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 ≥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 ≥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.