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Abstract Details

Correlation between BMI and Total Daily Levodopa Requirements with Levodopa-Carbidopa Intestinal Gel Therapy: Results from Phase 3 Clinical Trials
Movement Disorders
Movement Disorders Posters (7:00 AM-5:00 PM)
072

Evaluate the relationship between body mass index (BMI) and total levodopa dose with Levodopa-Carbidopa Intestinal Gel (LCIG) therapy.

Pharmacological studies indicate body weight influences levodopa dose in Parkinson’s disease (PD). The correlation between baseline BMI and baseline levodopa dose and mean total levodopa dose over 12 months was assessed.

Post-hoc analysis included data from LCIG phase 3, open-label 12-month clinical trial subjects with advanced PD whose motor complications were inadequately controlled by oral medications. BMI was evaluated as a continuous and categorical variable according to the Center for Disease Control and Prevention (CDC), USA definitions of underweight (BMI<18.5), normal (18.5≤ BMI <25), overweight (25≤ BMI <30), and obesity (BMI ≥30). Pearson’s and Spearman’s correlation were calculated for continuous BMI; ANOVA and nonparametric Kruskal-Wallis analyses were performed for dosage difference between BMI groups.

The analysis included 412 patients. Baseline (standard deviation [SD]) oral levodopa dose (mg) for underweight, normal, overweight, and obese subjects was 1141.8 (913.64); 1093.2 (550.4); 1049 (502.36); 1123.5 (605.65), respectively; the mean (SD) total daily levodopa dose (mg) from LCIG and oral levodopa over 12 months was 1264.7 (501.39); 1442.2 (537.66); 1550.6 (592.91); 1617 (469.54). A positive, significant correlation was reported between baseline BMI and mean total LCIG and oral levodopa dose over 12 months (Pearson correlation, 0.1448, p=0.003; Spearman correlation, 0.1277, p=0.010; and confirmed by analyses treating BMI as CDC-recommended groups (ANOVA, p=0.026; Kruskal-Wallis, p=0.017). Adverse events (AEs) occurred in 20 (100%) underweight, 190 (90.9%) normal, 120 (94.5%) overweight, and 45 (88.2%) obese subjects with complication of device insertion (30.8%), abdominal pain (26%), and insomnia (18.4%) as the most reported AEs.  
Although weak, a significant positive correlation between baseline BMI and mean total LCIG and oral levodopa dose may suggest higher total levodopa is required to clinically optimize aPD patients with increased BMIs.
Authors/Disclosures
Leonard Verhagen Metman, MD, PhD (Northwestern University)
PRESENTER 		Dr. Verhagen Metman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AbbVie. Dr. Verhagen Metman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbott. Dr. Verhagen Metman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Mitsubishi Tanabe. Dr. Verhagen Metman has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Supernus. Dr. Verhagen Metman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for AbbVie. Dr. Verhagen Metman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Cerevel. Dr. Verhagen Metman has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Frontiers.
Ramon L. Rodriguez Cruz, MD, FÂ鶹´«Ã½Ó³»­ (Neurology One) The institution of Dr. Rodriguez Cruz has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbvie. The institution of Dr. Rodriguez Cruz has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Supernus . The institution of Dr. Rodriguez Cruz has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Neurocrine. The institution of Dr. Rodriguez Cruz has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Boston Scientific. The institution of Dr. Rodriguez Cruz has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Abbott. The institution of Dr. Rodriguez Cruz has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Acorda. The institution of Dr. Rodriguez Cruz has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Teva. The institution of Dr. Rodriguez Cruz has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Kyoway Kirin. The institution of Dr. Rodriguez Cruz has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie. The institution of Dr. Rodriguez Cruz has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Amneal. The institution of Dr. Rodriguez Cruz has received research support from Cerevance. The institution of Dr. Rodriguez Cruz has received research support from Neuraly. The institution of Dr. Rodriguez Cruz has received research support from Amneal. The institution of Dr. Rodriguez Cruz has received research support from Teva. The institution of Dr. Rodriguez Cruz has received research support from Neurocrine. Dr. Rodriguez Cruz has received publishing royalties from a publication relating to health care.
No disclosure on file
Pavnit Kukreja, PharmD (AbbVie) Dr. Kukreja has received personal compensation for serving as an employee of AbbVie. Dr. Kukreja has stock in AbbVie.
Omar Ladhani Omar Ladhani has received personal compensation for serving as an employee of AbbVie. Omar Ladhani has received stock or an ownership interest from AbbVie.
James T. Boyd, MD (University of Vermont Medical Center) Dr. Boyd has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for NeuroDerm . Dr. Boyd has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for InTrance. Dr. Boyd has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Neurocrine. Dr. Boyd has received personal compensation in the range of $500-$4,999 for serving as an officer or member of the Board of Directors for Parkinson Study Group . The institution of Dr. Boyd has received research support from NIA/NIH. The institution of Dr. Boyd has received research support from Biotie . The institution of Dr. Boyd has received research support from vaccinex. The institution of Dr. Boyd has received research support from CHDI. The institution of Dr. Boyd has received research support from AbbVie. The institution of Dr. Boyd has received research support from Roche . The institution of Dr. Boyd has received research support from Revance . The institution of Dr. Boyd has received research support from NeuroDerm. The institution of Dr. Boyd has received research support from Neurocrine .