Double-blind, randomized crossover study of metoclopramide and batanopride for prevention of cisplatin-induced emesis. 1991

G F Fleming, and E E Vokes, and J M McEvilly, and L Janisch, and D Francher, and L Smaldone
Department of Medicine, University of Chicago, IL 60637.

We conducted a double-blind, randomized crossover study to compare the toxicity and antiemetic efficacy of the 5-hydroxytryptamine3 receptor antagonist batanopride with that of metoclopramide in 21 chemotherapy-naive patients receiving at least 70 mg/m2 cisplatin. The study was terminated when hypotension was observed following the infusion of batanopride at other institutions testing similar drug schedules. Although we observed no hypotension following treatment with batanopride in this trial, we did note asymptomatic prolongation of the corrected QT interval (QTc), PR interval, and QRS complex on the EKG in the batanopride arm. Of 15 evaluable patients, 8 experienced less than or equal to 2 episodes of emesis within 24 h of the first batanopride infusion, whereas 9/15 subjects experienced less than or equal to 2 emetic episodes following the administration of metoclopramide. Overall, the evidence suggests that this dosing schedule for batanopride may be too toxic for clinical use.

UI MeSH Term Description Entries
D007262 Infusions, Intravenous The long-term (minutes to hours) administration of a fluid into the vein through venipuncture, either by letting the fluid flow by gravity or by pumping it. Drip Infusions,Intravenous Drip,Intravenous Infusions,Drip Infusion,Drip, Intravenous,Infusion, Drip,Infusion, Intravenous,Infusions, Drip,Intravenous Infusion
D008787 Metoclopramide A dopamine D2 antagonist that is used as an antiemetic. 4-Amino-5-chloro-N-(2-(diethylamino)ethyl)-2-methoxybenzamide,Cerucal,Maxolon,Metaclopramide,Metoclopramide Dihydrochloride,Metoclopramide Hydrochloride,Metoclopramide Monohydrochloride,Metoclopramide Monohydrochloride, Monohydrate,Primperan,Reglan,Rimetin,Dihydrochloride, Metoclopramide,Hydrochloride, Metoclopramide,Monohydrochloride, Metoclopramide
D002945 Cisplatin An inorganic and water-soluble platinum complex. After undergoing hydrolysis, it reacts with DNA to produce both intra and interstrand crosslinks. These crosslinks appear to impair replication and transcription of DNA. The cytotoxicity of cisplatin correlates with cellular arrest in the G2 phase of the cell cycle. Platinum Diamminodichloride,cis-Diamminedichloroplatinum(II),cis-Dichlorodiammineplatinum(II),Biocisplatinum,Dichlorodiammineplatinum,NSC-119875,Platidiam,Platino,Platinol,cis-Diamminedichloroplatinum,cis-Platinum,Diamminodichloride, Platinum,cis Diamminedichloroplatinum,cis Platinum
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D004361 Drug Tolerance Progressive diminution of the susceptibility of a human or animal to the effects of a drug, resulting from its continued administration. It should be differentiated from DRUG RESISTANCE wherein an organism, disease, or tissue fails to respond to the intended effectiveness of a chemical or drug. It should also be differentiated from MAXIMUM TOLERATED DOSE and NO-OBSERVED-ADVERSE-EFFECT LEVEL. Drug Tolerances,Tolerance, Drug,Tolerances, Drug
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000932 Antiemetics Drugs used to prevent NAUSEA or VOMITING. Anti-emetic,Antiemetic,Antiemetic Agent,Antiemetic Drug,Anti-Emetic Effect,Anti-Emetic Effects,Anti-emetics,Antiemetic Agents,Antiemetic Drugs,Antiemetic Effect,Antiemetic Effects,Agent, Antiemetic,Agents, Antiemetic,Anti Emetic Effect,Anti Emetic Effects,Anti emetic,Anti emetics,Drug, Antiemetic,Drugs, Antiemetic,Effect, Anti-Emetic,Effect, Antiemetic,Effects, Anti-Emetic,Effects, Antiemetic
D013997 Time Factors Elements of limited time intervals, contributing to particular results or situations. Time Series,Factor, Time,Time Factor
D014839 Vomiting The forcible expulsion of the contents of the STOMACH through the MOUTH. Emesis

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