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PubMed1993

Results of antiemetic management in terminal illness.

A wide variety of causes may be responsible for nausea and vomiting in terminal illness. The different emetic stimuli reach the vomiting centre by a variety of pathways and can be blocked by specific antiemetics that act at the neurotransmitter receptor sites in these pathways. A knowledge of the neurotransmitter receptor antagonist potency of the different antiemetics allows the choice of the most appropriate antiemetic for the relief of the nausea and vomiting caused by a particular emetic stimulus. To demonstrate the efficacy of this approach to the management of nausea and vomiting in terminal illness, the outcome of antiemetic choice in 100 consecutive episodes is recorded.

Adult↗
PubMed1993

Tiapride versus metoclopramide: comparison after minor gynaecological surgery.

Tiapride (Tiapridal, Delagrange), a dopaminergic D2 receptor blocking agent having anxiolytic, sedative, antiemetic and analgesic properties was compared with metoclopramide and placebo in a randomized double-blind trial to determine its effects on post-operative nausea, vomiting, and sedation. The agents were given intravenously immediately before induction of anaesthesia to 75 women scheduled for minor elective gynaecological surgery. A standardized anaesthetic technique was used in all the patients. In the recovery room anti-emetic and sedative effects of tiapride and metoclopramide were similar and significantly better (P < 0.001) than placebo. In the ward at the end of 5 h anti-emetic (P < 0.05), and sedative (P < 0.01) effects of tiapride were significantly better than both metoclopramide and placebo.

Abortion, Incomplete↗
PubMed1996

[Comparison of clinical effects between granisetron alone and combination of granisetron and methylprednisolone against the nausea and vomiting induced by CDDP chemotherapy--comparative study by the cross-over trial. University of Tsukuba Antiemetics Study Group].

A cross-over clinical trial was carried out to compare the antiemetic effect and safety between granisetron alone (40 micrograms/kg) and the combination of granisetron and methylprednisolone (MP: 10 mg/kg) in urological cancer patients treated with cisplatin. Forty-eight courses were given with granisetron alone and 47 courses with both granisetron and MP. The antiemetic effect of nausea and vomiting was evaluated in the acute emetic phase. during the 24 hours following the CDDP administration, and in the delayed emetic phase, 2 to 7 days after the administration. Combination therapy of granisetron and MP demonstrated a greater antiemetic effect during the 72 hours following the CDDP administration than by granisetron alone. But there was no significant difference in antiemetic effect between combination therapy and granisetron alone after the 3rd day. Combination therapy also demonstrated more efficacy in complete antiemetic effect, with no emesis and less than moderate nausea, than by granisetron alone. Both treatments showed no side effects and were safe.

Aged↗
PubMed1995

Granisetron (IV) compared with ondansetron (IV plus oral) in the prevention of nausea and vomiting induced by moderately-emetogenic chemotherapy. A cross-over study.

The French Northern Oncology Group carried out a randomised, cross-over study comparing two anti-emetic treatment strategies in 150 chemotherapy-naive patients, receiving their first two courses of moderately-emetogenic drugs. Nausea and vomiting were assessed using a self-administered questionnaire for five days. Anti-emetic treatments consisted of granisetron (G) 3 mg intravenously (iv) before chemotherapy or ondansetron (O) 8 mg intravenously, followed by 8 mg orally every eight hours for the next three days (for a total of 9 tablets). No significant difference was detected between treatment regimens in terms of their ability to control either acute vomiting (no vomiting - G = 72%; O = 77%) or acute nausea (no nausea - G = 54%; O = 47%), nor in terms of the number of total responders, (no emesis and no nausea) on day 1 (G = 52%; O = 45%) or on days 1- 5 ( mean G - 37%; O = 32%). Furthermore, there was also no significant difference between patient preference for the two treatments, either with regard to efficacy (G = 39%; O = 34%) or tolerability (G = 29%; O = 27%). In conclusion, no difference was observed between the two treatments.

Administration, Oral↗
PubMed1995

[Methodology of the evaluation of antiemetics].

