The antiemetic efficacy of tropisetron plus dexamethasone as compared with conventional metoclopramide‐dexamethasone combination in Orientals receiving cisplatin chemotherapy: a randomized crossover trial

1We report a single‐blind randomized crossover trial comparing the efficacy of tropisetron plus dexamethasone (TROPDEX) vs conventional combination of metoclopramide, dexamethasone and diphenhydramine (METDEX) in prevention of acute and delayed vomiting in Chinese patients receiving high dose cispla...

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Veröffentlicht in:British journal of clinical pharmacology 1996-05, Vol.41 (5), p.403-408
Hauptverfasser: CHUA, D. T. T., SHAM, J. S. T., AU, G. K. H., CHOY, D., KWONG, D. L. W., YAU, C. C., CHENG, A. C. K.
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container_issue 5
container_start_page 403
container_title British journal of clinical pharmacology
container_volume 41
creator CHUA, D. T. T.
SHAM, J. S. T.
AU, G. K. H.
CHOY, D.
KWONG, D. L. W.
YAU, C. C.
CHENG, A. C. K.
description 1We report a single‐blind randomized crossover trial comparing the efficacy of tropisetron plus dexamethasone (TROPDEX) vs conventional combination of metoclopramide, dexamethasone and diphenhydramine (METDEX) in prevention of acute and delayed vomiting in Chinese patients receiving high dose cisplatin. 2Thirty‐six consecutive patients with nasopharyngeal carcinoma were entered into the study, all received cisplatin at a dose range of 60–100 mg/m2. Patients were randomized in the sequence of antiemetic regimens used in two consecutive cycles. 3The TROPDEX regimen consisting of tropisetron 5 mg i.v. and dexamethasone 20 mg i.v. given on day 1 of chemotherapy, followed by oral maintenance with tropisetron 5 mg daily and dexamethasone 4 mg twice daily from day 2 to 6. The METDEX regimen consisting of metoclopramide 1 mg kg−1 i.v., dexamethasone 20 mg i.v. and diphenhydramine 25 mg i.v. given before chemotherapy and then 2 hourly for two more doses on day 1, followed by oral metoclopramide 20 mg 6 hourly from day 2 to 6. 4Complete control of acute vomiting was observed in 64% of patients with TROPDEX as compared with 14% with METDEX (P
doi_str_mv 10.1046/j.1365-2125.1996.03268.x
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T. T. ; SHAM, J. S. T. ; AU, G. K. H. ; CHOY, D. ; KWONG, D. L. W. ; YAU, C. C. ; CHENG, A. C. K.</creator><creatorcontrib>CHUA, D. T. T. ; SHAM, J. S. T. ; AU, G. K. H. ; CHOY, D. ; KWONG, D. L. W. ; YAU, C. C. ; CHENG, A. C. K.</creatorcontrib><description>1We report a single‐blind randomized crossover trial comparing the efficacy of tropisetron plus dexamethasone (TROPDEX) vs conventional combination of metoclopramide, dexamethasone and diphenhydramine (METDEX) in prevention of acute and delayed vomiting in Chinese patients receiving high dose cisplatin. 2Thirty‐six consecutive patients with nasopharyngeal carcinoma were entered into the study, all received cisplatin at a dose range of 60–100 mg/m2. Patients were randomized in the sequence of antiemetic regimens used in two consecutive cycles. 3The TROPDEX regimen consisting of tropisetron 5 mg i.v. and dexamethasone 20 mg i.v. given on day 1 of chemotherapy, followed by oral maintenance with tropisetron 5 mg daily and dexamethasone 4 mg twice daily from day 2 to 6. The METDEX regimen consisting of metoclopramide 1 mg kg−1 i.v., dexamethasone 20 mg i.v. and diphenhydramine 25 mg i.v. given before chemotherapy and then 2 hourly for two more doses on day 1, followed by oral metoclopramide 20 mg 6 hourly from day 2 to 6. 