Examination of the correlation of serum metoclopramide levels with antiemetic efficacy in patients receiving cisplatin
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Metoclopramide
Dopamine antagonist
A comparison of the antiemetic effects of (H) and (M) was carried out by randomized control study in gynecologic cancer patients receiving CDDP (35-110 mg/m2). Metoclopramide was given at a dosage of 2 mg/kg (H) or 1 mg/kg (M), intravenously, 30 minutes before and 2.5 hours, 5.0 hours, and 7.5 hours following chemotherapy. Treatment with (H) resulted in 3.3 episodes of vomiting (range 0-5) whereas the episodes of vomiting noted with (M) were 3.4 (range 1-5). In patients receiving CDDP (H) or (M) dosage of metoclopramide gives similar antiemetic protection.
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In 29 patients (48 courses of chemotherapy), a randomized double-blind crossover study was undertaken to establish the antiemetic effectivness of a combination of metoclopramide at a moderately high dose (5 mg/kg body weight) with 1 g methylprednisolone (treatment A) as compared with metoclopramide monotherapy (5 mg/kg body weight; treatment B). With cisplatin doses of 60 mg/m2, a good antiemetic effect (0–1 vomiting episodes in 24 h) was observed in 9 out of 10 patients under treatment A as well as under treatment B. With a cisplatin dose of 120 mg/m2, treatment A produced a good antiemetic effect in 9 out of 11 patients (82%), while treatment B produced such an effect in only 3 out of 11 patients (27%; p <0.5). The results obtained permit the following conclusions to be made: At doses of cisplatin of up to 60 mg/m2, the antiemetic effect produced by metoclopramide (5 mg/kg body weight) given alone is adequate. At doses of cisplatin of 120 mg/m2 and more, high-dose methylprednisolone has a good additive antiemetic effect vis-à-vis metoclopramide (5 mg/kg body weight). The antiemetic effect of this combination corresponds approximately to the antiemetic effect produced with high-dose metoclopramide (10 mg/kg body weight) administered alone.
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Sixteen of 26 patients given 51 courses of treatment of the doxorubicin and cisplatin combination with no antiemetic therapy suffered the same number of vomiting episodes and had the same duration of vomiting as did the remaining ten patients given 20 cycles of this chemotherapy plus the standard high-dose metoclopramide regimen. This antiemetic regimen caused significant side effects in one fifth of the patients receiving it.
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The antiemetic effects of domperidone in patients undergoing post-surgical cytostatic treatment for stomach and colorectal carcinoma have been evaluated. The study has been performed on 3 groups of patients treated with domperidone, metoclopramide and placebo respectively. The antiemetic activity of domperidone proved to be better than that of metoclopramide. No side effects were observed in patients treated with domperidone.
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Abstract Objective: To determine whether intermediate dose metoclopramide is more effective than standard dose metoclopramide for patients who present to the ED with nausea and vomiting. Methods: This prospective, single‐blind, randomized trial was conducted in the ED of two community teaching hospitals in a convenience sample of adult patients who presented to ED with nausea and vomiting. Patients were randomized to receive either 10 mg metoclopramide IV or 0.4 mg/kg IV (up to a maximum dose of 32 mg). The outcomes measured were: change in nausea score (measured on a 11‐point verbal rating scale), requirement for other anti‐emetic drug administration, and presence of side‐effects. Results: Fifty‐eight patients were eligible for analysis (34 in 10 mg group and 24 in 0.4 mg/kg group). Median reduction in nausea score in 10 mg group was four (range 0–10, 95% CI 3–5) compared with five for 0.4 mg/kg group (range −1–10, 95% CI 4–6). This difference was not statistically significant ( P = 0.629). Five patients in the 10 mg group required rescue anti‐emetic, compared with three in the 0.4 mg/kg group ( P = 1.00). There were no side‐effects in the 10 mg group and two in the 0.4 mg/kg group. Conclusion: This study suggests that there is no difference in effectiveness between 10 mg and 0.4 mg/kg of metoclopramide in the ED population with nausea and vomiting.
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A series of consecutive trials were undertaken to determine whether higher doses of intravenous metoclopramide and combinations of metoclopramide, dexamethasone, and diphenhydramine would improve antiemetic control or decrease treatment-related side effects in patients receiving cisplatin at 120 mg/m2. Metoclopramide and dexamethasone were studied because of their proven efficacy as single agents and their differing mechanisms of action and side effects. Diphenhydramine was used because of its possible antiemetic properties and its ability to control acute dystonic reactions. Two hundred fifty-five patients who had never received chemotherapy or antiemetics were observed in the hospital for the 24 hours following cisplatin administration. The addition of dexamethasone or dexamethasone plus diphenhydramine to intravenous metoclopramide 2 mg/kg produced both improved antiemetic control and a decrease in treatment-associated diarrhea (P = 0.002). The use of metoclopramide alone at a dose of 3 mg/kg for only two doses appeared as effective as 2 mg/kg for five doses. When dexamethasone and diphenhydramine were given with metoclopramide 3 mg/kg for two intravenous dosages, 81% of patients experienced no emesis and 93% had two or fewer vomiting episodes. The antiemetic results of this 2-hour "short-course" regimen were superior to metoclopramide 2 mg/kg, with (P = 0.002) or without (P = 0.0001) dexamethasone and diphenhydramine. It was concluded that combinations of metoclopramide plus dexamethasone plus diphenhydramine improve antiemetic control, facilitate the usage of higher doses of metoclopramide, and decrease the incidence of treatment-related side effects.
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The present trial with high oral doses of metoclopramide was undertaken to (a) determine a well-tolerated dosage of oral metoclopramide; (b) measure the blood levels achieved with these oral doses; (c) determine the side effects of high doses; and (d) observe for antiemetic efficacy. Thirty-six patients receiving emesis-producing chemotherapy consisting primarily of high intravenous (i.v.) doses of cyclophosphamide plus adriamycin or cisplatin received 48 courses of oral metoclopramide. The metoclopramide dosage was escalated in six steps from 0.5 to 3.0 mg/kg and was given 1/2 h before chemotherapy, then 1½, 3½, 7½, 11½, and 15½ h after chemotherapy. Diphenhydramine (50 mg orally) was given with the first, third, and fifth dosages. Toxicity was generally mild, not dose related, and similar to that observed with the i.v. drug with the exception of an increased incidence of acute dystonic reactions. Antiemetic effects were observed at each dose level. In patients receiving oral metoclopramide doses of 2 or 3 mg/kg, all achieved serum levels > 1,000 ng/ml. High-dosage oral metoclopramide was well tolerated and demonstrated antiemetic effects at the dose levels explored. We recommend 2–3 mg/kg oral metoclopramide doses with 50 mg diphenhydramine for use in future trials.
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