tropisetron were mild.

Antiemetics↗
PubMed1995

Persistence of efficacy of three antiemetic regimens and prognostic factors in patients undergoing moderately emetogenic chemotherapy. Italian Group for Antiemetic Research.

PURPOSE: To evaluate antiemetic efficacy and tolerability of granisetron, dexamethasone, and their combination over repeated courses of moderately emetogenic chemotherapy, and the influence of the prognostic factors on occurrence of nausea and vomiting. PATIENTS AND METHODS: Four hundred twenty-eight consecutive cancer patients were entered onto a multicenter, randomized, double-blind study to compare granisetron 3 mg intravenously, dexamethasone 8 mg intravenously, and 4 mg orally every 6 hours for four doses, or the combination of dexamethasone plus granisetron at the same doses, administered for three consecutive cycles. Occurrence of nausea, retching, and vomiting was monitored for 24 hours after chemotherapy administration by a diary card. RESULTS: Three hundred ninety-eight patients were assessable for clinical efficacy at the first cycle, 354 were assessable at the second cycle, and 322 were assessable at the third cycle of chemotherapy. Dexamethasone plus granisetron induced significantly greater complete protection from vomiting, nausea, and both nausea and vomiting than granisetron alone in all three cycles. With respect to dexamethasone alone, complete protection from vomiting was significantly greater at the first and second cycle, and complete protection from nausea and from both nausea and vomiting only at the first cycle. Complete protection did not differ significantly among the three cycles in patients receiving dexamethasone plus granisetron or dexamethasone alone, whereas it decreased significantly, at least for vomiting, in patients receiving granisetron alone. Protection obtained in the previous cycle of chemotherapy was the most important prognostic factor in the occurrence of nausea and vomiting. CONCLUSION: The combination of dexamethasone plus granisetron offers the best antiemetic protection because of its greater efficacy with respect to the other two regimens at first cycle, and because its activity is maintained in the subsequent cycles of chemotherapy.

Administration, Oral↗
PubMed2003

Reduction of emetic symptoms during cesarean delivery with antiemetics: propofol at subhypnotic dose versus traditional antiemetics.

STUDY OBJECTIVE: To evaluate the efficacy and safety of propofol (at a subhypnotic dose), droperidol, and metoclopramide in reducing emetic symptoms during cesarean delivery. DESIGN: Randomized, double-blinded, placebo-controlled study. SETTING: University hospital. PATIENTS: 100 ASA physical status I and II parturients undergoing cesarean delivery with spinal anesthesia. INTERVENTIONS: Patients received placebo (saline) followed by placebo (Intralipid(R)), placebo (saline) followed by propofol at a subhypnotic dose (1.0 mg/kg/hr), droperidol 1.25 mg followed by placebo (Intralipid(R)), or metoclopramide 10 mg followed by placebo (Intralipid(R)) intravenously (IV) immediately after clamping of the umbilical cord. MEASUREMENT AND MAIN RESULTS: The percentage of patients who were emesis-free, which was defined as experiencing no nausea, retching, or vomiting, in the intraoperative, postdelivery period was 80% with propofol, 80% with droperidol, and 78% with metoclopramide (p < 0.05), compared with placebo (40%). Severity of nausea was less inpatients who received propofol than in those who received placebo (p < 0.05), and there were no differences seen among the droperidol, metoclopramide, and placebo groups. No clinically serious adverse events as a result of the study drugs were observed in any of the groups. CONCLUSIONS: Prophylactic antiemetic efficacy of propofol at a subhypnotic dose (1.0 mg/kg/hr), droperidol 1.25 mg, and metoclopramide 10 mg is comparable in parturients undergoing cesarean delivery. Moreover, propofol at a subhypnotic dose is effective in the prevention of severe nausea.

Adult↗
PubMed1993

Difference in persistence of efficacy of two antiemetic regimens on acute emesis during cisplatin chemotherapy. The Italian Group for Antiemetic Research.

PURPOSE AND METHODS: We conducted a prospective, double-blind, multicenter study of 287 cancer patients treated for the first time with high-dose cisplatin chemotherapy who were randomly assigned to receive three consecutive cycles of the same antiemetic treatment consisting of ondansetron plus dexamethasone, or metoclopramide plus dexamethasone and diphenhydramine. RESULTS: Patients who received the ondansetron combination achieved significantly greater complete protection from vomiting, but not from nausea, in all three cycles of chemotherapy than did patients treated with metoclopramide (78.7% v 59.6%, P < .002 during the first cycle; 73.4% v 51.0%, P < .002 during the second cycle; 73.7% v 47.5%, P < .001 during the third cycle). The ability of ondansetron treatment to protect patients from vomiting during the first cycle did not change in subsequent cycles, but decreased significantly as far as complete protection from nausea and from both nausea and vomiting are concerned. With the metoclopramide combination, a significantly greater reduction of complete protection from vomiting, nausea, and both nausea and vomiting was detected. Protection obtained in previous cycles of chemotherapy was the most important prognostic factor. Adverse events were significantly less frequent with ondansetron treatment during the three cycles of chemotherapy and no cumulative toxic effects were found with either treatment. CONCLUSION: Ondansetron plus dexamethasone was significantly more efficacious and better tolerated than metoclopramide plus dexamethasone and diphenhydramine during three cycles of chemotherapy and, in contrast to the metoclopramide regimen, the efficacy of ondansetron plus dexamethasone, at least for vomiting, is maintained in subsequent cycles.