4Complete control of acute vomiting was observed in 64% of patients with TROPDEX as compared with 14% with METDEX (P&lt;0.01). While complete plus major control of acute vomiting was observed in 84% with TROPDEX as compared with 58% with METDEX. The mean vomiting episodes on day 1 were 1.4 with TROPDEX as compared with 3.5 with METDEX (P&lt;0.01). There was, however, no significant difference between the two regimens in the control of delayed vomiting. 5When patients randomized to TROPDEX in the second cycle were compared with those with TROPDEX in the first cycle, the antiemetic efficacy was reduced, with mean acute vomiting episodes of 2 in the former compared with 0.8 in the latter (P&lt;0.01). 6The most common adverse effect observed was headache in TROPDEX (27%) and dizziness in METDEX (40%). 7In conclusion, the antiemetic regimen TROPDEX is effective in Chinese patients receiving high dose cisplatin chemotherapy and is well tolerated. 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T. T.</creatorcontrib><creatorcontrib>SHAM, J. S. T.</creatorcontrib><creatorcontrib>AU, G. K. H.</creatorcontrib><creatorcontrib>CHOY, D.</creatorcontrib><creatorcontrib>KWONG, D. L. W.</creatorcontrib><creatorcontrib>YAU, C. C.</creatorcontrib><creatorcontrib>CHENG, A. C. K.</creatorcontrib><title>The antiemetic efficacy of tropisetron plus dexamethasone as compared with conventional metoclopramide‐dexamethasone combination in Orientals receiving cisplatin chemotherapy: a randomized crossover trial</title><title>British journal of clinical pharmacology</title><addtitle>Br J Clin Pharmacol</addtitle><description>1We report a single‐blind randomized crossover trial comparing the efficacy of tropisetron plus dexamethasone (TROPDEX) vs conventional combination of metoclopramide, dexamethasone and diphenhydramine (METDEX) in prevention of acute and delayed vomiting in Chinese patients receiving high dose cisplatin. 2Thirty‐six consecutive patients with nasopharyngeal carcinoma were entered into the study, all received cisplatin at a dose range of 60–100 mg/m2. Patients were randomized in the sequence of antiemetic regimens used in two consecutive cycles. 3The TROPDEX regimen consisting of tropisetron 5 mg i.v. and dexamethasone 20 mg i.v. given on day 1 of chemotherapy, followed by oral maintenance with tropisetron 5 mg daily and dexamethasone 4 mg twice daily from day 2 to 6. The METDEX regimen consisting of metoclopramide 1 mg kg−1 i.v., dexamethasone 20 mg i.v. and diphenhydramine 25 mg i.v. given before chemotherapy and then 2 hourly for two more doses on day 1, followed by oral metoclopramide 20 mg 6 hourly from day 2 to 6. 4Complete control of acute vomiting was observed in 64% of patients with TROPDEX as compared with 14% with METDEX (P&lt;0.01). While complete plus major control of acute vomiting was observed in 84% with TROPDEX as compared with 58% with METDEX. The mean vomiting episodes on day 1 were 1.4 with TROPDEX as compared with 3.5 with METDEX (P&lt;0.01). There was, however, no significant difference between the two regimens in the control of delayed vomiting. 5When patients randomized to TROPDEX in the second cycle were compared with those with TROPDEX in the first cycle, the antiemetic efficacy was reduced, with mean acute vomiting episodes of 2 in the former compared with 0.8 in the latter (P&lt;0.01). 6The most common adverse effect observed was headache in TROPDEX (27%) and dizziness in METDEX (40%). 7In conclusion, the antiemetic regimen TROPDEX is effective in Chinese patients receiving high dose cisplatin chemotherapy and is well tolerated. It is better than conventional METDEX regimen in the control of acute vomiting, but not in the control of delayed vomiting.