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Open-label study assessment of safety and adverse effects of subcutaneous apomorphine injections in treating "off" episodes in advanced Parkinson disease.
Clin Neuropharmacol. 2009 Mar-Apr; 32(2):89-93.CN

Abstract

OBJECTIVE

To assess the safety and adverse effect profile of continued use of intermittent subcutaneous apomorphine to treat "off" episodes in subjects with advanced Parkinson disease.

METHODS

The study enrolled subjects with Hoehn and Yahr stage II-V Parkinson disease who were experiencing "off" events despite an optimized oral medication regimen. After baseline assessment and subcutaneous apomorphine dose titration (2-10mg/dose), subjects received > or =12 months of open-label treatment, as needed, for "off" episodes.

RESULTS

Of the 546 subjects in the study population, the majority used apomorphine on a daily basis; the average dose was 4.0 mg. A total of 187 subjects discontinued treatment because of adverse events (AEs). Most AEs were mild to moderate and expected with apomorphine. The AEs most commonly classified as definitely, probably, or possibly treatment related were nausea and vomiting, dyskinesia, dizziness, somnolence, hallucination, yawning, and injection site bruising. Serious AEs occurred in 199 subjects, but only 27 were considered to be probably or possibly treatment related. None of the 45 deaths recorded in the study were attributed to apomorphine.

CONCLUSIONS

Long-term use of intermittent apomorphine dosing for treatment of "off" episodes was generally associated with mild-to-moderate AEs.

Authors+Show Affiliations

Department of Neurology, Wayne State University School of Medicine and Henry Ford Hospital, Detroit, MI 48034, USA. palewitt@ameritech.netNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article

Language

eng

PubMed ID

18978491

Citation

LeWitt, Peter A., et al. "Open-label Study Assessment of Safety and Adverse Effects of Subcutaneous Apomorphine Injections in Treating "off" Episodes in Advanced Parkinson Disease." Clinical Neuropharmacology, vol. 32, no. 2, 2009, pp. 89-93.
LeWitt PA, Ondo WG, Van Lunen B, et al. Open-label study assessment of safety and adverse effects of subcutaneous apomorphine injections in treating "off" episodes in advanced Parkinson disease. Clin Neuropharmacol. 2009;32(2):89-93.
LeWitt, P. A., Ondo, W. G., Van Lunen, B., & Bottini, P. B. (2009). Open-label study assessment of safety and adverse effects of subcutaneous apomorphine injections in treating "off" episodes in advanced Parkinson disease. Clinical Neuropharmacology, 32(2), 89-93. https://doi.org/10.1097/WNF.0B013E31816D91F9
LeWitt PA, et al. Open-label Study Assessment of Safety and Adverse Effects of Subcutaneous Apomorphine Injections in Treating "off" Episodes in Advanced Parkinson Disease. Clin Neuropharmacol. 2009 Mar-Apr;32(2):89-93. PubMed PMID: 18978491.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Open-label study assessment of safety and adverse effects of subcutaneous apomorphine injections in treating "off" episodes in advanced Parkinson disease. AU - LeWitt,Peter A, AU - Ondo,William G, AU - Van Lunen,Brenda, AU - Bottini,Peter B, PY - 2008/11/4/pubmed PY - 2009/9/5/medline PY - 2008/11/4/entrez SP - 89 EP - 93 JF - Clinical neuropharmacology JO - Clin Neuropharmacol VL - 32 IS - 2 N2 - OBJECTIVE: To assess the safety and adverse effect profile of continued use of intermittent subcutaneous apomorphine to treat "off" episodes in subjects with advanced Parkinson disease. METHODS: The study enrolled subjects with Hoehn and Yahr stage II-V Parkinson disease who were experiencing "off" events despite an optimized oral medication regimen. After baseline assessment and subcutaneous apomorphine dose titration (2-10mg/dose), subjects received > or =12 months of open-label treatment, as needed, for "off" episodes. RESULTS: Of the 546 subjects in the study population, the majority used apomorphine on a daily basis; the average dose was 4.0 mg. A total of 187 subjects discontinued treatment because of adverse events (AEs). Most AEs were mild to moderate and expected with apomorphine. The AEs most commonly classified as definitely, probably, or possibly treatment related were nausea and vomiting, dyskinesia, dizziness, somnolence, hallucination, yawning, and injection site bruising. Serious AEs occurred in 199 subjects, but only 27 were considered to be probably or possibly treatment related. None of the 45 deaths recorded in the study were attributed to apomorphine. CONCLUSIONS: Long-term use of intermittent apomorphine dosing for treatment of "off" episodes was generally associated with mild-to-moderate AEs. SN - 1537-162X UR - https://www.unboundmedicine.com/medline/citation/18978491/Open_label_study_assessment_of_safety_and_adverse_effects_of_subcutaneous_apomorphine_injections_in_treating_"off"_episodes_in_advanced_Parkinson_disease_ L2 - https://doi.org/10.1097/WNF.0B013E31816D91F9 DB - PRIME DP - Unbound Medicine ER -