Tolcapone in elderly patients with Parkinson's disease: a prospective open-label multicenter non-interventional trial.
Safety and efficacy of tolcapone was studied in 237 patients with advanced Parkinson's disease (PD) in a prospective, open-label, multicenter, non-interventional trial. Main outcome measures were tolerability (adverse events=AE) and safety parameters (liver enzymes). A subgroup analysis was performed for patients at < 70 years and > or = 70 years of age. Improvement of symptoms based on investigator global assessment was reported in 84% of all patients: 14.8% greatly improved, 42.6% improved, and 27% slightly improved. Slight worsening was reported in only 2.6% of subjects. There were no significant differences concerning the treatment efficacy between the age subgroups (p=0.74). The incidence of AE was slightly higher in the subgroup of patients > or = 70 years than in the subgroup of patients < 70 years (relative risk, RR=3.03; 95% confidence interval, CI=1.04-8.96; p=0.03), but AE judged as potentially related to tolcapone were equally distributed among both groups (8.5% vs. 2.9%, RR: 2.91; CI=0.82-10.27; p=0.08). Diarrhea was the most common potentially tolcapone-related AE in both groups. Elevations of liver enzymes (aspartate aminotransferase=AST, and alanine aminotransferase=ALT) above the upper limit of normal were observed in 19% (CI=8.3-23.4) of all patients with slightly but not statistically significant higher percentages in the young patients group compared to older patient group (RR=0.54; CI=0.28-1.04; p=0.06). This observational study provides evidence that tolcapone can be effectively and safely used for the treatment of response fluctuations in elderly patients with PD.
Ebersbach
Georg
G
Movement Disorder Clinic, Neurologisches Fachkrankenhaus für Bewegungs störungen/Parkinson, Paracelsusring 6a, 14547 Beelitz-Heilstätten, Germany. ebersbach@parkinson-beelitz.de
Storch
Alexander
A
D000368:Aged; D000369:Aged, 80 and over; D000978:Antiparkinson Agents / Q000627:therapeutic use*; D001577:Benzophenones / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009596:Nitrophenols / Q000627:therapeutic use*; D010300:Parkinson Disease / Q000188:drug therapy*; D011446:Prospective Studies; D000077867:Tolcapone
D000978:Antiparkinson Agents; D001577:Benzophenones; D009596:Nitrophenols; D000077867:Tolcapone