</description><subject>antiemesis</subject><subject>Antiemetics - therapeutic use</subject><subject>Antineoplastic Agents - adverse effects</subject><subject>Asian Continental Ancestry Group</subject><subject>Biological and medical sciences</subject><subject>Chinese</subject><subject>cisplatin</subject><subject>Cisplatin - adverse effects</subject><subject>Cross-Over Studies</subject><subject>dexamethasone</subject><subject>Dexamethasone - therapeutic use</subject><subject>Digestive system</subject><subject>Diphenhydramine - therapeutic use</subject><subject>Drug Therapy, Combination</subject><subject>Female</subject><subject>Hong Kong</subject><subject>Humans</subject><subject>Indoles - therapeutic use</subject><subject>Male</subject><subject>Medical sciences</subject><subject>metoclopramide</subject><subject>Metoclopramide - therapeutic use</subject><subject>Middle Aged</subject><subject>Nasopharyngeal Neoplasms - drug therapy</subject><subject>Original</subject><subject>Pharmacology. Drug treatments</subject><subject>Single-Blind Method</subject><subject>Tropisetron</subject><subject>Vomiting - chemically induced</subject><subject>Vomiting - prevention &amp; control</subject><issn>0306-5251</issn><issn>1365-2125</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1996</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkc9u1DAQxiMEKkvhEZB84Jpg54-TIIQEK_5JlcqhnK2JM2m8SuzITre7nHiEPlkfgidh0l2t6I2Tbc33-2Y8XxQxwRPBc_l2k4hMFnEq0iIRdS0TnqWySnZPotWp8DRa8YzLuEgL8Tx6EcKGc5EJWZxFZ1WZFbISq-j-qkcGdjY44mw0w64zGvSeuY7N3k0mIB2WTcNNYC3ugGQ9BGeJCky7cQKPLbs1c08vu0WychYGRjqnBzd5GE2Lf37fPYaJbIyFRcyMZZfeEAlDYB41mq2x10ybMA2ksEz3OLq5Rw_T_h0D5sG2bjS_qLH2LgS3RU_TGhheRs86csFXx_M8-vnl89X6W3xx-fX7-uNFrPO6lHEruJQyh07LppYCueZ1XtZAm8xSXXOZ5VWFbSM1lmldQ142DTFl0SJKXuXZefTh4DvdNCO2mob3MKjJmxH8Xjkw6nHFml5du61KeZ5KzsmgOhg8fMBjd2IFV0vEaqOWJNWSpFoiVg8Rqx2hr__tfQKPmVL9zbEOQcPQ0bZolSdZxqu0KiTJ3h9kt2bA_X-3V5_WP-iW_QWmxcu7</recordid><startdate>199605</startdate><enddate>199605</enddate><creator>CHUA, D. T. T.</creator><creator>SHAM, J. S. T.</creator><creator>AU, G. K. H.</creator><creator>CHOY, D.</creator><creator>KWONG, D. L. W.</creator><creator>YAU, C. C.</creator><creator>CHENG, A. C. K.</creator><general>Blackwell Science Ltd</general><general>Blackwell Science</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>5PM</scope></search><sort><creationdate>199605</creationdate><title>The antiemetic efficacy of tropisetron plus dexamethasone as compared with conventional metoclopramide‐dexamethasone combination in Orientals receiving cisplatin chemotherapy: a randomized crossover trial</title><author>CHUA, D. T. T. ; SHAM, J. S. T. ; AU, G. K. H. ; CHOY, D. ; KWONG, D. L. W. ; YAU, C. C. ; CHENG, A. C. 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Drug treatments</topic><topic>Single-Blind Method</topic><topic>Tropisetron</topic><topic>Vomiting - chemically induced</topic><topic>Vomiting - prevention &amp; control</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>CHUA, D. T. T.</creatorcontrib><creatorcontrib>SHAM, J. S. T.</creatorcontrib><creatorcontrib>AU, G. K. H.</creatorcontrib><creatorcontrib>CHOY, D.</creatorcontrib><creatorcontrib>KWONG, D. L. W.</creatorcontrib><creatorcontrib>YAU, C. C.</creatorcontrib><creatorcontrib>CHENG, A. C. 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K.