Acute Disease↗
PubMed1994

Ondansetron and dexamethasone versus standard combination antiemetic therapy. A randomized trial for the prevention of acute and delayed emesis induced by cyclophosphamide-doxorubicin chemotherapy and maintenance of antiemetic effect at subsequent courses.

The antiemetic efficacy of ondansetron and dexamethasone (Ondex) was randomly compared to that of high-dose metoclopramide, dexamethasone, and orphenadrine (Control) in the prevention of emesis induced by cyclophosphamide-doxorubicin chemotherapy in 64 chemotherapy-naive breast cancer patients. For the control of acute emesis (day 1), patients were randomized to receive either ondasetron 8 mg p.o. 1 hour prior to chemotherapy (CT) and repeated after 6 and 12 hours plus dexamethasone 20 mg i.v. 40 minutes prior to CT (Ondex) or dexamethasone 20 mg i.v. 40 minutes prior to CT, orphenadrine 40 mg i.m. 35 minutes prior to CT and metoclopramide 3 mg/kg i.v. 30 minutes prior to CT and repeated after 90 minutes followed by 40 mg p.o. every 3 hours for 4 times (Control). To control delayed emesis, patients on Ondex received ondansetron 8 mg PO t.i.d. days 2 and 3 and patients in the Control arm received metoclopramide 0.5 mg/kg p.o. q.i.d. and dexamethasone 8 mg i.m. b.i.d. days 2 and 3. Complete and major control of acute emesis was observed in 74%/94% and 44%/67% of patients treated with Ondex and Control, respectively (p < .01/p < .005). Acute nausea was absent in 38% and 34% of patients treated with Ondex and Control, respectively (p = NS). Complete and major control of delayed emesis (days 2-5) was observed in 65%/91% versus 44%/66% of patients in the Ondex and Control arms, respectively (p = NS/p < .01). In patients receiving 6 courses of FEC/FAC, control of acute emesis was significantly superior with Ondex at all treatment courses.

Acute Disease↗
PubMed1987

Antiemetic studies with traditional Chinese acupuncture. A comparison of manual needling with electrical stimulation and commonly used antiemetics.

The application of low frequency (10 Hz) electrical current for 5 minutes to an acupuncture needle placed at the P6 (Neiguan) point is as effective as manual needling in the reduction of emetic sequelae in women premedicated with nalbuphine 10 mg for a minor gynaecological operation carried out under a standard anaesthetic. Both were slightly, but not significantly, better than the antiemetic properties of cyclizine 50 mg.

Acupuncture Therapy↗
PubMed1993

[Antiemetic efficacy of granisetron in pediatric cancer treatment--(2). Comparison of granisetron and granisetron plus methylprednisolone as antiemetic prophylaxis].

A crossover clinical trial was carried out to compare the effectiveness and safety of granisetron alone (40 micrograms/kg) with that from a combination of granisetron plus methylprednisolone (MPL, 10 mg/kg) for control of emesis and vomiting induced by anticancer drugs in children with cancer. Complete control of emesis and vomiting were achieved in 95% (19/20 cases) of patients receiving the combination compared to 85% (17/20 cases) of patients receiving granisetron alone. There were no clinical toxicities or side effects in either treatment group. These data indicated that the combination of granisetron plus MPL was superior for control of emesis and vomiting in children receiving cytostatic anticancer drugs.

Adolescent↗
PubMed2005

Characterization of the use of antiemetic agents in dogs with parvoviral enteritis treated at a veterinary teaching hospital: 77 cases (1997-2000).

OBJECTIVE: To characterize the use of antiemetic agents in dogs with canine parvovirus (CPV)-associated enteritis in a veterinary teaching hospital. DESIGN: Retrospective case series. ANIMALS: 77 dogs with CPV-associated enteritis. PROCEDURE: Medical records of 560 dogs with confirmed CPV-associated enteritis that were admitted to a veterinary teaching hospital were reviewed. Exclusion criteria included vaccination against CPV infection within the preceding 2 weeks, hospitalization for < 24 hours or removal from the hospital against advice, or an incomplete record. Signalment, duration of hospitalization, and daily antiemetic administrations were assessed; WBC counts and clinical findings were used to classify dogs as having systemic inflammatory response syndrome (SIRS). RESULTS: 77 dogs were included in the study; 55 (71%) received antiemetics (53 received metoclopramide at least once). Seventy-one dogs survived, and 6 dogs died (all 6 received antiemetics). Compared with dogs that did not receive antiemetics, duration of hospitalization was significantly longer for antiemetic-treated dogs. Daily values of rectal temperature and heart and respiratory rates did not predict administration of antiemetics or duration of hospitalization; however, compared with survivors, SIRS developed more frequently among nonsurvivors. Assessment of emetic events recorded hourly for 17 dogs indicated that antiemetic treatment did not control emesis. CONCLUSIONS AND CLINICAL RELEVANCE: Many dogs with CPV-associated enteritis had persistent vomiting despite antiemetic administration. The apparent difference in duration of hospitalization between antiemetic-treated dogs and other dogs may reflect a difference in disease severity between groups, although antiemetic-associated adverse events (e.g., signs of depression, hypotension, and immune modulation) may prolong hospitalization.

Animals↗