INTRODUCTION: We have performed a systematic literature review to evaluate the current evidence of the pharmacokinetic (PK), efficacy and safety profile of oral melevodopa/carbidopa fixed combination in the management of motor fluctuations in patients with Parkinson disease (PD). EVIDENCE ACQUISITION: Search has been started from common libraries and was then restricted to articles of studies in humans with melevodopa/carbidopa as fixed combination. Abstracts of international congresses have been also explored. The search has led to the identification of one PK study and five efficacy/safety studies that included more 743 PD patients overall, 488 of which treated with melevodopa/carbidopa effervescent tablets (Sirio®, Chiesi Farmaceutici S.p.A., Parma, Italy). EVIDENCE SYNTHESIS: Melevodopa/carbidopa has a more rapid absorption, less apparent drug accumulation, less inter-patient variability and more effective LD delivery after the early morning and early afternoon dose compared to standard LD. Although they differed in used dose regimens, duration of treatment and endpoints, the results of the efficacy/safety studies suggest that treatment with melevodopa/carbidopa may determine improvements in motor fluctuations compared to treatment with standard LD/CD formulations, with no increased risk of adverse effects or LD-induced dyskinesias. CONCLUSIONS: Data from literature have shown that melevodopa/carbidopa in a highly soluble formulation as effervescent oral tablets is effective in improving control of motor complications in PD patients compared to conventional levodopa. Further research is needed to confirm this evidence in large controlled trials and to explore if melevodopa/carbidopa may have a potential role in the earlier phases of the disease or in special PD populations.
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