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The antiemetic efficacy of tropisetron plus dexamethasone as compared with conventional metoclopramide‐dexamethasone combination in Orientals receiving cisplatin chemotherapy: a randomized crossover trial</atitle><jtitle>British journal of clinical pharmacology</jtitle><addtitle>Br J Clin Pharmacol</addtitle><date>1996-05</date><risdate>1996</risdate><volume>41</volume><issue>5</issue><spage>403</spage><epage>408</epage><pages>403-408</pages><issn>0306-5251</issn><eissn>1365-2125</eissn><coden>BCPHBM</coden><abstract>1We report a single‐blind randomized crossover trial comparing the efficacy of tropisetron plus dexamethasone (TROPDEX) vs conventional combination of metoclopramide, dexamethasone and diphenhydramine (METDEX) in prevention of acute and delayed vomiting in Chinese patients receiving high dose cisplatin. 2Thirty‐six consecutive patients with nasopharyngeal carcinoma were entered into the study, all received cisplatin at a dose range of 60–100 mg/m2. Patients were randomized in the sequence of antiemetic regimens used in two consecutive cycles. 3The TROPDEX regimen consisting of tropisetron 5 mg i.v. and dexamethasone 20 mg i.v. given on day 1 of chemotherapy, followed by oral maintenance with tropisetron 5 mg daily and dexamethasone 4 mg twice daily from day 2 to 6. The METDEX regimen consisting of metoclopramide 1 mg kg−1 i.v., dexamethasone 20 mg i.v. and diphenhydramine 25 mg i.v. given before chemotherapy and then 2 hourly for two more doses on day 1, followed by oral metoclopramide 20 mg 6 hourly from day 2 to 6. 4Complete control of acute vomiting was observed in 64% of patients with TROPDEX as compared with 14% with METDEX (P&lt;0.01). While complete plus major control of acute vomiting was observed in 84% with TROPDEX as compared with 58% with METDEX. The mean vomiting episodes on day 1 were 1.4 with TROPDEX as compared with 3.5 with METDEX (P&lt;0.01). There was, however, no significant difference between the two regimens in the control of delayed vomiting. 5When patients randomized to TROPDEX in the second cycle were compared with those with TROPDEX in the first cycle, the antiemetic efficacy was reduced, with mean acute vomiting episodes of 2 in the former compared with 0.8 in the latter (P&lt;0.01). 6The most common adverse effect observed was headache in TROPDEX (27%) and dizziness in METDEX (40%). 7In conclusion, the antiemetic regimen TROPDEX is effective in Chinese patients receiving high dose cisplatin chemotherapy and is well tolerated. It is better than conventional METDEX regimen in the control of acute vomiting, but not in the control of delayed vomiting.</abstract><cop>Oxford</cop><pub>Blackwell Science Ltd</pub><pmid>8735681</pmid><doi>10.1046/j.1365-2125.1996.03268.x</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record>
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language eng
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source MEDLINE; EZB-FREE-00999 freely available EZB journals; Alma/SFX Local Collection
subjects antiemesis
Antiemetics - therapeutic use
Antineoplastic Agents - adverse effects
Asian Continental Ancestry Group
Biological and medical sciences
Chinese
cisplatin
Cisplatin - adverse effects
Cross-Over Studies
dexamethasone
Dexamethasone - therapeutic use
Digestive system
Diphenhydramine - therapeutic use
Drug Therapy, Combination
Female
Hong Kong
Humans
Indoles - therapeutic use
Male
Medical sciences
metoclopramide
Metoclopramide - therapeutic use
Middle Aged
Nasopharyngeal Neoplasms - drug therapy
Original
Pharmacology. Drug treatments
Single-Blind Method
Tropisetron
Vomiting - chemically induced
Vomiting - prevention & control
title The antiemetic efficacy of tropisetron plus dexamethasone as compared with conventional metoclopramide‐dexamethasone combination in Orientals receiving cisplatin chemotherapy: a randomized crossover trial
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