A number of clinical trials have only recently been conducted in the evaluation of chemotherapy-induced emesis prophylaxis. This is related to the development of new antiemetic drugs, the 5-HT3 serotoninergic receptors antagonists which are very effective. Methodological principles of drug development have been respected for the commercialization of this new class of antiemetics. The essential phase I and II studies have allowed to establish the maximal tolerated doses and the efficacy-dose relation in order to conduct phase III clinical trials. At this time, the reference treatment for emesis was metoclopramide and thus, phase III trials have been initially conducted with this comparative treatment. These randomized studies have been carried out in parallel group and in double-blind in accordance with a methodology adapted to cancer. The inclusion criteria have allowed to define an homogeneous population of chemotherapy naive patients and clinical trials have been conducted with a stratification related to the emetic power of the chemotherapy. The number of patients to include in the studies was calculated related to the expected efficacy rates of the comparative drugs. The evaluation criteria of nausea and vomiting were standardized and the primary clinical end point to assess the efficacy of antiemetic agents was determined by a complete control (no emetic episode). Nausea, which is a more subjective criterion, was assessed by the patient himself and the results could be included in the global analysis. Furthermore, the persistence of the efficacy over repeated courses has been assessed by clinical trials carried out on two to six cycles.

Adolescent↗
PubMed1977

Centrally mediated intestinal stimulation by morphine.

A study was designed to examine the effects of intraventricularly (i.vt.) administered morphine, apomorphine and epinephrine on the small intestine. Adult cats of either sex were implanted chronically with extracellular, monopolar electrodes at equal intervals along the entire small intestine. A collison cannula was placed in the left lateral cerebral ventricle in each animal. In animals that did not respond with emesis, morphine sulfate (200 micron g) administered i.vt. increased the incidence of spike potentials over the proximal three-quarters of the small intestine almost immediately. The response to i.vt. morphine was abolished by pretreatment with i.vt. naloxone HC1 (200 micron g) and was not obtained after peripheral (i.p.) injection of morphine at the same dose effective centrall. Now change in the number of spike potentials occure after i.vt. administration of two other potent emetic agents, apomorphine HC1 (200 micron g) and epinephrine HC1 (15O micron g), in animals that did not respond with emesis. The results suggest that the increased incidence of spike potentials after i.vt. morphine is a naloxone-sensitive, centrally mediated event not associated with activation of the central emetic mechanism.

Action Potentials↗
PubMed1996

Repeated administration of the 5-HT3 receptor antagonist granisetron reduces the incidence of delayed cisplatin-induced emesis in the piglet.

We analyzed the effects of the 5-HT3 receptor antagonist granisetron on both acute and delayed phases of cisplatin-induced emesis in the conscious piglet. Animals that received a high dose of cisplatin (5.5 mg/kg i.v.) were observed continuously for 60 h. Seventeen piglets were treated with cisplatin only and acted as controls. In experimental animals, granisetron (administered before cisplatin) was administered either as a single initial injection (7 mg/kg), alone or in combination with dexamethasone (40 mg), or as multiple injections (1 mg/kg) given every 5 h during the first 30 h of the experiment (cumulative dose: 7 mg/kg). Two other groups of piglets were treated with dexamethasone (40 mg) alone or with multiple injections of ondansetron (7 injections at 3.5 mg/kg), respectively. The latency to the first emetic episode was significantly increased in all groups that received a 5-HT3 receptor antagonist, whatever the agent and the protocol of administration. Piglets treated solely with dexamethasone exhibited a latency similar to that of controls. The total number of emetic events during the 60 h was significantly reduced only in the group of piglets treated repeatedly with granisetron and in the group that received an initial dose (7 mg/kg) of granisetron in combination with dexamethasone. We observed that 3 out of 8 piglets treated repeatedly with granisetron did not vomit throughout the experiment. These results demonstrate that granisetron, when administered repeatedly, is efficacious against delayed emesis. They also suggest that serotonin may be involved in the production of the delayed phase of cisplatin-induced emesis.

Animals↗
PubMed1995

Neuropharmacological mechanisms of emesis. II. Effects of antiemetic drugs on cisplatin-induced pica in rats.

