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Reducing dosing frequency of carbidopa/levodopa: double-blind crossover study comparing twice-daily bilayer formulation of carbidopa/levodopa (IPX054) versus 4 daily doses of standard carbidopa/levodopa in stable Parkinson disease patients.
Clin Neuropharmacol. 2009 Jul-Aug; 32(4):189-92.CN

Abstract

OBJECTIVE

We compared IPX054, a bilayer tablet of immediate- and extended-release carbidopa/levodopa (CD/LD) given twice daily to standard CD/LD given 4 times daily in patients with stable Parkinson disease (PD).

METHODS

Twelve PD patients with no or mild fluctuations on CD/LD 25/100 mg 4 times daily were randomized to a double-blind crossover comparison with IPX054 (50/200 mg) twice daily. At the end of each 2-week treatment, patients were video recorded while performing a modified Unified Parkinson's Disease Rating Scale motor examination and Rush Dyskinesia Rating Scale at 30-minute intervals over 8.5 hours. The primary outcome measure was the number of videotape epochs rated as "ON" without troublesome dyskinesia by a blinded observer (Wilcoxon signed rank tests).

RESULTS

The 9 men and 3 women had a mean age of 69 years and mean PD duration of 6 years. IPX054 and CD/LD showed no significant differences in the primary outcome measure (mean number of video epochs rated as ON without troublesome dyskinesia; P = 0.14). The mean time to ON was improved with IPX054 (P = 0.014), and the mean modified Unified Parkinson's Disease Rating Scale scores slightly favored IPX054 (14.4 vs 16.9; P = 0.052). Mean Rush Dyskinesia Rating Scale scores were not significantly different between IPX054 and CD/LD (0.45 vs 0.69; P = 0.25). No patient developed troublesome dyskinesias.

CONCLUSIONS

In stable PD patients, no difference was detected between twice-daily treatment with IPX054 and CD/LD given 4 times daily. In this group, substitution with IPX054 reduced dosing frequency while maintaining CD/LD efficacy. In clinical practice, this ease of administration may offer improved treatment compliance.

Authors+Show Affiliations

Department of Neurosciences, Medical University of South Carolina, Charleston, SC 29425, USA. hinsonvk@musc.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19620848

Citation

Hinson, Vanessa K., et al. "Reducing Dosing Frequency of Carbidopa/levodopa: Double-blind Crossover Study Comparing Twice-daily Bilayer Formulation of Carbidopa/levodopa (IPX054) Versus 4 Daily Doses of Standard Carbidopa/levodopa in Stable Parkinson Disease Patients." Clinical Neuropharmacology, vol. 32, no. 4, 2009, pp. 189-92.
Hinson VK, Goetz CG, Leurgans S, et al. Reducing dosing frequency of carbidopa/levodopa: double-blind crossover study comparing twice-daily bilayer formulation of carbidopa/levodopa (IPX054) versus 4 daily doses of standard carbidopa/levodopa in stable Parkinson disease patients. Clin Neuropharmacol. 2009;32(4):189-92.
Hinson, V. K., Goetz, C. G., Leurgans, S., Fan, W., Nguyen, T., & Hsu, A. (2009). Reducing dosing frequency of carbidopa/levodopa: double-blind crossover study comparing twice-daily bilayer formulation of carbidopa/levodopa (IPX054) versus 4 daily doses of standard carbidopa/levodopa in stable Parkinson disease patients. Clinical Neuropharmacology, 32(4), 189-92. https://doi.org/10.1097/WNF.0b013e3181a27fae
Hinson VK, et al. Reducing Dosing Frequency of Carbidopa/levodopa: Double-blind Crossover Study Comparing Twice-daily Bilayer Formulation of Carbidopa/levodopa (IPX054) Versus 4 Daily Doses of Standard Carbidopa/levodopa in Stable Parkinson Disease Patients. Clin Neuropharmacol. 2009 Jul-Aug;32(4):189-92. PubMed PMID: 19620848.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Reducing dosing frequency of carbidopa/levodopa: double-blind crossover study comparing twice-daily bilayer formulation of carbidopa/levodopa (IPX054) versus 4 daily doses of standard carbidopa/levodopa in stable Parkinson disease patients. AU - Hinson,Vanessa K, AU - Goetz,Christopher G, AU - Leurgans,Sue, AU - Fan,Wenqing, AU - Nguyen,Tiffany, AU - Hsu,Ann, PY - 2009/7/22/entrez PY - 2009/7/22/pubmed PY - 2009/10/9/medline SP - 189 EP - 92 JF - Clinical neuropharmacology JO - Clin Neuropharmacol VL - 32 IS - 4 N2 - OBJECTIVE: We compared IPX054, a bilayer tablet of immediate- and extended-release carbidopa/levodopa (CD/LD) given twice daily to standard CD/LD given 4 times daily in patients with stable Parkinson disease (PD). METHODS: Twelve PD patients with no or mild fluctuations on CD/LD 25/100 mg 4 times daily were randomized to a double-blind crossover comparison with IPX054 (50/200 mg) twice daily. At the end of each 2-week treatment, patients were video recorded while performing a modified Unified Parkinson's Disease Rating Scale motor examination and Rush Dyskinesia Rating Scale at 30-minute intervals over 8.5 hours. The primary outcome measure was the number of videotape epochs rated as "ON" without troublesome dyskinesia by a blinded observer (Wilcoxon signed rank tests). RESULTS: The 9 men and 3 women had a mean age of 69 years and mean PD duration of 6 years. IPX054 and CD/LD showed no significant differences in the primary outcome measure (mean number of video epochs rated as ON without troublesome dyskinesia; P = 0.14). The mean time to ON was improved with IPX054 (P = 0.014), and the mean modified Unified Parkinson's Disease Rating Scale scores slightly favored IPX054 (14.4 vs 16.9; P = 0.052). Mean Rush Dyskinesia Rating Scale scores were not significantly different between IPX054 and CD/LD (0.45 vs 0.69; P = 0.25). No patient developed troublesome dyskinesias. CONCLUSIONS: In stable PD patients, no difference was detected between twice-daily treatment with IPX054 and CD/LD given 4 times daily. In this group, substitution with IPX054 reduced dosing frequency while maintaining CD/LD efficacy. In clinical practice, this ease of administration may offer improved treatment compliance. SN - 1537-162X UR - https://www.unboundmedicine.com/medline/citation/19620848/Reducing_dosing_frequency_of_carbidopa/levodopa:_double_blind_crossover_study_comparing_twice_daily_bilayer_formulation_of_carbidopa/levodopa__IPX054__versus_4_daily_doses_of_standard_carbidopa/levodopa_in_stable_Parkinson_disease_patients_ L2 - https://doi.org/10.1097/WNF.0b013e3181a27fae DB - PRIME DP - Unbound Medicine ER -