PMID- 18978491 OWN - NLM STAT- MEDLINE DCOM- 20090904 LR - 20131121 IS - 1537-162X (Electronic) IS - 0362-5664 (Linking) VI - 32 IP - 2 DP - 2009 Mar-Apr TI - Open-label study assessment of safety and adverse effects of subcutaneous apomorphine injections in treating "off" episodes in advanced Parkinson disease. PG - 89-93 LID - 10.1097/WNF.0B013E31816D91F9 [doi] AB - 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. FAU - LeWitt, Peter A AU - LeWitt PA AD - Department of Neurology, Wayne State University School of Medicine and Henry Ford Hospital, Detroit, MI 48034, USA. palewitt@ameritech.net FAU - Ondo, William G AU - Ondo WG FAU - Van Lunen, Brenda AU - Van Lunen B FAU - Bottini, Peter B AU - Bottini PB LA - eng PT - Clinical Trial PT - Journal Article PL - United States TA - Clin Neuropharmacol JT - Clinical neuropharmacology JID - 7607910 RN - 0 (Antiparkinson Agents) RN - N21FAR7B4S (Apomorphine) SB - IM MH - Accidental Falls MH - Aged MH - Antiparkinson Agents/*administration & dosage/*adverse effects MH - Apomorphine/*administration & dosage/*adverse effects MH - Drug Administration Schedule MH - Electrocardiography/methods MH - Female MH - Heart Rate/drug effects MH - Humans MH - Injections, Subcutaneous/methods MH - Male MH - Middle Aged MH - Parkinson Disease/*drug therapy/physiopathology MH - Retrospective Studies MH - Severity of Illness Index MH - Time Factors MH - Treatment Outcome EDAT- 2008/11/04 09:00 MHDA- 2009/09/05 06:00 CRDT- 2008/11/04 09:00 PHST- 2008/11/04 09:00 [pubmed] PHST- 2009/09/05 06:00 [medline] PHST- 2008/11/04 09:00 [entrez] AID - 00002826-900000000-99975 [pii] AID - 10.1097/WNF.0B013E31816D91F9 [doi] PST - ppublish SO - Clin Neuropharmacol. 2009 Mar-Apr;32(2):89-93. doi: 10.1097/WNF.0B013E31816D91F9.