The effects of diphenhydramine, domperidone, ondansetron, and diphenidol on cisplatin-induced pica (i.e., kaolin ingestion) in rats as the measure analogous to emesis in other species were examined. Ondansetron (2 mg/kg) and diphenidol (30 mg/kg) inhibited kaolin intake induced by cisplatin (10 mg/kg), but diphenhydramine and domperidone did not. Diphenhydramine and diphenidol have been shown to inhibit kaolin intake induced by double rotation, while domperidone and ondansetron did not, and kaolin intake induced by apomorphine was inhibited by domperidone and diphenidol, but not by diphenhydramine or ondansetron. These observations, together with the present findings, suggest that the emetic pathways through the inner ear (double rotation), chemoreceptor trigger zone (apomorphine) and visceral afferent (cisplatin), are pharmacologically independent and are mediated by histamine H1 receptors, dopamine D2 receptors and serotonin 5-HT3 receptors, respectively. It is conceivable that diphenidol may inhibit the emetic center itself, although the receptor on which it acts is not known.

Animal Feed↗
PubMedDate not supplied

[Ondansetron in the prevention of radiation-induced nausea and emesis in patients treated with single-fraction irradiation].

INTRODUCTION: Intensity and severity of radiation-induced nausea and emesis depend on a number of factors including irradiation site, irradiation dose, treatment field (width and length), and age of the patients. Although less intensive than that induced by chemotherapy, during protracted courses of fractionated radiotherapy discomfort can be substantial. As early as 1953, Court-Brown [2] described characteristic symptoms after a single-fraction radiotherapy as "acute irradiation syndrome": irradiation was followed by asymptomatic period of 40-90 minutes, after that the patient experienced an acute episode of emesis, usually without preceding nausea. After a period of relative stabilization, additional episodes of emesis occurred for six hours after irradiation, decreasing its intensity with time. Danjoux et al. [5] noted a higher incidence of radiation-induced emesis after the upper half-body irradiation (UHBI) than after the lower half-body irradiation (LHBI), lack of efficacy of antiemetics administered, and similar response to emesis after the lower or the upper half-body irradiation. These results suggested that critical area was the upper abdomen. Although the exact mechanism of occurrence of radiation-induced emesis is still unknown, recent studies revealed that serotonin released from the gastrointestinal tract also produced emesis through mechanisms of involvement of 5-hydroxytriptamines (5-HT3) receptors, visceral afferent fibers and chemoreceptor trigger zone. We have, therefore, used a new 5-HT3 antagonist, ondansetron, in prevention of radiation-induced emesis in patients treated with single-fraction radiotherapy. MATERIAL AND METHODS: All patients included in the study had bone metastases treated for pain relief and in all of them, the entire or a part of the upper abdomen was enclosed in the treatment field. The patients' characteristics are given in Table 1. Patients in group I had vertebral lesions that required the central radiation field at Th8-L3 level. Patients in group II were treated with LHBI-the upper field border at crista illiaca; those in group III with UHBI-the lower field border at umbilicus, while those treated with mid-half-body irradiation had the lower field border at the floor of the pelvis. Patients in group I received 8 mg of ondansetron orally, three times a day, for 3-5 days after irradiation. Those in groups II-IV received 0.15 mg/kg of ondansetron intravenously 15 minutes before HBI, just on the day of irradiation. To verify patients' data we used a special questionnaire. Emetic episodes were defined as every emetic episode with minimal interval of 1 minute between separate episodes. Response to therapy was considered complete (no episodes within 24 hours), major response (with only 1-2 episodes), minor (3-5 episodes) and no response (more than 5 episodes of emesis or administration of additional new antiemetics). RESULTS: In group I, 93% of patients had complete response within 24 hours, while 7% had major response of emesis. Regarding nausea, 89% had complete lack of nausea, while 11% had moderate nausea. In the next 5 days, 96-100% of patients had complete response or major response. At the same time, nausea was controlled in more than 80% of patients. In group II, there was a 100% response rate regarding nausea and emesis lasting for 5 days after radiation therapy. Patients in groups III and IV had also a 100% response rate regarding both nausea and vomiting. Side-effects of ondansetron administration were not observed. DISCUSSION: The results of this pilot study showed the excellent effect of the new 5-HT3 antagonist, ondansteron, in prevention of radiation-induced nausea and emesis. They confirmed results of the other authors [9, 10, 11] that used this antiemetic in the control of radiation-induced emesis. These studies included a variety of radiotherapeutic time-dose fractionation schedules, and some of them [11] included results of the total body irradiation. (ABSTRACT TRUN

