Randomized, placebo-controlled trial of trimethobenzamide to control nausea and
vomiting during initiation and continued treatment with subcutaneous apomorphine
injection.
Author(s): Hauser RA(1), Isaacson S(2), Clinch T(3); The Tigan/Apokyn Study Investigators.
Affiliation(s): Author information:
(1)University of South Florida, Tampa, FL, USA. Electronic address:
rhauser@health.usf.edu.
(2)Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton, FL,
USA.
(3)US WorldMeds, LLC, Louisville, KY, USA.
Publication date & source: 2014, Parkinsonism Relat Disord. ,
BACKGROUND: Nausea and vomiting can occur in Parkinson's disease (PD) patients
initiated on apomorphine subcutaneous injections and antiemetic prophylaxis is
recommended per product labeling. Data suggest long-term antiemetic prophylaxis
may not be needed, although this has not been systematically studied.
METHODS: We evaluated coadministered trimethobenzamide with apomorphine in 182 PD
subjects using a randomized, double-blind, placebo-controlled design, with phased
withdrawal of subjects from trimethobenzamide to placebo. Evaluations included
presence/absence of nausea and vomiting; Index of Nausea, Vomiting, and Retching
(INVR); subject evaluation of medication; Unified Parkinson's Disease Rating
Scale (UPDRS) motor score; "on" response post-injection; and safety assessments.
RESULTS: Incidence of nausea and/or vomiting on Day 1 of apomorphine initiation
(primary endpoint) was not significantly different between trimethobenzamide and
placebo. Over a longer period, a significantly lower incidence was found for
trimethobenzamide during Period 1 (Days 1-28, p = 0.025) and Period 2 (Days
29-56, p = 0.005), with no difference during Period 3 (Days 57-84). INVR results
were generally more favorable with trimethobenzamide than placebo in Period 1 and
significantly more favorable in Period 2. The majority of subjects in both groups
achieved an "on" response after apomorphine injection at all assessments. No
significant differences were found between groups for UPDRS motor scores. No
added safety risk with concomitant use of trimethobenzamide and apomorphine was
found.
CONCLUSION: Our data suggest that trimethobenzamide helps reduce nausea/vomiting
during the first 8 weeks of apomorphine therapy, but is generally not needed
thereafter. Trimethobenzamide did not worsen parkinsonism nor affect "on"
response after apomorphine injection.
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