Research Article: Levodopa/carbidopa/entacapone versus levodopa/benserazide plus pramipexole in Chinese patients with Parkinson’s disease experiencing wearing off
Abstract:
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).
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.
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.
LCE and LB?+?PPX were both effective, safe and tolerable in treating patients with PD who experienced WO.
Introduction:
Parkinson’s disease (PD), a progressive neurodegenerative disorder, has a prevalence of about 1.7% in people aged 65?years or older in China ( 1–6 ). In addition, it is estimated that in 2030, China will have close to half of the PD population in the world ( 5 , 6 ). Levodopa remains the “gold standard” treatment for motor symptoms of PD ( 1 , 2 ). Conventional levodopa formulations incorporate a dopa-decarboxylase (DDC) inhibitor (DDCI) such as carbidopa and benserazide to prevent peripheral conversion of…
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