Antiemetics↗
PubMedDate not supplied

Improved control of high-dose-cisplatin-induced acute emesis with the addition of prochlorperazine to granisetron/dexamethasone.

PURPOSE: To evaluate the antiemetic efficacy and safety of adding the dopamine antagonist prochlorperazine to the combination of granisetron and dexamethasone in the prevention of acute nausea and vomiting following high-dose cisplatin. PATIENTS AND METHODS: Sixty patients receiving cisplatin (> or = 75 mg/m2) (median dose = 100 mg/m2) were enrolled at three sites. Patients received prochlorperazine spansule 15 mg orally, 60 minutes prior to and 12 hours after cisplatin; dexamethasone 20 mg intravenously, 45 minutes prior to cisplatin, and 10 mg intravenously or orally, 12 hours after cisplatin; and granisetron 10 micrograms/kg intravenously, 30 minutes prior to cisplatin. Efficacy was assessed during the 24-hour period after cisplatin using complete antiemetic response (no emetic episodes and no rescue antiemetics) and patient assessment of nausea and satisfaction using 100-mm visual analog scales (nausea: 0 = none, 100 = nausea as bad as it can be; satisfaction: 0 = not at all satisfied, 100 = satisfied as can be). RESULTS: Complete response (0 emetic episodes) was noted in 84% (49/58) of patients. Forty-two patients (72%) experienced no nausea. The mean change in posttreatment nausea visual analog scales from baseline was 8.9 mm. Forty-eight patients (83%) were completely satisfied with their antiemetic treatment. The mean posttreatment patient satisfaction score was 92 mm. Treatment was well tolerated, with infrequent and minor adverse events. CONCLUSIONS: This three-drug antiemetic regimen is well tolerated and highly effective in the prevention of acute nausea and vomiting arising from high-dose cisplatin. Further studies evaluating this regimen are warranted.

Acute Disease↗
PubMed1997

Controlling conditioning-related emesis in children undergoing bone marrow transplantation.

PURPOSE/OBJECTIVES: To compare the efficacy of two antiemetic regimens, ondansetron alone versus perphenazine with diphenhydramine, on emesis control in children undergoing conditioning therapy for bone marrow transplantation (BMT). DESIGN: Single-center, prospective, open, randomized, crossover study. SETTING: Pediatric BMT unit in an urban area in the northeastern United States. SAMPLE: 28 children, ages 4-17, undergoing BMT for a variety of underlying diseases. METHODS: After randomization to one of the two antiemetic regimens, emesis control was evaluated during conditioning therapy. If a participant experienced more than five episodes of emesis during any 12-hour period, he or she was crossed over to the other antiemetic regimen. If emesis control still was not achieved, the participant was removed from the study and other medications were administered to control vomiting. MAIN RESEARCH VARIABLES: Number of emetic episodes and incidence of side effects. FINDINGS: 10 of 15 patients (67%) who received ondansetron experienced major emesis control (no more than two episodes) compared with 0 of 13 patients (0%) who received perphenazine with diphenhydramine (p = 0.044, Fisher exact test). Of those who crossed over to ondansetron after failure with perphenazine and diphenhydramine, 38% were able to achieve major emesis control. CONCLUSIONS: Ondansetron offers superior antiemetic control over the combination of perphenazine and diphenhydramine for children undergoing high-dose chemotherapy with or without total body irradiation for BMT. IMPLICATIONS FOR NURSING PRACTICE: Oncology nurses must develop an understanding of the etiology of therapy-induced emesis and the mechanisms of action of the various classes of antiemetic agents designed to control it. Implementing documentation to describe events of emesis will help to tailor antiemetic therapy to a patient's specific situation. Further research is necessary to determine alternate strategies, including different combinations or sequences of antiemetics to provide optimum emetic control during acute and delayed phases of emesis. The higher cost of ondansetron therapy must be considered within the context of superior efficacy.

