title: Conversion to carbidopa and levodopa extended-release (IPX066) followed by its extended use in patients previously taking controlled-release carbidopa-levodopa for advanced Parkinson's disease.
abstract: BACKGROUND
  IPX066 (Rytary®; carbidopa and levodopa [CD-LD] extended-release capsules) was designed to achieve therapeutic LD plasma concentrations within 1h of dosing and maintain LD concentrations for a prolonged duration in early or advanced Parkinson's disease (PD).
  
  
  METHODS
  In this open-label study, patients underwent 6weeks of conversion to IPX066 from their prior controlled-release (CR)±immediate-release (IR) CD-LD therapy and 6months of maintenance (with an additional 6months of IPX066 at some sites). Clinical utility was assessed at both the end of conversion and maintenance.
  
  
  RESULTS
  Among 43 patients initiated on IPX066, 33 completed conversion. The mean LD conversion ratio was 1.8 among 30 patients previously on CR plus IR (and 1.5 among 3 previously taking CR alone). The mean IPX066 dosing frequency was 3.5times/day compared with 2.6times/day for CR plus 4.6times/day for IR previously (and 4.7times/day for CR alone). By patient and clinician global improvement ratings after 6-month maintenance, ≥43.8% of patients were much or very much improved from their previous treatment, and ≥68.8% were at least minimally improved. Adverse events were consistent with those reported in prior IPX066 studies.
  
  
  CONCLUSIONS
  These results suggest that advanced PD patients using CR CD-LD±IR can be safely converted to IPX066, with high likelihood of achieving a stable regimen, less frequent LD dosing, and improved overall clinical benefit.
  
  
  BACKGROUND
  Clinicaltrials.govNCT01411137.
authors.affiliation: The Parkinson's Institute and Clinical Center, 675 Almanor Ave, Sunnyvale, CA 94085, USA. Electronic address: jtetrud@stanford.edu.
authors.forename: James
authors.initials: J
authors.lastname: Tetrud
authors.affiliation: Wisconsin Institute for Neurologic and Sleep Disorders, 945 N 12th St, Milwaukee, WI 53233, USA. Electronic address: nausiedamd@parkcent.com.
authors.forename: Paul
authors.initials: P
authors.lastname: Nausieda
authors.affiliation: The Parkinson's Disease and Movement Disorders Center of Long Island, 283 Commack Rd, Commack, NY 11725, USA. Electronic address: PDMDCLI@aol.com.
authors.forename: David
authors.initials: D
authors.lastname: Kreitzman
authors.affiliation: The Parkinson's Institute and Clinical Center, 675 Almanor Ave, Sunnyvale, CA 94085, USA. Electronic address: graceliangmd@gmail.com.
authors.forename: Grace S
authors.initials: GS
authors.lastname: Liang
authors.affiliation: Munroe Regional Medical Center, 13940 US-441, Lady Lake, FL 32159, USA. Electronic address: Anette_Nieves@munroeregional.com.
authors.forename: Anette
authors.initials: A
authors.lastname: Nieves
authors.affiliation: University of Cincinnati, 2600 Clifton Ave, Cincinnati, OH 45220, USA. Electronic address: dukeraa@ucmail.uc.edu.
authors.forename: Andrew P
authors.initials: AP
authors.lastname: Duker
authors.affiliation: University of South Florida, 4202 E Fowler Ave, Tampa, FL 33620, USA. Electronic address: rhauser@health.usf.edu.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Hauser
authors.affiliation: University of Nevada School of Medicine, 1707 W Charleston Blvd, Las Vegas, NV 89102, USA. Electronic address: efarbman@medicine.nevada.edu.
authors.forename: Eric S
authors.initials: ES
authors.lastname: Farbman
authors.affiliation: Quest Research Institute, 28595 Orchard Lake Rd #301, Farmington Hills, MI 48334, USA. Electronic address: aellenbogen@comcast.net.
authors.forename: Aaron
authors.initials: A
authors.lastname: Ellenbogen
authors.affiliation: Impax Laboratories, Inc., 31047 Genstar Road, Hayward, CA 94544, USA. Electronic address: annhsu@aol.com.
authors.forename: Ann
authors.initials: A
authors.lastname: Hsu
authors.affiliation: Impax Laboratories, Inc., 31047 Genstar Road, Hayward, CA 94544, USA. Electronic address: skell@impaxlabs.com.
authors.forename: Sherron
authors.initials: S
authors.lastname: Kell
authors.affiliation: Impax Laboratories, Inc., 31047 Genstar Road, Hayward, CA 94544, USA. Electronic address: skhanna@impaxlabs.com.
authors.forename: Sarita
authors.initials: S
authors.lastname: Khanna
authors.affiliation: Impax Laboratories, Inc., 31047 Genstar Road, Hayward, CA 94544, USA. Electronic address: rrubens@impaxlabs.com.
authors.forename: Robert
authors.initials: R
authors.lastname: Rubens
authors.affiliation: Impax Laboratories, Inc., 31047 Genstar Road, Hayward, CA 94544, USA. Electronic address: sgupta@impaxlabs.com.
authors.forename: Suneel
authors.initials: S
authors.lastname: Gupta
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000978:Antiparkinson Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002230:Carbidopa / Q000009:adverse effects / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D004334:Drug Administration Schedule; D004338:Drug Combinations; D057915:Drug Substitution; D005260:Female; D006801:Humans; D007980:Levodopa / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000188:drug therapy*; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000978:Antiparkinson Agents; D003692:Delayed-Action Preparations; D004338:Drug Combinations; C009265:carbidopa, levodopa drug combination; D007980:Levodopa; D002230:Carbidopa
keywords: Carbidopa; Carbidopa and levodopa controlled-release; Carbidopa and levodopa extended-release; Dose conversion; IPX066; Levodopa; Parkinson's disease