Levodopa/carbidopa/entacapone versus levodopa/benserazide plus pramipexole in Chinese patients with Parkinson's disease experiencing wearing off.

OBJECTIVE

To compare the efficacy and safety of direct switch from levodopa/benserazide (LB) to levodopa/carbidopa/entacapone (LCE) versus LB plus pramipexole (PPX) in Chinese patients with Parkinson's disease (PD) experiencing wearing off (WO).

METHODS

In this multicenter, prospective, randomized, open-label, observational study, 140 patients with PD experiencing WO who had been on stable LB treatment were enrolled and randomized 3:2 to receive LCE (84) or LB + PPX (56) treatment for 8 weeks. The primary endpoint was change in the daily "OFF" time from baseline. Change in the daily "ON" time was also assessed. Treatment-emergent adverse events (TEAEs) were recorded.

RESULTS

Seventy-nine patients in the LCE group and 49 patients in the PPX group completed the study. Both LCE and PPX shortened the patients' daily OFF time significantly after 8 weeks (-1.76 ± 1.70 h, p < 0.001 and -1.51 ± 1.60, p < 0.001, respectively), and the shortenings were comparable between the two groups (p = 0.414). Correspondingly, both the LCE group and the PPX group had significantly increased daily ON time (1.62 ± 1.59 h, p < 0.001 and 1.38 ± 1.65, p < 0.001, respectively), and the increases were comparable between the two groups (p = 0.412). Both treatments improved the patients' WO symptoms, sleep quality, depression and quality of life. Six (7.59%) patients in the LCE group and 7 (14.29%) patients in the PPX group reported TEAEs, all of which were mild and tolerable. One patient in the LCE group and 2 patients in the PPX group experienced mild dyskinesia.

CONCLUSION

LCE and LB + PPX were both effective, safe and tolerable in treating patients with PD who experienced WO.