Adolescent↗
PubMed1998

[Efficacy of combination of ondansetron injection and tablet in CAF-induced emesis in breast cancer patients].

Efficacy of combination of ondansetron injection and tablet on CAF (cyclophosphamide, adriamycin, 5-fluorouracil) induced emesis were investigated in 10 breast cancer patients (33 courses). Complete suppression rate of nausea or vomiting were approximately 75%, approximately 90% respectively for every treatment day. According to judgement criteria, antiemetic rate of approximately 100% was achieved during the study period. As to food intake of each treatment day, in approximately 70% of treatment courses was assessed as '(patient was) able to eat most of the meal'. Trend in emetic episodes and food intake in each patient receiving several courses of CAF therapy were evaluated. As a result, those patients experiencing nausea or vomiting or had effect on their food intake, were found to be in the similar condition in the following course (s) of CAF. No adverse drug reaction nor clinical laboratory test abnormalities due to ondansetron was observed. In this investigation, combination of ondansetron injection and tablet was shown to sufficiently suppress CAF-induced nausea and vomiting, and their efficacy was confirmed. Still, the study suggested that number of emetic episodes or degree of anorexia differs according to each individual. Therefore we regard additional administration of ondansetron or concomitant use of steroids should be considered when necessary.

Administration, Oral↗
PubMed1976

Management of acid-peptic esophageal strictures.

Eighty-nine patients with benign acid-peptic strictures of the esophagus were evaluated. Of these, 56 patients were treated by dilatation and medical therapy, whereas 33 underwent operative therapy because medical therapy failed. Three patients, all psychotic and having post-emetic strictures, required resection of the stricture and a colon interposition. Twenty-nine patients underwent a Belsey or Nissen fundoplication combined with esophageal dilatation. Fourteen of 29 had an associated vagotomy and 15 did not. Two patients of this 29 had a poor result, one of whom had a post-emetic stricture. Although the patients having a concurrent vagotomy and pyloroplasty had the more severe disease,there was no significant difference between the results in the two groups. It is concluded that most patients with such esophageal strictures may be adequately treated without resecting the stricture and that the routine addition of a vagotomy and drainage procedure is probably not indicated.

Aged↗
PubMed1998

Post operative nausea and vomiting in Nigerians.

A retrospective survey of postoperative nausea and vomiting (PONV) in the recovery room over a five year period was conducted, followed by a prospective study of 200 adult patients to estimate the incidence and predisposing factors to nausea and vomiting during the first 24 hours after anaesthesia and surgery in Nigerians. In the retrospective study only records of 61 patients (0.79%) out of the 7714 post anaesthetic recovery room charts reviewed revealed documentation of vomiting. These were 20 males (32.8%) and 41 females (67.2%). In the prospective study, the incidence of post operative nausea and vomiting within twenty four hours of surgery was 41.6% and 19.6%, respectively. But only two out of 39 patients (one per cent) vomited within the first three hours in postoperative period. The frequency of vomiting varied from one to 15 times and women had significantly more emetic symptoms than men (p < 0.05). Preoperative administration of pethidine and morphine was associated with postoperative nausea and vomiting. It is suggested that Nigerian women should be considered for prophylactic anti-emetic therapy, especially when narcotic analgesic are to be employed in their anaesthetic management.

Adult↗
PubMed1998

[Granisetron (per os) compared with ondansetron (per os) in the prevention of nausea and vomiting induced by mildly emetogenic chemotherapies. Groupe de Recherches en Cancerologie du Nord].

It is a randomised cross-over multicenter study comparing the efficacy and the tolerance of granisetron (Gra) 1 mg and ondansetron (Ond) 8 mg, oral, given during two consecutive cycles to 188 naive patients scheduled to receive a moderately emetogenic chemotherapy. The antiemetic treatment is given one day per course, 1 hour before chemotherapy and the second administration from 8 to 12 hours after the beginning, during each of the two cycles; alternatively according to the randomisation. Five criteria are assessed; nausea (ordinal and visual analogic scales), emeric episodes (vomiting orland retching), complete response (minor or no nausea, no emetic episode and no rescue treatment), patient preference and tolerance. The intent to treat analysis showed no significant difference at cycle 1 between Gra and Ond; at cycle 2, there is no significant difference in the number of emetic episodes; for the prevention of nausea, the ordinal scale shows a significant difference (p = 0.028 in favour of Gra at day 1 (D1) but not from D2 to D5. Gra induced more complete response than Ond at D1 (p = 0.028), but not from D2 to D5. The cross-over study did not show any period or order effect, whereas a treatment effect on Ond was significant in favour of Gra (p = 0.01). There is no significant patients preference in favour of Gra or Ond. In conclusion, Gra was more efficient in preventing nausea and obtaining complete response on the first day of treatment, significantly at the second cycle. Both Gra and Ond had a good antiemetic activity for moderately emetogenic chemotherapy with complete response rates always over 50% on day 1; delayed emesis remain less weli controlled.

Adult↗
PubMed1998

Report on the antiemetic effectivity of a single 1 mg oral granisetron in moderately emetogenic chemotherapies of gynecological malignancies.

OBJECTIVE: On the basis of the relatively long 9-12 hour plasma-half-life of the highly selective serotonin antagonist granisetron (GRAN) and on observations that emetic episodes are detected mainly 10 hours after starting chemotherapy it was supposed that a single 1 mg oral GRAN (Kytril, SmithKline Beecham) is enough to prevent the emesis of moderately emetogenic chemotherapies. MATERIALS AND METHODS: A total of 45 gynecological cancer patients were treated in 115 chemotherapy cycles with a single 1 mg oral GRAN in a prospective, non-randomized study. Patients stayed in hospital for 24 hours after chemotherapy and emetic episodes were registered on special charts. RESULTS: A complete response (CR) of 83.4% was found in the 115 cycles. Thirty-seven of the total 45 patients with ovarian cancer had a 84.7% CR in the first 24 hours of chemotherapy. In 29 patients 50 mg/m2 cisplatin was administered with a 79.9% CR. CONCLUSIONS: 1 mg oran GRAN is a suitable antiemetic therapy in moderately emetogenic chemotherapies.

Administration, Oral↗
PubMed1998

Rapidly reversible cardiomyopathy associated with chronic ipecac ingestion.

Ipecac, an over-the-counter emetic agent, has been a drug of choice for abuse by patients with eating disorders. Its alkaloid emetine has been associated with serious cardiac toxicity; however, the dose effect has not been well established. We present a patient with anorexia and bulimia nervosa who ingested ipecac chronically and developed the characteristic manifestations of ipecac toxicity. Unexpectedly, her induced left ventricular dysfunction returned to normal after only 10 days of withholding the drug. This finding, in contrast with the findings of other reports, establishes that ipecac cardiomyopathy can be readily reversible. The cumulative experience thus far, nonetheless, provides no discernible pattern of the effect of ipecac on the myocardium. Thus, in the continuum of poisoning, the point at which the myocardium becomes irreversibly damaged is undetermined. With continued abuse, potentially lethal outcome, and limited experience with ipecac cardiotoxicity, further investigation and perhaps heightened restriction of the drug are warranted.

Adult↗
PubMed1976

Derivatives of apomorphine and of other N-substituted norapomorphines.

Derivatives of apomorphine and of N-n-propylnorapomorphine were prepared to obtain modified pharmacological activity and enhanced chemical stability. Mouse profile and dog emesis screens were performed, and the activity of various N-substituted derivatives and their esters was evaluated and compared to the parent compounds. The N-n-propyl diacetate derivative and N-methyl and N-n-propyl ascorbate salts were remarkably stable to air: apomorphine etherate was no more stable than the free base. The dimers, the major products formed during the acid-catalyzed rearrangement of morphines to apomorphines, were all potent emetics. Additionally, two showed a significant antagonism to morphine in mice and dogs.

Animals↗